A comprehensive review on registration requirements for Drug Approval in India, South Africa and US
Abstract
The drug approval process is country-specific. The regulatory framework of all the national regulatory agencies differ from one another in terms of administration and product specific guidelines for registration of drug and drug products in a particular country. Every national regulatory authority provides regulatory guidelines for drug or drug product registration and the pharmaceutical industries which rely upon these guidelines prepare drug applications along with all the required administrative, non-clinical and clinical data in the form of a technical dossier which is known as Common Technical Document. This Dossier is prepared either in an electronic format or in the paper submission format. This review focuses on the comparative study of the registration requirements for getting a drug approval in India, South Africa and United States of America. The significant differences between the technical requirements of these three markets have been discussed in detail.
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References
https://cdsco.gov.in/opencms/opencms/en/Home/#
2. SAHPRA. About Us [Internet]. South Africa: SAHPRA; 2021 [cited 2021 Mar 03]. Available from:
https://www.sahpra.org.za/who-we-are/
3. Keyter A, Gouws J, Salek Sand Walker S. The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System [Internet]. 2018 [cited 2021 Mar 03]; 20(1): 1-10. Available from:
https://journals.sagepub.com/doi/full/10.1177/2168479018776649
4. USFDA. What We Do [Internet]. US FDA; 2018 Mar 28 [cited 2021 Mar 06]. Available from:
https://www.fda.gov/about-fda/what-we-do
5. ICH. M4: The Common Technical Document [Internet]. ICH; 2021 [cited 2021 Mar 08]. Available from:
https://www.ich.org/page/ctd
6. Sama R, Swarna Latha K, Sathish M, Gowthami Krishna M and Santhosh P. Electronic Common Technical Document (eCTD): A Review of History, Benefits of implementing, challenges, modules, risks involved in eCTD publishing and Quality Control [Internet]. 2016 [cited 2021 Mar 04]; 6(2): 133-149. Available from:
http://ijpcbs.com/files/12-04-2016/04-620.pdf
7. ICH. ICH M2 EWG – Electronic Common Technical Document Specification [Internet]. ICH; 2008 Jul 16 [cited 2021 Mar 05]. Available from:
https://admin.ich.org/sites/default/files/inline-files/eCTD_Specification_v3_2_2_0.pdf
8. eCTD 247. Benefits of Electronic CTD Submissions [Internet]. ectd247; 2021 [cited 2020 Dec 12]. Available from:
https://ectd247.com/benefits/
9. N. Vishal Gupta, C. Mohan Reddy, K. Pradeep Reddy, R. Ajay Kulkarni, H.G. Shivakumar. Process of Approval of New Drug in India with Emphasis on Clinical Trials. International Journal of Pharmaceutical Sciences Review and Research [Internet]. 2012 [cited 2021 Mar 05]; 13(2): 17-23. Available from:
https://www.globalresearchonline.net/journalcontents/v13-2/004.pdf
10. S.D.Mankar, V.D. Gholap, T.P. Zende, R.S.Dighe. Drug Regulatory Agencies in India, USA, Europe and Japan - A Review. International Journal of Institutional Pharmacy and Life Sciences [Internet]. 2014 [cited 2021 Mar 05]; 4(2): 288-297. Available from:
http://www.ijipls.com/archives.php?archid=18
11. Sawant AM, Mali DP and Bhagwat DA. Regulatory Requirements and Drug Approval Process in India, Europe and US. Pharmaceutical Regulatory Affairs [Internet]. 2018 [cited 2021 Mar 05]: 7(2): 1-10. Available from:
https://www.hilarispublisher.com/open-access/regulatory-requirements-and-drug-approval-process-in-india-europe-and-us-2167-7689-1000210.pdf
12. CDSCO. Guidance for Industry on Preparation of Common Technical Document for Import/Manufacture and Marketing Approval of New Drugs for Human Use (New Drug Application - NDA) - Draft Guidance Document [Internet]. CDSCO FDA Bhavan Kotla Road, New Delhi; 2010 Oct 28 [cited 2021 Mar 06]. Available from:
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadGazette_NotificationsFiles/CTD%20Guidance%20Final.pdf
13. Krishnasis Chakraborty, Kavita Yadav. Drug approval process in US, Europe and India and its regulatory requirements: A Review. International Journal of Drug Regulatory Affairs [Internet]. 2018 [cited 2021 Mar 05]: 6(3): 31-39. Available from:
http://ijdra.com/index.php/journal/article/view/332
14. Jawahar.N, Vidhya Lakshmi. T. Regulatory Requirements for the Drug Approval Process in US, Europe and India. Journal of Pharmaceutical Sciences and Research [Internet]. 2017 [cited 2021 Mar 06]: 9(10): 1943-1952. Available from:
https://www.jpsr.pharmainfo.in/Documents/Volumes/vol9Issue10/jpsr09101759.pdf
15. Pharmexcil – Pharmaceuticals Export Promotion Council of India. Regulatory & Market Profile of South Africa [Internet]. Ministry of Commerce & Industry, Government of India [Internet]. Pharmexcil; 2017 [cited 2021 Mar 06]. Available from:
https://pharmexcil.com/uploadfile/ufiles/South_Africa_Regulatory_Market_Profile.pdf
16. SAHPRA. Guidance for the submission of the South African CTD /eCTD - General & Module 1 [Internet]. South Africa: SAHPRA; 2019 May. [cited 2021 Mar 05]. Available from:
https://www.sahpra.org.za/wp-content/uploads/2020/02/ 2.01-Guidance_General_Module_1_May19_v6-1.pdf
17. USFDA. New Drug Application (NDA) [Internet]. US:US FDA; 2019 Jun 10 [cited 2021 Mar 06]. Available from:
https://www.fda.gov/drugs/types-applications/new-drug-application-nda
18. ICH. M4Q: The CTD – Quality – Guidance for Industry [Internet]. US: US FDA; 2001 Aug [cited 2021 Mar 05]. Available from:
https://www.fda.gov/media/71581/download
19. USFDA. Providing Regulatory Submissions in Electronic Format-NDAs – Guidance for Industry. US: US FDA; 1999 Jan [cited 2021 Mar 06]. Available from:
https://www.fda.gov/media/76482/download
20. ClinRegs. India v/s South Africa [Internet]. National Institute of Allergy and Infectious Diseases; 2020 Jul 23 [cited 2021 Mar 06]. Available from:
https://clinregs.niaid.nih.gov/country/india/south-africa#_top
21. Ananth L, Gurbani NK, Kumar S, Gujavarti B. A retrospective study of Warning Letters issued by US FDA over 2015-2017. Int J Drug Reg Affairs [Internet]. 2018Jun.15 [cited 2021Mar.06];6(2):48-3. Available from:
http://ijdra.com/index.php/journal/article/view/242
22. Budhwar V, Singh AK, Choudhary M. REGULATIONS OF ORPHAN DRUGS IN USA, EU AND INDIA-A COMPARATIVE STUDY. Int J Drug Reg Affairs [Internet]. 2018Feb.13 [cited 2021Mar.05];4(3):30-7. Available from:
http://ijdra.com/index.php/journal/article/view/187
23. Gupta S, Popli H. Regulation of Blood and Blood products in India, USA and EU. Int J Drug Reg Affairs [Internet]. 2018Jun.15 [cited 2021Mar. 06];6(2):72-4. Available from:
http://ijdra.com/index.php/journal/article/view/246
24. Budhwar V, Yadav S, Choudhary M, Nitesh,. A Comprehension Study on Regulation of Herbal Drugs in USA, European Union and India. Int J Drug Reg Affairs [Internet]. 2017Dec.7 [cited 2021Mar. 06];5(4):8-17. Available from:
http://ijdra.com/index.php/journal/article/view/205
25. Rani A, Shukla VK. Impact of rules for New Drug and Clinical Trial in India. Int J Drug Reg Affairs [Internet]. 2020Mar.16 [cited 2021Mar. 03];8(1):25-0. Available from:
http://ijdra.com/index.php/journal/article/view/379
26. Rampal A, Kanti SPY. Cosmetics in US and India: Overview of Regulations and Registration process. Int J Drug Reg Affairs [Internet]. 2020Dec.15 [cited 2021Mar. 04];8(4):20-4. Available from:
http://ijdra.com/index.php/journal/article/view/430
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