IDMP with PLG

A Stitch in Time
Understanding and
Preparing for the IDMP
from a Strategic Level
Outsourcing and Consulting Services for Life Sciences
www.productlife-group.com
REPORT

www.productlife-group.com i
A Stitch in Time: Understanding and Preparing for the IDMP from a Strategic Level
Regulatory Deadline: Driven by EU Legislation........................................................................................2
Top Level: How IDMP Differs from XEVMPD..............................................................................................3
Important Set of Standards with Significant Implications for Industry...........................................4
A Closer Look at the Standards ......................................................................................................................5
Relationship between XEVMPD and IDMP .............................................................................................10
Implementation Plans and Needs..............................................................................................................12
Overall Plans and Timelines..........................................................................................................................14
Moving Ahead for Industry...........................................................................................................................14
References...........................................................................................................................................................15
Table of Contents

www.productlife-group.com 1
As the Identification of Medicinal Products (IDMP) was
coming into clearer focus, ProductLife Group worked
with Andrew Marr as part of PLG Evolve, ProductLife
Group’s thought leadership programme, to develop
and publish a formative paper on this important issue.
The regulators have made clear their intention to meet
the 1 July 2016 legislative deadline for implementation
of IDMP. An expansive and widely encompassing set of
standards, the IDMP is a significant undertaking for all
parties—the authorities, committees, and experts involved
in its development and implementation—and for the
organisations that will be affected by its introduction—
namely, life sciences companies.
IDMP is expected to be used for a wide range of regulatory
purposes and beyond, making it a far more comprehensive
set of standards than the eXtended EudraVigilance
Medicinal Product Dictionary (XEVMPD), which it will
replace. For companies, the ability to control their data
in order to respond to any and all requirements will be a
most important aspect. They will need to know where to
find their data—whether regulatory, pharmacovigilance,
quality, or manufacturing—and how best to assemble
it. To do so, companies need to ensure their regulatory
information management systems (RIMs) are able to
manage all information related to their product portfolios
on a global basis.
Taking a strategic approach to the IDMP requires
companies to have their own internal processes and RIM
strategies in place and that they be in a position to quickly
react to content in the implementation guides as the
guides become available; that availability is expected
to start in mid 2015.
IDMP is a significant undertaking, but it also presents
opportunities in terms of how companies manage and
share data—and particularly as a way to support master
data management initiatives.
This paper explores what IDMP is, its broader potential
across life sciences and health care, and the implications
for companies in the lead-up to implementation.
—Erick Gaussens, Chief Scientific Officer
ProductLife Group

Regulatory Deadline: Driven by EU Legislation
The implementation of IDMP is being driven by legislation in the European Union (EU). The Commission
Implementing Regulation of 19 June 20121
stipulates that the International Organization for Standardization (ISO)
standard for IDMP will be used for the provision of medicinal product information, that the implementation date
is 1 July 2016, and that IDMP will also be used in the context of submission of Individual Case Safety Reports, a
new version of which, based on the ISO standard,2
is to be implemented at the same time. Thus, XEVMPD will be
replaced by IDMP, which has a significantly wider scope.
The European regulators have made clear their intention that IDMP will be used in support of a broad range of
regulatory requirements beyond capturing the data associated with initial registrations and life-cycle submissions
in support of pharmacovigilance. With that in mind, the European Medicines Agency is currently working with
its experts, committees, and the wider regulatory network of national competent authorities to define additional
requirements for provision of data that will support the following areas.
• Clinical trials—particularly in the context of the new clinical trials regulation
• Scientific advice
• Paediatric usage
• Inspections and quality
Assessment of the potential use of IDMP for clinical trials and scientific advice demonstrates the desire to capture
information early in a medicine’s life cycle. That would facilitate continuity of tracking once the product is
authorised for marketing. Potential use for inspections and quality could significantly expand the applicability of
IDMP because use in those areas does not necessarily involve dossier content. For example, the manufacturer of
excipients is not in the dossier but should be known to the manufacturing company. Because the inspectorate and
regulators require this data to be provided centrally, the data’s availability could facilitate management of issues of
potential contamination, a problem that has arisen in the past. The European Medicines Agency plans to report on
its assessment later in 2014 and to propose the use cases and required data once IDMP has been implemented.
The use of IDMP has potentially greater reach beyond regulatory processes. Projects are being initiated by the
European Commission3
to support provision of individual-patient health-care records between countries and to
support the filling of electronic prescriptions in another country. It is highly likely that IDMP will play a significant
role in those endeavours.

The IDMP standards were published in October 2012, but there is much to do before they can be implemented.
Implementation guides need to be written, agreed on, and published; processes defined and implemented;
vocabularies developed, published, and readied for maintenance; and systems for data management and
submission delivery and receipt developed, tested, and implemented. The regulators are working diligently
towards the deadline and are committed to meeting it, but with so much to accomplish and so many earlier
deadlines to be met first, achieving the goal of 1 July 2016 implementation will be tight.
There are many lessons to be learned from XEVMPD, the most notable of them that time will be needed to pull
good data together and manage it well. Two years is not a long time to prepare, considering the complexity and
breadth of the data involved. Unlike with XEVMPD, when timelines allowed companies to adopt only tactical
solutions, for IDMP strategic approaches should be considered; and companies are advised to prepare for that
now and not be forced into making a knee-jerk reaction in the final few months before implementation.
Two significant lessons to be learned from XEVMPD are that companies need to be in control of their data and
that to be able to provide quality data there must be good guidance that companies can interpret in only one
way. For many companies, that was not achieved—at least in the early stages of XEVMPD, when their RIMs and
the data held within them were not up to the required breadth, depth, and quality. At many companies, that
issue is in the process of being rectified, but IDMP will put a further strain on their ability to manage data.
IDMP also has far wider geographic scope than the XEVMPD had, because it is not confined to Europe. Other
regulators beyond those in the EU will be implementing IDMP; however, they do not have the legislative deadlines
to target. The US Food and Drug Administration (FDA), in particular, is putting significant effort into moving the
implementation support activities along—both within and outside ISO.
Top Level: How IDMP Differs from XEVMPD
IDMP is a set of global standards, developed in collaboration between regulators,
industry, and health informatics professions. Although the initial purpose was the
identification of substances and medicines for pharmacovigilance purposes, during
the process of development of the standards the scope became significantly
broader, encompassing many other regulatory-use cases. The result is something
much broader and deeper than XEVMPD.
Because the development of the standards took place in collaboration with health
informatics standards organisations, IDMP is not an isolated set of standards the
way XEVMPD is. IDMP is better designed than XEVMPD and will correct many of
the problems seen with XEVMPD and for which inelegant workarounds have been
required, such as handling multiple languages in a country and supporting the
identification of multiple presentations within the same authorisation.
The data required for XEVMPD was predominantly already held by regulatory
affairs, although for the majority of companies, some additional data had to be collected from within regulatory
affairs. In addition, a typically limited amount of information came from pharmacovigilance and drug safety.
IDMP pushes further into pharmacovigilance, including the use of IDMP data in Individual Case Safety Reports.
It also goes further than XEVMPD because it encompasses aspects of manufacturing, technical operations,
and chemistry, manufacturing, and control regulatory, including details of the packaged medicinal product
(manufactured product), details of the pack, its components, its ingredients (substances, specified substances,
process steps, grade), manufacturing sites, manufacturing operations authorised at specific sites, details of the
authorising regulator, and much more coding of data in the summary of product characteristics (SmPC). There is
no data that a company should not have, but the main challenges are to identify where the data is to be found and
how it should be collated.
Although the initial
purpose was the
identification of
substances and medicines
for pharmacovigilance
purposes, during the
process of development
of the standards the scope
became significantly
broader, encompassing
many other regulatory-
use cases.

Providing IDMP data for the European Medicines Agency will support master data management for the EU
regulatory network. Master data management involves the establishment of a single, authoritative source for
specific pieces of information. The information will not be data solely for the agency but will be used to facilitate
Pan-European activities and data sharing. The agency is creating master data sets for the following, which will feed
a variety of information systems, as follows.
• Substance
• Product
• Organisation
• Referentials (other vocabularies)
Important Set of Standards with Significant Implications for Industry
IDMP is a set of ﬁve interrelated standards, as deﬁned in table 1.
Table 1. List of IDMP standards
ISO Number Title
ISO 11615:2012 Health informatics—Identification of medicinal products: Data
elements and structures for the unique identification and ex-
change of regulated medicinal product information
change of regulated pharmaceutical product information
change of regulated information on substances
change of regulated information on pharmaceutical dose forms,
units of presentation, routes of administration, and packaging
change of units of measurement
The standards describe the product as authorised and on the market (the medicinal product), and they support
a general concept regarding the administered product (the pharmaceutical product); the substances that are
included in the medicinal product and those that are in contact with it; details about further classification of
substances to identify specific physical forms, specific manufacturers, processes, and grades of materials (specified
substances); and a series of controlled vocabularies to be used in describing products.
Collation and provision of IDMP data will have significant ramifications for industry but also potential
opportunities for the ways companies manage and share data. Overall, IDMP is not data that sits solely in
regulatory affairs, and significant parts of it are—or should be—corporate data. Essentially there is the potential
that IDMP can drive or support master data management initiatives in industry as well as at the European
Medicines Agency. The need to address provision of additional information can be a driver for rationalising the
ways companies manage their own data whereby they establish a single authoritative source that is aligned with
the ISO standards rather than create yet another instance of data that might have to be manipulated and then
maintained independently.

Challenges for most companies will be:
• Locating an appropriate source of the relevant data
• Ensuring that the data aligns with the granularity, vocabularies, and data types of IDMP
• Establishing a mechanism to maintain the data
• Ensuring consistency of the data to be submitted with that which may be identified during pharmacovigilance
or good-manufacturing-practice inspections
It will be desirable to establish a single, authoritative source for each data point, but that may not be achievable,
particularly if an IDMP project is not initiated in time.
With implementation scheduled for 1 July 2016 and given the amount of analysis and preparation needed, it is
advisable to start preparing now, even if we don’t know precisely what the European Medicines Agency will want
until the implementation guides become available, which is not expected to start happening until summer 2015.
It will take time to determine where and how data is to be sourced and to ensure that efficient processes and
technology are in place to support data collection. If an IDMP project is initiated too late, there will be only limited
opportunities to implement strategic solutions, with time only for tactical approaches to be used. Just remember
the problems that were encountered in responding to the XEVMPD requirements, but multiply them several times
for the equivalent of response to IDMP.
The focus so far has been on the requirements for authorised products, but the standards also cover investigation
of medicinal products. Regulators see the importance of continuity of information throughout the life cycle of a
medicine, from clinical trials through marketing and, eventually, discontinuation. However, at this stage there are
neither clear plans for development of implementation guidance nor intended implementation dates for the use
of IDMP in support of investigational products.
A Closer Look at the Standards
Medicinal Product
Medicinal Product Identiﬁer (MPID) (ISO 11615)
This standard defines the data that describes a medicinal product. In this context, a medicinal product is
equivalent to a marketing authorisation whether it is for a one-pack configuration (e.g., as in France) or for many-
pack configurations (e.g., as in the United Kingdom). Although the medicinal product is equivalent to
the authorised product in XEVMPD, the data described is far more extensive. The assignment of the MPID will
be managed regionally by the regulator. The MPID will be in an identifier format different from the product
EV code in XEVMPD.
It is crucial to understand the standard for the medicinal product because that standard will define the majority
of the information that will have to be submitted to any regulator. At its simplest, a medicinal product, as defined
by IDMP, can be regarded as a replacement for the authorised medicinal product (AMP) in XEVMPD. All of the
information contained in the set of data for an AMP can be accommodated in the medicinal product, but there
is also significantly more data defined within the medicinal product. In the MPID model are many mandatory
elements that are beyond the scope of the AMP. However, not all elements are mandatory, because many are
“technically”optional—meaning, the model does not require them to be provided; but in the EU, it is anticipated
that many of these will be required by business rules. At present there is no clarity regarding which optional
elements will be required, because the regional implementation guide is not yet available. In the latter part of
2014, based on analysis under way, the European Medicines Agency and the national competent authorities
should be proposing the mandatory fields in support of particular business processes. The FDA’s position, too,
is unclear, but a likely approach, over time, might be that all data within the scope of IDMP, if already included

in a New Drug Application or Biologics License
Application, will transition from being included
in the dossier in an unstructured way to being
provided in a structured message for IDMP. That
way, the FDA would populate databases with
information provided rather than having to
hunt through dossiers to find related data for
different products.
Figure 1 shows the high-level sections of the
medicinal product. Main points regarding each
of those sections are further described after the
figure.
Medicinal Product, Medicinal Product
Name, and Version
Each medicinal product will have an identifier:
the medicinal product identifier, or MPID. The
MPID will be set at the level of the authorisation.
It will be a code in addition to that of the
authorisation number and will also be different from the product EV code in XEVMPD. More product name parts
will be supported, covering such parts as flavours (e.g., orange flavour), intended use (e.g., hay fever relief), and
target population (e.g., children). IDMP will address those needs in a well-considered way, unlike in XEVMPD,
wherein the June 2014 revised guidance4
makes it clear that in XEVMPD, several of these name parts are to be
included in a single field. In IDMP, they are separated into individual fields. The language for the name will also be
defined and will resolve the problem seen in XEVMPD in countries like Belgium, where different languages have
required different EV codes. Regulated documents will still need to be supplied, but each region will have to define
which specific documents it requires. It may continue to be the SmPC only in the EU, or the requirements could
change. In IDMP, a stricter version control will be applied compared with XEVMPD, with any change made creating
a new version, either major or minor depending on business rules.
Marketing Authorisation
In principle, the information to be provided is similar to the data supplied in XEVMPD—such as marketing
authorisation number, procedure type, procedure number, and marketing authorisation holder (MAH)—but there
are also certain significant differences to address items that aren’t dealt with. Additional information defined
covers the legal status of supply (e.g., prescription or nonprescription) as well as information about the marketing
application, including number and date; information about schedules for the Periodic Safety Update Report;
and information about the marketing status of the product (i.e., marketing start and stop dates). The marketing
status highlights one of the current issues regarding the true requirement for certain fields. In this case, the fields
are technically optional in the model—the reason being that at the beginning of the life of a medicinal product,
it can be authorised but not yet marketed; and so the record has to be able to exist without a marketing status.
The European Medicines Agency may implement a business rule that once a medicinal product is marketed, the
marketing start date must be provided, thereby making this field mandatory. Those are the types of issues being
considered by the agency and the EU regulatory network; the issues will be covered in the regional guidance.
Until that stage, we are left with uncertainty.
The way the MAH, locations, contact details, and so forth are to be provided will be different from the way they’re
provided in XEVMPD. The structure is quite different, but remapping of existing information may be possible. It will
Medicinal
Product
Name
Manufacturer/
Establishment
(Organisation)
Marketing
Authorisation
Packaged
Medicinal
Product
Pharmaceutical
Product
Clinical
Particulars
Medicinal
Product
Version
Figure 1. High-level model of the medicinal product

also be necessary to define the medicines regulatory authority that has authorised the medicinal product. Because
it is intended that regulators share parts of the MPID data to support pharmacovigilance activities, it is considered
important to define which regulator has authorised the product.
Manufacturer/Establishment (Organisation)
This is information not currently included with XEVMPD, but some is already in the regulatory dossier—usually
in the application form and Modules 2 and 3. It defines the manufacturer(s), the contact details, the operations
performed at the defined locations, and the medicines regulatory authority that has granted the authorisation
to conduct the manufacturing operation. The information about the agency may not be in the dossier, but it will
be known within the organisation, although it may not be readily available in a database and so may need to be
collated.
Packaged Medicinal Product
In XEVMPD, the product is defined as an administrable product. This is also included in IDMP, but in addition,
the concept of the packaged medicinal product has been added. It defines each pack size authorised, and an
identifier will be assigned to each package configuration. This move will resolve a major issue in XEVMPD, where
there has been flexibility to define the EV code at either the authorisation level or individual pack sizes within
that authorisation. IDMP separates the two. The European Medicines Agency has already indicated in several
announcements during 2014 that it will be requiring records at this level once IDMP is implemented in 2016.
The standard for packaged medicinal product supports the ability to describe the product in great detail. The
description defines the outer packaging (e.g., carton), intermediate packaging (e.g., cartons within cartons),
containers (e.g., blister packs, vials), and the manufactured product (e.g., tablet, solution) and its ingredients
(substances and specified substances). It can define the components of a container (e.g., bug, cap) and any
device (e.g., administration device) that is included in the pack. It defines the product’s shelf life and storage
conditions, materials (types of glass, plastics, etc.), physical characteristics (e.g., size, colour, shape, image), and
more. For products like powders and solutions for suspension for injection, each vial will be described individually,
with its respective ingredients. The administrable dosage form and its ingredients are described in the section
Pharmaceutical Product.
A significant proportion of this information is likely to be required because the model defines it as mandatory,
but some is defined as optional. Again, the EU guidance will have to define what is required and under which
circumstances. The inclusion of Inspections and Quality as part of the European Medicines Agency’s review of what
information may be required raises the potential that more“optional”information becomes“mandatory.”Some
of the information is likely to be available in the dossier, but some may need to come from the manufacturing
organisation.
Pharmaceutical Product
This section approximates to the product formulation as currently defined in XEVMPD—namely, the administrable
dosage form. In a lot of cases, the administrable dosage form is the same as the manufactured dosage form
(e.g., tablet), so the information will be repeated. However, in cases in which the manufactured dosage form is
different from the administrable dosage form (e.g., powder and solution for injection versus solution for injection),
a different term will be defined. The route of administration is provided along with the set of pharmaceutical
product identifiers (PhPIDs) that are assigned to this pharmaceutical product. (Described in greater detail in the
section, Pharmaceutical Product Identifier).

Clinical Particulars
In XEVMPD, the only clinical
particulars defined are the
indications, coded in the Medical
Dictionary for Regulatory Activities.
A criticism that can be made of this
is that the coding can be imprecise
and not provide any differentiation
between how products are really
used. The approach in IDMP is to
provide the potential to capture a
far wider set of data, associated not
only with the indication but also
with contraindications, including
populations in which the product
is approved for use and other
therapies that may further classify
use. Furthermore, undesirable
effects are to be described along
with any interactions and the
interactant concerned (figure 2).
This provides additional support
for safety analyses. The European
Medicines Agency is already
requiring that up-to-date SmPCs
be provided and that when these
sections change, new versions
are also provided. Provision as
structured data will enhance the
ability to compare across products,
indications, contraindications, and so on.
Some but not all of this information is defined as required within the ISO model, and so, regional guidance will be
needed in order to understand the regulator’s intent. However, the potential impact could be significant. Far more
coding could be required, but the resulting characterisation of the prescribing information would be far more
descriptive and useful than the current coding of indication alone.
In terms of therapeutic indications, together with population specifics and other therapy specifics, the following
examples demonstrate the coverage of these parts of the standard.
• Indication text: As per the SmPC
• Indication as disease/symptom/procedure: Treatment of primary hypertension (as currently in XEVMPD)
• Disease status: Treatment of chronic active liver disease
• Comorbidity: Treatment of pneumocystitis pneumonia in AIDS
• Intended effect: Passive immunisation against rabies infection
• Timing/duration: Prevention of atherothrombotic events in patients with ischaemic stroke (from 7 days until
6 months)
• Age: Indicated in paediatric patients
• Age range: Adults older than 35 years with primary hyperlipidaemia
• Gender: For the treatment of men with prostate cancer
Interactions Interactant
Undesirable
Effects
ContraindicationsTherapeutic
Indications
Other Therapy
Specifics
Population
Specfics
Clinical
Particulars
Medicinal
Product
Figure 2. Intermediate-level model of clinical particulars

• Race: e.g., Caucasian, Afro-Caribbean, Hispanic (although this is rarely applicable to indications but often
applicable to contraindications)
• Health status: Can be used during lactation
• Therapy relationship: Following prior treatment with proton pump inhibitors
• Medication: Prevention of atherothrombotic events in combination with acetylsalicylic acid
The SmPC is a complex document, and coding of the clinical particulars has the potential to involve a significant
amount of work. For many products, the SmPC changes on a frequent basis as the use of the medicine grows,
new indications get defined, undesirable effects and contraindications get identified, and so forth; and so the
maintenance of this information will also be a significant activity.
Ingredients and Substances
For both the packaged medicinal product and the pharmaceutical product, each ingredient will have to be
identified and its role defined. This task is likely to go beyond just defining an ingredient as, say, active ingredient,
or adjuvant, or excipient. For excipients, the purpose in the product is likely to need definition (e.g., preservative,
flavouring, mechanical ingredient). Depending on what rules are to be defined in the implementation guidance,
this could be either as general substance IDs or as more-precise specified substance IDs. As mentioned earlier,
the specified substance could define the physical characteristics (e.g., crystalline or amorphous), the general
manufacturing method (e.g., synthetic, extractive, recombinant), the specific manufacturer (e.g., Manufacturer A
or Manufacturer B), and/or the grade of material used (e.g., EP or USP).
One of the advantages of defining the active ingredient and its strength by use of the IDMP model is that the
IDMP model makes clear what substance is being defined and what its strength is. In IDMP, it is possible to define
not only the substance and its strength but also the reference substance and the reference strength. In XEVMPD,
it is possible to define only one, which causes confusion as to whether to define the base, salt, or active moiety
and then to have the correct strength according to the SmPC. Clearer guidance has been provided in more-recent
XEVMPD guidance, but because of XEVMPD’s design, there are significant constraints regarding what can be
achieved, and lack of clarity may well persist. In IDMP, however—when applicable—there may be a requirement
to define both: for example, the salt and its strength and the base and its strength. The final rules are yet to be
defined, but the potential is stated.
The substance IDs will not be the same codes as in XEVMPD but may well be the Unique Ingredient Identifier
(UNII) codes the FDA currently uses, but that is yet to be confirmed. The European Medicines Agency is currently
assessing (1) whether to use the FDA’s new Substance Registration System (Global Ingredient Archival System, or
GInAS), which will be compliant with the ISO 11238 standard for substances, and (2) whether the FDA’s UNII codes
should be the European codes as well. A decision is expected later in 2014.
From an industry standpoint, it would be much simpler if the agency committed to a global process and a
global identifier; otherwise, there will have to be parallel activities on both sides of the Atlantic. However, the
FDA’s substance registry is not comprehensive, and although most chemical and biological active ingredients
and excipients are included, the registry does not yet cover such substances as herbals and homeopathics, which
are required to be included for XEVMPD. Nor does it contain any specified substances, which are likely to play
significant roles for many types of product in describing a product’s constituent ingredients. It is clear that a great
amount of work will be required to create a globally recognised, controlled vocabulary for substances—one that
holds all of the data defined in the standard for substances (ISO 11238). If the Structured Substance Information
had progressed in XEVMPD, it would have been the responsibility of all MAHs to provide detailed information
for every substance they used in their products. That should not be the case with IDMP, and only a single record
will be created. Many substances may already be defined adequately in the databases of the FDA, the Medicines
Evaluation Board, and Germany’s Federal Institute for Drugs and Medical Devices; and it is intended that a global
pool of substance data be created from existing sources—although the European Medicines Agency has yet to

commit to this and will not do so until its analysis is complete. That’s why it’s not yet clear where responsibility
would lie for substances not included in any database or where data needs to be augmented to bring it up to the
required standard. Will the burden fall on industry? Or will it be the responsibility of one or more regulators?
Relationship between XEVMPD and IDMP
As discussed in this paper, the scope of data covered by IDMP is significantly larger than that covered by XEVMPD.
Figure 3 visualises the degree to which information in IDMP is either essentially the same as XEVMPD, or is similar
but may have some more fields, or is completely new data not previously covered at all in XEVMPD. Even when
the data are the same or similar, there are the possibilities that they will be at different levels of granularity or that
a different controlled vocabulary will have to be used. There is no doubt that some data can be mapped easily
between the two, but there is still much that will require some intervention to realign. As for the new information,
sources for it would have to be identified within an organisation.
Figure 3. Scope of IDMP data compared with XEVMPD data
Manufacturing
OperationNEW
Medicines
Regulatory
Agency
NEW
Marketing
Authorisation
Holder
SAME
Marketing
Authorisation
Procedure
MORE
Periodic Safety
Update Report
Submission
NEW
Marketing
StatusNEW
Marketing
Authorisation
Application
MORE
Batch
Identifier
NEW Package Item
(Container) NEW
Country/
Language
Medicinal
Product
Classification
Route of
Administration SAME
PhPID
Set NEW
Pharmaceutical
Product
Characteristics NEW
Ingredients SAME
Strength SAME
Substance SAME
Reference
Strength
NEW
Specified
Substance MORE
Interactant NEWInteractions NEW
Undesirable
Effects NEW
Contraindications NEW
Population
Specifics NEW
Therapeutic
Indication MORE
Other Therapy
Specifics NEW
Device
Nomencalture
NEW
Device MORE
Manufactured
Item NEWShelf Life/
StorageNEW
Data Carrier
IdentifierNEW
Physical
Characteristics
NEW
Package
(Component)
NEW
Device Batch
IdentificationNEW
Other
Characteristics NEW
NEW MORE
Medicinal
Product
Name
Manufacturer/
Establishment
(Organisation)
Packaged
Medicinal
Product
MORE
Marketing
Authorisation
MORE
Pharmaceutical
Product
MORE
Clinical
Particulars
MORE
Medicinal
Product
NEW
Regulated
DocumentSAME
Version
NEW
NEW

Pharmaceutical Product Identifier (ISO 11616):
This standard defines the concept of a pharmaceutical product—an issue not addressed in XEVMPD. The same
PhPIDs will be assigned to all medicinal products that have the same characteristics—including substance, dosage
form, and strength—regardless of the country they were authorised in (figure 4). The PhPID is key to improving
pharmacovigilance by enabling greater confidence in data that comes from other regulators. This can then be used
to create larger sets of product data to be used for signal detection. It is yet to be decided whether the PhPID or,
more correctly, a set of PhPIDs will be assigned by regulators or MAHs, because it is to be created via an algorithm
based on component identifiers. The identifier assigned will be the same globally because it will be based on
the substance, strength, and dosage form, all of which should be globally applicable identifiers—subject to the
European Medicines Agency’s agreement on the substance ID.
Figure 4. Relationship between MPID and PhPID
Common PhPID Set
Japan
Branded
Product A
MPID1
USA
Branded
Product B
MPID2
France
Branded
Generic C
MPID3
France
Generic D
MPID4
Germany
Branded
Generic E
MPID5
Germany
Branded
Generic F
MPID6
Canada
Branded
Generic G
MPID7
Pharmaceutical
Product
Substance Identifier and Specified Substance Identifiers, ISO 11238
This standard describes the data for uniquely defining substances such as active ingredients, adjuvants, and
excipients but also packaging materials, even though likely to be only those that are in contact with the drug.
The standard also defines data that can further describe substances in a variety of different ways as specified
substances. Specified substances can define substances from different manufacturers, with different grades, and
can support high-level and detailed manufacturing-process descriptions as well as multiconstituent substances
such as colourants, flavours, and culture media. The Structured Substance Information, initially defined as part of
XEVMPD but later withdrawn, was based on this standard. The identifiers will be assigned globally by regulators—
subject to the European Medicines Agency’s agreement.
It is clear that to be able to classify some types of substances adequately and so differentiate between them, the
use of the specified substances will be important. For many herbals, polymers, and advanced therapy products,
the detail to be found in the specified substances part of the standard will be necessary in order to uniquely
differentiate between substances that at the substance level are essentially similar but may have very different
factors that could affect safety—for example, solvents used for extraction. Simple chemical/structural definition is
insufficient to define and differentiate such substances.
Many challenges lie ahead before achievement of implementation of the substance standard on a global scale, but
they are not insurmountable.

Control Vocabularies, ISO 11239
This standard defines how controlled vocabularies are to be created to cover routes of administration,
pharmaceutical dosage forms, units of presentation, and packaging. These will be global vocabularies, and existing
regional vocabularies will have to be mapped to them. There may be differences between the vocabularies used
for XEVMPD and for IDMP, but there is the potential that the European Directorate for the Quality of Medicines &
HealthCare’s (EDQM’s) standard terms used in XEVMPD will become the terms for IDMP. That decision has yet to be
made. Packaging will be a new controlled vocabulary, because nothing similar exists at present.
Units of Measurement, ISO 11240
This standard stipulates that an existing standard for units of measurement—the Unified Code for Units of
Measure (UCUM) standard—will be used to define the strength of medicinal products. This standard is already
used in XEVMPD, although some terms used provisionally in XEVMPD need to be included formally in the UCUM
standard.
Implementation Plans and Needs
The implementation date for IDMP in the EU has been defined as 1 July 2016. At
present, it has not been stated what that date refers to precisely. In July 2011,
when the European Medicines Agency announced the requirements for XEVMPD,
reference was made to implementation of IDMP (at that stage, 1 January 2015)
but that it would be a transitional process taking place over a 12-month period,
beginning with new products submitted in IDMP format, changes to existing
product records necessitating conversion to IDMP, and any remaining records
migrated at the end of the 12 months. There is no guarantee that this will be the
same from July 2016, but a transition period is expected.
To meet that deadline much needs to occur, but there is significant commitment
from other regulators and the pertinent ISO technical committee to facilitate
achievement of the date.
Implementation by the FDA is not defined by legislation, but the agency plans to
implement at an appropriate point, with evolution of its Structured Product Labeling (SPL) requirements. The FDA’s
plans would need to be formally announced for comment in the Federal Register. However, the FDA’s long-term
goal is for as much data as possible to be structured within IDMP rather than in an unstructured manner in the
submission dossier.
The Swiss, Canadian, and Japanese regulators are also contributing to the implementation activities. Beyond the
International Conference on Harmonisation (ICH) group of countries, Australia, Russia, and Iran have nominated
or will be nominating experts for development of the implementation guide for substances, thereby suggesting
widening interest in the standards as they are progressed.
It is not possible to take the standards and implement them. Several supportive items, described as follows, are
required, and either (1) these are in the process of being progressed or (2) there are dependencies, which means
they have not yet started.
Common implementation (ISO) guidance: This guidance is designed to provide a common interpretation of
the IDMP standards so that all fields will be used similarly whenever implemented. Although initiated within ICH,
this activity has passed to ISO Technical Committee 215, Working Group 6, which is the group that developed the
standards. Work on the implementation guide for substances (ISO 11238) has been initiated and the first ballot
Implementation by the
FDA is not defined by
legislation, but the agency
plans to implement at an
appropriate point, with
evolution of its Structured
Product Labeling
requirements. The FDA’s
plans would need to be
formally announced for
comment in the Federal
Register.

undertaken, which elicited from industry, regulators, and software vendors a large number of comments that need
to be addressed. In addition, the work being undertaken by several regulators in the GInAS project has identified
a number of further implementation needs. A tentative date for release of the ISO implementation guide for
substances is July 2015.
Three other implementation guides will be needed: one each for the medicinal product (ISO 11615), the
pharmaceutical product (ISO 11616), and the set of vocabularies (ISO 11239). Work has not started on these, but
the first ballot is expected by the end of 2014, with publication provisionally targeting December 2015. There are
no plans to produce an implementation guide for the units of measurement standard (ISO 11240), because this is
an existing standard.
Messages: As with XEVMPD, in which the eXtended EudraVigilance Product Report Message is used as a message
from the MAH to the European Medicines Agency, so messages are needed to be able to send and receive
acknowledgements between the MAH and regulators, potentially between regulators, and between regulators
and the public. These will be messages that apply the Health Level 7 (HL7) standard, probably as part of an
extension to the SPL standard already used by the FDA. Proposals to extend the SPL scope will be made to the
appropriate HL7 committee before the end of 2014.
Regional implementation guidance: The common implementation guidance does not state specifically
what each individual region requires, and so for each implementation, it will be necessary to define some
specific, augmented regional implementation guidance that will identify, for example, exactly what information
will be required, under which circumstances, how it will be submitted, and so on—just as the XEVMPD guidance
does now.
Each region may choose to require different data (although there will be a common, core set of data that all
will require), so implementation in the EU could be significantly different from implementation in the United
States. The European Medicines Agency has determined that only two regional guides will be required: one for
the medicinal product and one for the substances. Because the pharmaceutical product and the vocabularies
for dosage forms will have the same values globally, there will be no need for regional guidance. To publish the
regional guidance in time for 1 July 2016, it will be necessary to develop these guides in parallel with the ISO
guides. Initial plans stipulate that a good draft of the ISO guide will be used as the basis on which the EU guides
get drafted. Drafts will have to be circulated for comment, and it may be necessary to treat a final draft as the
basis for implementation. The earliest date on which the EU substance implementation guide would be published
is July 2015; the earliest for the medicinal product guide would be December 2015, only seven months before the
implementation date (table 2).
Maintenance organisations: Organisations have to be identified for the creation and maintenance of controlled
vocabularies and identifiers. It will involve the regulators, which will be issuing regionally defined controlled
vocabularies and identifiers but which are working collectively where the controlled vocabularies and identifiers
are to be global. Certain specific standards development organisations and other institutes, such as EDQM, will
have to be involved as well. The regulators are continuing to work in a group known as IDMP External Group on
collective activities in support of implementation. However, each regulator will have to make decisions about
who will act as its maintenance organisations. It is hoped that regulators will each select the same maintenance
organisation, but it is possible that they may select different ones.
For the success of the implementation, it is essential that all of the organisations involved work to defined
processes and quality standards. To achieve that goal, ISO is developing the Core Principles for Maintenance of
Identifiers and Terms, which will set the quality standards expected.

Overall Plans andTimelines
The European Medicines Agency is in the process of developing an implementation road map for IDMP. A
precursor to that process has been ongoing work with the EU regulatory network to determine which fields will
be required and for what purpose. It is likely to be late-third-quarter or early-fourth-quarter 2014 before the
agency makes a proposal to industry via the Article 57 Implementation Working Group. Much negotiation may be
necessary before a firm road map is agreed on.
As mentioned previously, development of the ISO implementation guides has started for one standard but needs
to be started for the other three standards. Additionally, two EU guides need to be produced. Table 2 outlines the
potential dates, if indeed the agency runs development of the EU guide in parallel.
The most crucial implementation required is for the medicinal product, because that implementation will cover
the vast majority of data needing submission. However, this is on the tightest timeline, and it is necessary to
provide as firm a foundation as possible for implementation planning—and as soon as possible. Good drafts made
available throughout 2015 will prove very beneficial. Table 2 identifies the anticipated implementation guides and
the target or potential publication dates.
Table 2. IDMP implementation guides
IDMP Standard ISO implementation guide
(target publication date)
Regional implementation guide
(potential earliest
publication date)
ISO 11238: Substances Yes
(June 2015)
Yes
(July 2015)
ISO 11239: Vocabularies Yes
(December 2015)
No
ISO 11240: Units of Measurement No No
ISO 11616: Pharmaceutical Product Yes
(December 2015)
No
ISO 11615: Medicinal Product Yes
(December 2015)
Yes
(December 2015)
Moving Ahead for Industry
Several potential options are available to industry for planning to move ahead with IDMP. They can be summarised
as follows.
• Ignore the standards and the implementation for now, bearing in mind that they won’t go away. At some
point, they’ll need to be addressed to maintain compliance with regulations.
• Wait until the guides have been released, though it may prove too late to approach the solutions in a strategic
manner. Potential benefits will be missed, and companies will be left with just the cost of compliance.
• Start now, based on what is known and what can be predicted, to assess, monitor, and plan. Doing so offers
the opportunity to look for internal benefits and efficiencies such as applying the IDMP standards internally
and establishing a single, authoritative source of data for multiple purposes. However, this would require the
application of significant resources and at a time when much work is required for the updating of XEVMPD
data and the implementation of maintenance processes. It may be difficult to progress both at once.

The following points may be considered industry current best practice to move ahead with IDMP projects.
• Recognise the need to address IDMP because typically, regulatory affairs and/or regulatory information
technology is pivotal in initiating it.
• Gain sufficient understanding of the standards (to a level beyond what this paper provides) by at least a small
group to determine the implications of IDMP implementation for the company.
• Obtain sufficient sponsorship to convene a group that together will develop a vision and strategy for IDMP
assessment and implementation (often called a preproject).
• Develop a vision and strategy and seek endorsement from an executive committee with a broad base of
coverage because management of the data is—or should be—considered a corporate responsibility.
• Establish sponsorship for the main project, typically regulatory led but with adequate corporate-level
commitment to provide the necessary resources.
• Broaden the base of understanding of the standards within the organisation.
• Conduct an analysis of where the data resides—or doesn’t—in the company and how it can be brought
together, considering the challenges and opportunities that that may pose.
• Establish the strategic approach to data management in the forms of:
− Regulatory compliance only for Europe
− Regulatory compliance for global markets
− Compliance in the context of master data management
• Establish and initiate implementation plans.
• Plan to fine-tune strategy as guidance becomes available.
• Influence guidance by providing comments based on detailed assessment of the implications to the
company—not just on theory.
• Influence vendors of RIM systems in the development of their own tools and strategies.
In essence, this process can be summed up as, plan now so that the company can be in a position to act. The
process should not be limited to companies that have their own RIM systems at present. Even though data entry
via an updated European Medicines Agency Web-based tool will no doubt remain possible, the anticipated scope
of the required data is likely to be on a scale that will stretch many companies’abilities to effectively manage
their data via, for example, spreadsheets. Consideration should be given to the tools necessary to manage the
information internally as well as to deliver it to regulators.
IDMP will be upon us soon. The more time a company takes to prepare and the sooner those preparations start,
the better position that company will be in to respond.
__________________________________
References
1. Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of
pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of
the Council and Directive.
2. ISO/HL7 27953-2:2011 Health informatics -- Individual case safety reports (ICSRs) in pharmacovigilance -- Part
2: Human pharmaceutical reporting requirements for ICSR; http://www.iso.org/iso/home/store/catalogue_tc/
catalogue_detail.htm?csnumber=53825.
3. Personalising Health and Care: eHealth interoperability; http://ec.europa.eu/research/participants/portal/
desktop/en/opportunities/h2020/topics/2257-phc-34-2014.html.
4. Detailed guidance on the electronic submission of information on medicinal products for human use by
marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second
subparagraph of Regulation (EC) No. 726/2004: Chapter 3.II: Extended EudraVigilance product report message
(XEVPRM) user guidance; http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/03/
WC500123681.pdf.

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