Global submission of IND (Regulatory affairs).pptx

Global submission of IND - Regulatory affairs
1st sem M. Pharm pharmaceutics

1. AL-AMEEN COLLEGE OF PHARMACY GLOBAL SUBMISSION OF IND (INVESTIGATIONAL NEW DRUG) 1 NITHYAA SHRI S MPHARM 1st YEAR AL-AMEEN COLLEGE OF PHARMACY BENGALURU

2. CONTENTS INTRODUCTION PROCESS TYPES OF IND WHAT SHOULD BE THERE IN IND? FORMAT  SUBMISSION TO U.S. SUBMISSION IN E.U. SUBMISSION IN INDIA 2

3. INTRODUCTION Investigational new drug is defined under 21CFR 312.3(b) as ''new drug or biological drug that is used in clinical investigation. IND is submission to FDA or concerned regulatory body by requesting permission to initiate the study of new drug products. IND is defined as the request from a clinical study sponsor to obtain authorization from FDA to administer an IND or biological product to human. 3

4. PROCESS 4

5. TYPES OF IND'S Commercial IND: Application submitted by companies. Non-commercial IND : 1) Investigator's IND: It is submitted by a physician who initiated and administers and dispenses the drug. 2) Emergency use IND: Human subject in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval for the use. Submission of an IND in accordance with 21CFR sec 312.23 5

6. Treatment IND :Also called expanded access IND . This IND is submitted for experimental drug showing promise. Clinical testing of serious and  life threatening conditions. It is under 21 CFR 312.34. 6

7. WHAT SHOULD BE THERE IN IND? Animal pharmacology and toxicology data Manufacuring information Clinical protocol and investigator information 7 MAIN CONTENTS

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9. FORMAT   1.COVER SHEET(1571): The cover letter is used for triaging and routing of an IND application within FDA and is expected to include the following:  *Submission identifier *Brief explanation of intended clinical use *IND product's name and proposed formulation *IND manufacturer's name and contact information *Reference to an existing IND application 9

10. TABLE OF CONTENTS The table of content for an IND  application is expected to  be detailed to permit the FDA reviewers to locate the items in the application quickly and easily Location of information is provided by volume and page . 10

11. LETTER OF AUTHORIZATION 11

12. CLINICAL PROTOCOL 12

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14. GLOBAL SUBMISSION OF IND 14

15. 15 DRUG APPROVAL IN U.S.

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19.  SUBMISSION OF IND IN EUROPE A clinical trial application (CTA) is filed to the competent authority of the state to conduct the clinical trial within EUROPEAN UNION. The competent authority of that member state evaluates the application and approves to conduct clinical trial. In the EU's countries, the company have a choice of following regulatory Centralized Procedure, Decentralized Procedure, national procedure or mutual recognition procedure. 19

20. CENTRALIZED PROCEDURE 20

21. DECENTRALIZED PROCEDURE 21

22. MUTUAL REGOGNITION 22

23. SUBMISSION OF IND IN INDIA 23

24. From the submission of IND to approval of clinical trial process – 30days. For the whole approval process i.e. approval for marketing of a drug -12 to 18 weeks Emergency IND - FDA and IRB reviews the IND within 5 days or within hours (based on the emergency disease condition). 24

25. The Central Drugs Standard Control Organization (CDSCO), and the office of its leader, the Drugs Controller General (India) [DCGI] were established for review of IND application and conduct of clinical trials. When a company in India wants to manufacture/ import a new drug - licensing authority (DCGI) - Form 44 also submitting the data as given in Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945 25

26. Section 2.4 (a) of Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945 says for those drug substances which are discovered in India all phases of clinical trials are required  Section 2.4 (b) of Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945 says that for those drug substances which are discovered in countries other than India; the applicant should submit the data available from other countries and the licensing authority may require him to repeat all the studies or permit him to proceed from Phase III clinical trials. 26

27. REGULATORY DIFFERENCE 27 DCGI AND CDSCO BSE-  Bovine spongiform encephalopathy (BSE) TSE - transmissible spongiform encephalopathy (TSE).

28. DIFFERENCE ADMINISTRATIVE REQUIREMENTS 28

29. MANUFACTURING AND CONTROL REQUIREMENTS 29

30. REFERENCE https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-applications-clinical-treatment-contents-and-format . https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5188860/ https://www.researchgate.net/publication/367821003_GLOBAL_SUBMISSION_ON_IND https://www.fda.gov/dru gs/investigational-new-drug-ind-application/ind-applications-clinical-investigations-pharmacology-and-toxicology-pt-information. 30