Volume : 08, Issue : 08, August – 2021
Title:
22.COMPARATIVE STUDIES FOR FILING AND MARKETING AUTHORISATION OF GENERIC DRUGS IN EUROPE, UNITED STATES AND INDIA
Authors :
M Tejorani*, Brahmaiah Bonthagarala, G.Ramakrishna, M.V.Nagabhushanam
Abstract :
The goal of this study is to understand differences in regulatory requirements, bio-equivalence data, drug registration, approval process and, guidelines associated with the generic drug filing in the USA, Europe, and India and also provide enough information for the drug safety and efficacy in humans. Generic drugs are identical, indistinguishable within an acceptable bio-equivalent level for the innovator product name counterpart esteems to the “Pharmacokinetics and Pharmacodynamics” properties. A generic drug product must meet the standards, established by “United States Food and Drug Administration 9USFDA)” in USA, “Central drugs standards control organization (CDSCO)” in India, and “European Medical Agency (EMA)” in Europe to be approved to successfully enter the pharmaceutical market. It must their bioequivalent to the branded medicine. In USA and India, in Module II there is complete information on the quality overall summary. Hence by comparing all the above differences and similarities, generic drug approval procedures and submissions become easy for registration of drugs in those countries. This compilation provides a view of harmonizing the Generic Drug submissions in these three countries which may reduce the tedious work that has to be done in altering the submission format.
Keywords: CTD, generic drugs, bioequivalence, Bio-equivalence, CTD, Generic Drug Submissions, USFDA, DCGI, EMA
Cite This Article:
Please cite this article in press M Tejorani Jilani et al, Comparative Studies For Filing And Marketing Authorisation Of Generic Drugs In Europe, United States And India., Indo Am. J. P. Sci, 2021; 08(8).
Number of Downloads : 10
References:
1. International Conference and Expo on Generic Drug Market and Contract Manufacturing Nov 07- 09, 2016 Barcelona, Spain https://www.omicsonline.org/conferences-list/generic-pills-and-generic-medication
2. History of ICH , https://www.ich.org/about/history.html
3. ICH Guideline: The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality – M4Q; Quality Overall Summary of Module 2, Module 3: Quality,: https://www.ich.org
4. Apeksha Gupta , REGISTRATION DOSSIER OF PHARMACEUTICALS https://www.pharmatutor.org/articles/registration-dossier-pharmaceuticals
5. European medicines agency Generic medicine https://www.ema.europa.eu/en/glossary/generic-medicine
6. 6.G.SaiHanuja, B.SaiKumari, M.V.Nagabhushanam, D.Nagarjuna Reddy, BrahmaiahBonthagarala, Regulatory Requirements for Registration of Generic Drugs in “BRICS” Countries, International Journal of Pharmaceutical Science and Health Care, ISSN 2249 – 5738, Issue 6, Vol. 6 , November-December 2016, 20-40.
7. L Evangeline, NVN Mounica, V Sharmila Reddy, MV Ngabhushanam, D Nagarjuna Reddy and Brahmaiah Bonthagarala ,Regulatory process and ethics for clinical trials in India (CDSCO)- A Review, The Pharma Innovation Journal, ISSN (E): 2277- 7695 , ISSN (P): 2349-8242,2017; 6(4): 165-169.
8. B.Sai Kumari, G.SaiHanuja, M.V.Nagabhushanam, D.Nagarjuna Reddy, Brahmaiah Bonthagarala, Current Regulatory Requirements for Registration of Medicines, Compilation and Submission of Dossier in Australian Therapeutic goods Administration, International Journal of Advanced Scientific and Technical Research ,ISSN 2249-9954, Issue 6 volume 6, November-December 2016, 144-157.
9. Shaik Salman Basha, S. M. Shakeel, M. V. Nagabhushanam, D. Nagarjuna Reddy, BrahmaiahBonthagarala, The Assesment of Current Regulatory Guidelines for Biosimilars- A Global Scenario, World Journal of Pharmaceutical Research, ISSN 2277– 7105, volume 6, Issue 1, 351-369.
10. S.M.Shakeel, Shaik Salman Basha, M.V.Nagabhushanam, D.Nagarjuna Reddy, BrahmaiahBonthagarala, Comparision of Regulataory Requirements for Generic Drugs Dossier Submission in United States and Canada, International Journal of Pharmaceutical Science and Health Care, ISSN 2249 – 5738, Issue 6, Vol. 6 , November-December 2016, 1-19.
11. Harmonised Technical Guidance for eCTD Submissions in the EU http://esubmission.ema.europa.eu
12. Rahul Raj .S, N. Vishal Gupta* Comparative Study of Generic Drug Approvalprocess in EU, USA and China, Int. J. Pharm. Sci. Rev. Res., 42(2), January – February 2017; Article No. 14, Pages: 67-73
13. Comparison on regulatory requirement between US and EU, http://pharmatreasures.blogspot.in/2012/06/generic-drugs-filing-requirements-us-vs.html
14. Generic drug, wikipedia.org/wiki/Generic drug.
15. Guidance for Industry: Preparation of a Drug Submission in Common Technical Document (CTD) Format