Global submission of abbreviated new drug application (

Pharmaceutical Regulatory Affairs

1. Global Submission of Abbreviated new drug Application (anda) Under the guidance of Dr. K. Sai Sruthi M. Pharmacy, Ph. D. K. Bhanu Sri Chandana 2020MPH40A023 M. PHARMACY Dept. of Pharmaceutics

2. Contents : 2 Introduction Basic Generic Drug Requirements Hatch-Waxman Act Format and Contents of ANDA ANDA Review Process in different countries References

3. 3 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 ANDA is approved, the applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the branded drug. Abbreviated New Drug Application (ANDA ) Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. 

4. 4 Generic applicants must scientifically demonstrate that their product performs in the same manner as the innovator drug.  Demonstration of “bioequivalence” gives the rate of absorption, or bioavailability, of the generic drug, which can then be compared to that of the innovator drug

5. 5 Basic Generic Drug Requirements :

6. 6   Hatch-Waxman Act [ Drug Price Competition and Patent Term Restoration Act] This law encourages the manufacture of  generic drugs  by the  pharmaceutical industry. This amendments established bioequivalence as the basis for approving generic copies of drug products. Under the Hatch-Waxman Amendments, brand-name companies can gain patent term extension for marketing exclusivity.  The Act also gives generic companies  safe harbor  from patent infringement lawsuits during the time when the generic company is preparing its ANDA.

7. 7 Format and Contents of ANDA Application Form Table of Contents Basis for ANDA submission Conditions of use Active Ingredients Routes of Administration Dosage Form and Strength Bioequivalence and Bioavailability Labelling CMC Samples Patent Certifications Disclosure Certifications Other Information

8. 8 ANDA Review Process in US Applicant ANDA Acceptable Review by OGD/CDER Refuse to File Letter Issued Bioequivalence Review Chemistry / Micro Review Request for Plant Inspection Labelling Review No Yes

9. 9 Bioequivalence Review Chemistry / Micro Review, Labelling Review, Request for Plant Inspection Yes Bioequivalence Deficiency Letter Not Approvable Letter Preapproval Inspection ANDA Approval No No Approval deferred pending satisfactory results Yes No

10. 10 ANDA Review Process in INDIA Innovator drug Approved in INDIA Approved Status by CDSCO State Legislature Assembly Manufacturing Licence NOC Issued by SLA CDSCO Zonal / Sub Zonal approval ANDA Approval

11. 11 ANDA Review Process in Europe Innovator drug Approved in Europe EMA Review of application Submission of application to different State assemblies Marketing authorization ANDA Approval

12. 12 www.fda.gov.in https://en.wikipedia.org/wiki/Drug_Price_Competition_and_Patent_Term_Restoration_Act Generic drug regulatory approval process in the USA, Europe, and India G. Sai Bhavani, M. P. Venkatesh*, T. M. Pramod Kumar https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/patent-certifications-and-suitability-petitions https://www.slideshare.net/maruthishanskeli3/global-subbmission-of-ind-nda-anda https://www.slideshare.net/sagarsavale1/abbreviated-new-drug-application-anda References :

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