Scribd
Upload
286 views

Ind Differences

The document compares the regulatory requirements for Investigational New Drug (IND) applications in the US, EU and India. Some key similarities and differences include: - The US has one regulatory authority (FDA), while the EU has a central authority (EMEA) and multiple competent authorities. India also has one authority (DCGI). - All three regions require approvals from ethics committees and regulatory authorities. The EU also requires a research ethics committee opinion. - Consent forms differ between regions - the US has one-part consents while the EU uses two-part consents. - Application forms also vary, with the US using Form 1571, the EU using CTA Ann

Uploaded by

api-3810976
Copyright
© Attribution Non-Commercial (BY-NC)
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
286 views

Ind Differences

The document compares the regulatory requirements for Investigational New Drug (IND) applications in the US, EU and India. Some key similarities and differences include: - The US has one regulatory authority (FDA), while the EU has a central authority (EMEA) and multiple competent authorities. India also has one authority (DCGI). - All three regions require approvals from ethics committees and regulatory authorities. The EU also requires a research ethics committee opinion. - Consent forms differ between regions - the US has one-part consents while the EU uses two-part consents. - Application forms also vary, with the US using Form 1571, the EU using CTA Ann

Uploaded by

api-3810976
Copyright
© Attribution Non-Commercial (BY-NC)
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
You are on page 1/ 6

IND

COMPARISON OF REGULATORY REQUIREMENT FOR IND APPLICATION:

US EU INDIA

1. One Regulatory authority – 1. Central Regulatory authority - 1. One Regulatory Authority - DCGI
FDA- CDER/CBER EMEA (Europe Medical Agency) &
Many CAs (Competent
Authorities)
[UK- MHRA: Medicines and
Healthcare products Regulatory
agency]

2. Investigational New Drug 2. Clinical trial authorization 2. Application for permission to


(IND) Application (CTA) Application import/manufacture New Drug or to
undertake Clinical Trial -Form 44

3. Follow Code of Federal 3.Follow EU Clinical Trials 3. Follow Schedule Y under Drugs
Regulations (CFR)- Directive – & Cosmetics Act, 1940 (DCA)
21 CFR 312.20-38 EU Directive 2001/20/EC
which came in to force on 1/05/04

4. Approvals required 4.Approvals required 4. Approvals required


-Ethics Committee -R&D Committee -Ethics Committee
-FDA -DCGI
-Research Ethics Committee
-Regulatory Authority/Competent
Authority

5. ------ 5. EUDRACT database –Apply for 5. ------


EUDRACT number is must.

6. US “Resident US Agent” 6.Sponsor EU Legal 6. ---------


required by non-US sponsors in Representative
US

7.Insurance of subjects is not 7.Insurance of subjects is 7.Insurance not mandatory


mandatory for the trial. 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: 17. Clinical Trial Authorization 17. Form 44
application: -Particulars of New Drug:
A. Cover sheet (Form FDA–1571) -Cover letter, confirmation of Description of drug & therapeutic
EudraCT number & authorization class.
B. A table of contents. for applicant to act for Sponsor -Data to be submitted
(A) Chem. & Pharmaceutical info.
C. Introductory statement -Application form (Annex 1) & fee (B) Animal Pharmacology
A.Trial identification (EudraCT (C) Animal Toxicology
D. General Investigational plan number) (D) Human/Clinical Pharmacology
18. Sponsor id. (Phase I)
E. Investigator’s brochure. 18. Applicant id. (E) Exploratory Clinical Trials
18. Info.on the IMPs –IMPD (Phase II)
F. Protocols 18. Info. On the Placebos (F) Bio-availability, dissolution
-Study protocol 18. Sites responsible for IMP and stability study Data
-Investigator data release (G) Regulatory status in other
-Facilities data G. General Info. On the trial countries
-IRB data 18. Pop. Of trial subjects (H) Marketing information:
18. Proposed sites in the (a) Proposed product
G. Chemistry, manufacturing, and Member monograph
control information- State (b) Drafts of labels and
Composition, stability, controls 18. Ethics Committee/MS cartons
Competent Authority (I) Application for test license
H. Pharmacology and toxicology K. Check list
information-
Pre clinical data
-IMP Dossier (IMPD)
18. Previous human
experience with the -Accompanying documents
investigational drug. • Investigator Brochure
• EC opinion (if available)
J. Additional information. • Protocol & protocol
summary

• Manufacturing/import
licence

•
• Insurance
• Sample label
• Financial issues
• Informed consent form

18.Timelines: 18. Time lines: 18.Timelines


FDA sets a timeline for Clinical Trial directive sets a
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)

You might also like