IND
COMPARISON OF REGULATORY REQUIREMENT FOR IND APPLICATION:
US
1. One Regulatory authority –
FDA- CDER/CBER
2. Investigational New Drug
(IND) Application
3. Follow Code of Federal
Regulations (CFR)-
21 CFR 312.20-38
4. Approvals required
-Ethics Committee
-FDA
5. ------
6. US “Resident US Agent”
required by non-US sponsors in
US
7.Insurance of subjects is not
mandatory for the trial.
EU INDIA
1. Central Regulatory authority - 1. One Regulatory Authority - DCGI
EMEA (Europe Medical Agency) &
Many CAs (Competent
Authorities)
[UK- MHRA: Medicines and
Healthcare products Regulatory
agency]
2. Clinical trial authorization 2. Application for permission to
(CTA) Application import/manufacture New Drug or to
undertake Clinical Trial -Form 44
3.Follow EU Clinical Trials 3. Follow Schedule Y under Drugs
Directive – & Cosmetics Act, 1940 (DCA)
EU Directive 2001/20/EC
which came in to force on 1/05/04
4.Approvals required 4. Approvals required
-R&D Committee -Ethics Committee
-DCGI
-Research Ethics Committee
-Regulatory Authority/Competent
Authority
5. EUDRACT database –Apply for 5. ------
EUDRACT number is must.
6.Sponsor EU Legal 6. ---------
Representative
7.Insurance of subjects is 7.Insurance not mandatory
mandatory for the trial.
8.Trials conducted in normal 8.Trials conducted in normal 8.Trials conducted in normal
volunteers require government volunteers do not require volunteers require approval
approval approval.

9. -------- 9.If a randomized controlled trial 9. -------

then register with the database of
randomized controlled trials and
obtain an ISRCTN
(International Standard of
Randomised Controlled Trial
Number) & a fee to be paid.

10. There are four types of IND-

Investigational, Treatment and ---------- ---------
Emergency IND.

11.IRBs give 11.Some ECs give opinions only 11. -------

approval/disapproval/approval
with revision.

12.Sponsor has limited 12.Sponsor has free 12. -----

communication with IRB. communication with EC

13.One-part consent-contains all 13.Two-part consent-Plain

information for subject language information sheet and
consent to participate

14.Subjects are also given a copy ------- ---------

of consent

15. Investigational New Drug 15. Clinical Trial Authorization 15.Sch Y- Form 44
(IND)-Form 1571 (CTA) Application-Annex 1

16. IND Application has to be 16. One paper CTA & an 16.Paper Application only
submitted in triplet-One original electronic version XML file to be
and two photocopies. submitted to CA; supporting docs
can be submitted electronically.
17. IND Application:
A. Cover sheet (Form FDA–1571) -Cover letter, confirmation of
B. A table of contents.
C. Introductory statement
D. General Investigational plan
E. Investigator’s brochure.
F. Protocols
-Study protocol
-Investigator data
-Facilities data
-IRB data
G. Chemistry, manufacturing, and
control information-
Composition, stability, controls
H. Pharmacology and toxicology
information-
Pre clinical data
18. Previous human
experience with the
investigational drug.
J. Additional information.
18.Timelines:
FDA sets a timeline for
17. Clinical Trial Authorization
application:
EudraCT number & authorization
for applicant to act for Sponsor
-Application form (Annex 1) & fee
A.Trial identification (EudraCT
number)
18. Sponsor id.
18. Applicant id.
18. Info.on the IMPs –IMPD
18. Info. On the Placebos
18. Sites responsible for IMP
release
G. General Info. On the trial
18. Pop. Of trial subjects
18. Proposed sites in the
Member
State
18. Ethics Committee/MS
Competent Authority
K. Check list
-IMP Dossier (IMPD)
-Accompanying documents
• Investigator Brochure
• EC opinion (if available)
• Protocol & protocol
summary
• Manufacturing/import
licence
•
• Insurance
• Sample label
• Financial issues
• Informed consent form
18. Time lines:
Clinical Trial directive sets a
17. Form 44
-Particulars of New Drug:
Description of drug & therapeutic
class.
-Data to be submitted
(A) Chem. & Pharmaceutical info.
(B) Animal Pharmacology
(C) Animal Toxicology
(D) Human/Clinical Pharmacology
(Phase I)
(E) Exploratory Clinical Trials
(Phase II)
(F) Bio-availability, dissolution
and stability study Data
(G) Regulatory status in other
countries
(H) Marketing information:
(a) Proposed product
monograph
(b) Drafts of labels and
cartons
(I) Application for test license
18.Timelines
assessment of IND of 30 days timeline for assessment of CTA of
60 days.

19. Pre IND meeting-

Can be requested by sponsor to
obtain guidance on data
necessary for IND submission
 Table 1. Reduced information requirements for IMPs known to the
concerned competent authority
Types of Previous Assessment Quality Data Non-clinical Data Clinical Data

The IMP has a MA in any EU Member

State and is used in the trial:

-Within the conditions of the SmPC SmPC SmPC SmPC

-Outside the conditions of the SmPC SmPC Yes (if appropriate) Yes (if
appropriate)
-With a change to the drug substance S+P+A SmPC 6
manufacture or manufacturer SmPC

-After it has been blinded P+A SmPC

SmPC

Another pharmaceutical form or strength

of the IMP has a MA in any EU Member
State and:
- The IMP is supplied by the MAH P+A Yes Yes

The IMP has no MA in any EU Member

State but drug substance is part of
product with a marketing authorisation in
a MS and:
- is supplied from the same manufacturer P+A Yes Yes
-is supplied from another manufacturer S+P+A Yes Yes

The IMP has a previous CTA in the

Member
State(s) concerned :
-no new data available since CTA No No No
-new data available since CTA New Data New Data New Data

The IMP is a placebo P+A No No

(S: Drug substance data; P : Drug product data; A : appendices of the IMPD;
SmPC: summary of product characteristics)