3. INTRODUCTION
International Conference on Harmonization of
Technical Requirements for Registration of
Pharmaceuticals for Human Use.
Agreement between Europe, Japan and US regulatory
Authorities.
Joint initiative involving both Regulators and Industry
as equal partners.
Main focus on Technical Requirements for medicinal
products containing new drugs.
Tuesday, October 10, 2017 3
Ref.: Forensic Pharmacy by B.S. Kuchekar
Pg. No. 16.16 – 16.25
4. Establishment of ICH
• The International
Conference on
Harmonization of Technical
Requirements for the
Registration of
Pharmaceuticals for Human
Use (ICH) was established
in 1990 as a tripartite
venture representing
regulatory bodies and
research-based industry.
Tuesday, October 10, 2017 4
Ref.:
http://apps.who.int/medicinedocs/en/d
/Jh2993e/4.html
5. INTRODUCTION (Contd.)
Achieve greater harmonization
in interpretation and
application of Technical
guidelines.
More economical use of
Human, Animal and Material
Sources.
Elimination of unnecessary
delay in global development.
Availability of safe, quality and
efficacious new medicines.
Promote patient health.
Tuesday, October 10, 2017 5Ref.: Forensic Pharmacy by B.S. Kuchekar
6. MISSION
Tuesday, October 10, 2017 6
Make recommendations towards
achieving greater harmonization
in Interpretation and Application
of Technical Guidelines and
Requirements for
Pharmaceutical Product
Registration.
Ref.:
https://www.slideshare.net/naveenniper
/ich-guidelines-12769383
7. ICH Organizational Structure
The ICH structure consists of the
• ICH Steering Committee
• Global Cooperation Group (GCG)
• ICH MedDRA Management Board
• ICH Coordinators,
• ICH Secretariat and
• ICH Working Groups.
Tuesday, October 10, 2017
Ref.:
https://www.slideshare.net/mdgayas70/
ich-guidelines-seminar
7
8. Global Cooperation Group
(GCG)
• The ICH Global Cooperation Group (GCG)
was formed on March 11, 1999, as a
subcommittee of the ICH Steering Committee.
• It is made up of one representative from each
of the six parties on the ICH Steering
Committee, plus the IFPMA.
• The ICH Observers, WHO, Canada and EFTA
are also part of the GCG.
Tuesday, October 10, 2017
Ref.:
https://www.slideshare.net/mdgayas70/
ich-guidelines-seminar
8
9. ICH parties
• EU
• EFPIA (European federation of pharmaceutical industries’ associations)
• MHLW (Ministry of health, Labor and welfare, Japan)
• JPMA (Japan Pharmaceuticals manufacturers Association)
• US FDA
• PhRMA (The Pharmaceutical Research and Manufacturers of America)
• Observers : WHO, TPP(Canada)
• International Federation of Pharmaceutical
Manufacturer’s Association
6 Parties of ICH
Tuesday, October 10, 2017
Ref.:
https://www.slideshare.net/mdgayas70/
ich-guidelines-seminar
9
11. INTERNATIONAL
HARMONIZATION:
The process of standardizing laws, regulations and
practices to facilitate the expansion, fairness and
efficiencies of competing in globalized economy.
Tuesday, October 10, 2017 11
13. HARMONIZATION EFFORTS
ICH 2009-2010
1st ICH Guideline on Gene Therapy
Progress on interface between ICH and Standards
Development Organization.
Expansion of Global Cooperation Group
Global Harmonization Task Force
Efforts to harmonize medical device regulatory
requirements and terminology
Asia Pacific Economic Cooperation
Life Science Innovation Forum 2009
Pharmaceutical Inspection Cooperation Scheme
Tuesday, October 10, 2017 13
Ref.:
https://www.slideshare.net/NailaKanwal
/harmonization-and-its-impact-theme2
14. Positive impacts of Harmonization
Established a set of standards
for the manufacturing
processes of new drugs.
Agree on one set of scientific
rules to running clinical trials.
Reducing Expenses (In terms
of Research animals and
human testing).
Faster Approvals
Harmonized documentation.
Ensured similar application
process for drug approval in
all countries.
Ensured that research
findings from one member
country will be accepted by
all other countries (With
some exceptions)
Provision of quality drugs
with Efficacy.
Tuesday, October 10, 2017 14
Ref.:
https://www.slideshare.net/NailaKanwal
/harmonization-and-its-impact-theme2
15. Drawbacks of Harmonization
Public accountability is missing.
Reduced the safety tests with
respect to trials
Potentially weaken the public
health.
Limit Competition.
Raised the cost of medicine.
Threatened the production of
inexpensive generic drugs.Tuesday, October 10, 2017 15
Ref.:
https://www.slideshare.net/NailaKanwal
/harmonization-and-its-impact-theme2
20. EFFICACY GUIDELINES
• E1: CLINICAL SAFETY FOR
DRUGS USED IN LONG-
TERM TREATMENT
• E2A – E2F:
PHARMACOVIGILANCE
• E3: CLINICAL STUDY
REPORTS
• E4: DOSE RESPONSE
STUDIES
• E5: ETHNIC FACTORS IN
THE ACCEPTABILITY OF
FOREIGN CLINICAL DATA
• E6: GOOD CLINICAL
PRACTICE
• E7: CLINICAL TRIALS IN
GERIATRIC POPULATION
• E8: GENERAL
CONSIDEARTIONS FOR
CLINICAL TRIALS
• E9: STATISTICAL
PRINCIPLES FOR CLINICAL
TRIALS
• E10: CHOICE OF CONTROL
GROUP IN CLINICAL
TRIALS
• E11: CLINICAL TRIALS IN
PEDIATRIC POPULATION
Tuesday, October 10, 2017 20
Ref.:
http://www.ich.org/products/guidelines
/efficacy/article/efficacy-guidelines.html
21. EFFICACY GUIDELINES
(CONTD.)
• E12: CLINICAL
EVALUATION BY
THERAPEUTIC
CATEGORY
• E14: CLINICAL
EVALUATION OF QT
• E15: DEFINITIONS IN
PHARMCOGENETICS /
PHARMACOGENOMICS
• E16: QUALIFICTION OF
GENOMIC BIOMARKERS
• E17: MULTI-REGIONAL
CLINICAL TRIALS
• E18: GENOMIC
SAMPLING
Tuesday, October 10, 2017 21
Ref.:
http://www.ich.org/products/guidelines
/efficacy/article/efficacy-guidelines.html
25. Tuesday, October 10, 2017 25
Issued in Nov. 2012
Development and Manufacture of Drug Substances
Quality Principles for Manufacturing Process
Development:
1. Drug-substance quality linked to drug product
2. Process-development tools
3. Approaches to development
4. Drug-substance CQAs
5. Linking material attributes and process parameters to drug
substance CQAs
6. Design space Ref.:
http://www.pharmtech.com/understand
ing-ich-q11-fdas-guidance-development-
26. Tuesday, October 10, 2017 26
DOCUMENTATION REQUIRED:
An overall summary of the development process including: CQAs;
description of design stages; description of material attributes;
description of process parameters; and description and
development of design spaces should be provided.
CQAs of the drug substance shall be listed.
A detailed discussion of the manufacturing process history needs to
be provided.
Manufacturing development studies, including risk assessments
employed in support of commercial development, including the
control strategy, must be provided.
(CONTD.)
Ref.:
http://www.pharmtech.com/understand
ing-ich-q11-fdas-guidance-development-
27. Tuesday, October 10, 2017 27
DESCRIPTION OF PROCESS & PROCESS
CONTROL EMPLYOED IN MANUFACTURING:
Material-selection process
Selection of starting materials for synthetic drug
substances
Selection of starting materials for semisynthetic drug
substances
The selection of source and starting materials for
biotechnical/biological drug substances
(CONTD.)
Ref.:
http://www.pharmtech.com/understand
ing-ich-q11-fdas-guidance-development-
28. Tuesday, October 10, 2017 28
DESCRIPTION OF PROCESS & PROCESS
CONTROL EMPLYOED IN MANUFACTURING:
(CONTD.)
Control strategy:
Controls employed for raw
materials
Controls associated with
the design manufacturing
process
In-process controls (i.e.,
testing and process control
points)
Controls placed on the drug
substance (e.g., release
testing)
Submission of relevant
information:
Description of manufacturing-
process controls
Controls employed for
materials
Controls for identified critical
process steps
Controls for the drug substance
Container closure systemsRef.:
http://www.pharmtech.com/understand
ing-ich-q11-fdas-guidance-development-
29. Tuesday, October 10, 2017 29
PROCESS VALIDATION:
EMPLOYMENT OF CTD FORMAT FOR INFORMATION
SUBMISSION:
LIFECYCLE MANAGEMENT:
Process-development activities
Technology-transfer activities
Process-validation studies
Change-management activities
(CONTD.)
Ref.:
http://www.pharmtech.com/understand
ing-ich-q11-fdas-guidance-development-
31. COMMON TECHNICAL
DOCUMENT
• M4 GUDELINE (July 2003)
• The agreement to assemble all the Quality, Safety
and Efficacy information in a common format
• Organized into 5 modules
• Module 1 is region specific and Modules 2, 3, 4
and 5 are intended to be common for all regions
Tuesday, October 10, 2017 31
Ref.:
http://www.ich.org/products/ctd.html