DOCUMENTATION IN ANDA & NDA REGULATORY APPROVAL PROCESS.pptx

This comprehensive guide provides a detailed exploration of the ANDA (Abbreviated New Drug Application) and NDA (New Drug Application) approval processes. It offers a clear understanding of the requirements, timelines, and regulatory guidelines involved in obtaining FDA approval for both generic and innovative drugs.

1. 1 ANDA REGULATORY APPROVAL PROCESS AND NDA APPROVAL PROCESS PRESENTED BY : Mr. KARANAM MITHUN Mr. SAGAR MATHAD DEPARTMENT OF PHARMACEUTICS KLE COLLEGE OF PHARMACY HUBLI

2. Contents Abbreviated New Drug Application (ANDA): Introduction. Requirement for filing an ANDA ANDA Process ANDA Application form New Drug Application (NDA): Introduction. Drug development process NDA forms Format of application. Review process. Action letter. NDA process NDA application form. References 2

3. 3 ABBREVIATED NEW DRUG APPLICATION (ANDA)

4. INTRODUCTION An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references. All approved products, both innovator and generic, are listed in FDA’s Approved Drug Products with Therapeutic Equivalence & Evaluations (Orange Book). 4

5. Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical and clinical data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product performs in the same manner as the innovator drug. For the generic drug to be therapeutically equivalent, two clinical characteristics must apply: Pharmaceutical equivalence Bioequivalence. 5

6. I. Pharmaceutical equivalence means that the active ingredient(s), dose form, route of administration, and strength are the same for both the branded product and the generic product. II. Bioequivalence is when both products have comparable bioavailability when studied under similar conditions. To be approved by FDA, the generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug. The "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Hatch-Waxman Amendments , established bioequivalence as the basis for approving generic copies of drug products. 6

7. REQUIREMENT FOR FILING AN ANDA At the time of filing an ANDA application, the applicant seeking approval of particular drug (innovator drug or patent expired drug ) that make one of four certification about legal status of patent status they are: 7

8. 8 PARA I PARA II Required patent information has not been filed FDA may approve generics immediately, one or more applicants may enter. FDA may approve generics immediately, one or more applicants may enter. Patent has expired

9. 9 PARA III PARA IV Patent not expired, will be expired on a specific date. Patent is invalid or non infringed by generic applicant. FDA may approves, ANDA effective on the date of expiration, one or more applicant may enter. Generic applicant file notice to patent holder.

10. 10 Applicant 10 ANDA 10 10 Refuse to file letter issued Bioequivalence review Chemistry/micro review Request for plant inspection Labelling review Bioequivalence deficiency letter Not approvable letter Approval deferred pending satisfactory result ANDA approved Acceptable& Complete? Bioequivalence review acceptable? Chemistry/ micro/labelling review acceptable? Preapproval inspection acceptable No Yes Review by CDER No No No Yes Yes ANDA PROCESS

11. NEW DRUG APPLICATION (NDA) 11

12. INTRODUCTION NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing. The data gathered during the animal studies and human clinical trials of an Investigational new product become part of the NDA. 12

13. DRUG DEVELOPMENT PROCESS 13 Animal testing of a drug Short term Pre Clinical Studies Phase - I Safety 20-100 Individuals 1-2 Years Phase -II Efficacy & Safety 100-300 Individuals 1-2 Years Phase - III Confirm Safety & efficacy 1000-3000 Individuals 2-3 Years Clinical Studies Long Term Phase-IV Post Marketing Surveillance FDA Approval Drug discovery & Development IND Application Filing NDA Filing

14. NDA FORMS Form FDA - 356h : Application to market a new drug, Biologic or an antibiotic drug for human use. It includes: Applicant information. Product/Manufacturing information. Pre-clinical studies Labelling. Form FDA – 3397 : User fee cover sheet. FDA has the authority to collect user fees for certain drugs and biologics license application. Pharmaceutical companies pay for the review of certain new drugs, biologics or supplements. Form FDA – 3331 : NDA Field Alert Report (FAR). FAR (Field Alert Report) is submitted to the FDA when the drug is already distributed in the market and the manufacturer become aware of any information that can affect the identity, quality, strength or potency of the drug. This reporting mechanism is crucial for the FDA to take appropriate actions in addressing potential safety concerns, issuing drug recalls if necessary, and ensuring patient safety. 14

15. FORMAT OF APPLICATION 3 copies of the application are required: Archival copy Review copy Field copy 15

16. 1. Archival copy: The cover letter. The administrative section. It must contain four copies of labelling section. It must contain additional three copies of CMC and methods validation package in a separate binder. 16

17. 2. Review copy: It contains NDA's technical sections along with the cover letter form FDA-356h, NDA index as well as individual table of content, labelling sections, and application summary. 3. Field copy: It is required by FDA inspectors during pre-approval facilities inspections. In addition to content of review copy, this includes CMC (Chemistry, Manufacturing and Controls) and methods validation package. 17

18. REVIEW PROCESS Under Food & Drug Administration modernization act, depending on the anticipated therapeutic or diagnostic value of submitted NDA, its review might receive 1. Priority or 2. Standard classification. 18

19. Priority review: The drug product if approved would be a significant improvement compared with marketed products in treatment, diagnosis or prevention of a disease. Standard review: All non priority applications will be considered standard application. i.e., application for drugs similar to those on the market are considered standard. 19

20. ACTION LETTER An approval letter: It signifies that all substantive requirements for approval are met with and that the sponsor company can began marketing the drug as of the date on letter. Approvable letter: Minor deficiencies that must be addressed before an approval letter is sent. Within 10 days of receipt sponsor must respond. Non approvable letter : It signifies that FDA has a major concern with the application and will not approve the proposed drug product for marketing as submitted. 20

21. 21 Applicant NDA application to FDA Forwarded to CDER Check filing eligibility Applicable for filing Inform the applicant Forward to reviewer Submit report to CDER Marketing Approval Inform about deficiency to the applicant Amend document to resolve issues No Yes Fail Pass NDA Process

22. REFERENCES Generic Drug Solid Oral Dosage Forms Product Development Second Edition Edited by Leon Shargel Applied Biopharmaceutics Raleigh, North Carolina, USA Isadore Kanfer Rhodes University Grahamstown, South Africa. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons.Inc. https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda https://www.excedr.com/blog/what-is-abbreviated-new-drug-application 22

23. THANK YOU 23