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Comparison of Clinical Trial Application requirement of India, USA and Europe.
1. Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
EXPERIMENT NO.: DATE:
AIM: Comparison of Clinical Trial Application requirement of India, USA and
Europe.
REFERENCES:
1) http://cdsco.nic.in/CDSCO-GuidanceForIndustry.pdf
2) http://www.slideshare.net/RETIRE/clinical-trial-requirements-us-vs-eusimilarities-
and-differences
3) http://blog.worksure.org/clinical-trial-application-cta-submission-in-india/
4) http://www.amarexcro.com/articles/docs/RAPS_Focus_Practical_Feb2009.pdf
COMPARISION:
PARAMETERS EUROPE USA INDIA
1. LEGAL FRAME
WORK
European Union EU
Directives
applicable to all
members
National laws apply
Legal representative
required
Federal statutes
and regulations
applicable to all 50
states
Individual state
laws apply
Authorized
representative
CDSCO under the
aegis of Ministry
of Health &
Family Welfare
have the duty of
regulating and
ensuring the
quality of
medicines and
pharmaceuticals
under the Drugs &
Cosmetic Act.
2. CLINICAL
TRIAL
APPLICATION
CTA written
approval required
Approval timeframe
varies
IND written
approval not
required to
proceed
Form 44 is an
application made
for grant of
permission to
2. Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
Annual safety report
only required
Format CTD paper
or electronic
National CTA fees
may apply
commence CT
May proceed 30-
days after FDA
receives IND
unless notified
otherwise
IND annual report
required
Format paper or
electronic, US
format or CTD
No fees Required
import or
manufacture a new
drug or to
undertake Clinical
Trial.
documents
pertaining to
chemical and
pharmaceutical
information,
animal
pharmacology,
toxicology data
and clinical
pharmacology
data.
Investigator’s
Brochure, trial
protocol, case
report form,
informed consent
form, patient
information sheet,
investigator’s
undertaking and
IEC approvals (if
obtained during
review process).
Regulatory status
of the trial in other
participating
countries also
needs to be
3. Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
reported.
Fees for phase I
application is Rs
50000
Fees for phase II
and III application
is 25000
3. INSTITUTIONAL
REVIEW BOARD
EC approval
required
ECs appointed or
authorized by States
IRB approval
required
IRB registration
required
DCGI approval
IRB / EC approval
required
4. FORM/S
REQUIRED
Statement of
Investigator not
required by member
states
Form FDA 1572 is
required to be
signed by the PI, if
study is conducted
in US and
submitted to IND
Form no: 44 is
required for
application of
clinical trial.
5. RECORD
RETENTION
Essential Document
Record includes
CRF, excluding
medical records: ≥ 5
years
≥ 15 years or CT
discontinuation if
data used to support
a marketing
application
Record retention 2
years after
marketing
application is
approved
Record retention 2
years after last
shipment and
delivery of IMP if
marketing
application is not
approved.
Retention of
records 3 years
after marketing
application is
approved
4. Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
6. INVESTIGATION
AL MEDICINAL
PRODUCT
REQUIREMENTS
Label must comply
with Annex 13 of
EU Directive
2001/83/EC
Language
requirements varies
between member
states
Sponsor is
responsible for
destruction of
unused and/or
returned IMP
Label must be in
English, except for
Puerto Rico
The following
statement is
required:
“Caution: New
Drug Limited by
Federal (or United
States) law to
investigational
use”
Study code
API and
formulation
Batch no. , expiry
date and retest
date
Dosage
Direction of use
Manufactured by
“FOR CLINICAL
TRIAL USE
ONlLY”
7. ADVERSE
EVENT
REPORTING
Review and
monitors the safety
information of IMPs
used in clinical
trials conducted in
their respective
territories through
the use of the
EudraVigilance
Clinical Trial
module (EVCTM)
Report to the
sponsor all serious
adverse events
immediately
Required to report
to the Sponsor any
adverse events
caused by or
probably caused
by IMP
Notify FDA and
all participating
investigators in a
written IND safety
report of: Any
adverse experience
associated with the
use of the drug
that is both serious
and unexpected.
Required to report
unexpected fatal
or life threatening
Upon the
discovery of any
injury or death
related to a clinical
trial, sponsors will
now be required to
inform the DCGI
within 24 hours.
Following this
reporting line,
relevant clinical
trial stakeholders
will be required to
submit individual
reports for
scrutiny by an
independent
review committee,
due to be created
5. Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
experiences
ASAP, but not
later than 7 days;
Follow-up reports
ASAP but no later
than 15 days of
receipt of new
information
by the DCGI.
8. REGULATORY
COMPLIANCE
covered under
Article 15 of
Directive
2001/20/EC CA
responsible for
implementing
provisions for the
suspension of a CT
conducting
inspections and
verifying
compliance
Inspection reports
may also be made
available to
Sponsor, EC,
EMEA and other
member states Must
comply with Good
Distribution
Practices (GDPs)
and Good
Laboratory
All clinical trials
must comply with
21 CFR Parts 50,
54, 56, 58 and 312
Phase 1 IMPs are
exempt from
certain parts of 21
CFR Part 211,
unless the clinical
trial involves a
marketed drug
product or one that
was manufactured
in a Phase 2 and/or
3 study
Indian GCP states
that if the sponsor
is a foreign
company,
organization or
person(s) – it shall
appoint a local
representative
or CRO to
fulfill the
appropriate
local
responsibilities
as governed
by the Indian
regulations.
6. Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
Practices (GLPs)
no comparable EU
regulation specific
to Phase 1 CGMPs
(Annex 13 guideline
provides flexibility
dependent upon the
stage of
development of the
product)