Drug Registration requirements for Pharmaceuticals in Emerging markets

  • Sri Lakshmi Sowjanya Reddy Singam MISS
  • Koushik Yetukuri
  • Rama Rao Nadendla

Abstract

Registration of pharmaceutical drug products in emerging market is maximum worrying task. Although the requirements are harmonized in regulated international locations by way of CTD (Common technical document) submitting, yet others have considerable diversity in necessities. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe collectively for various factors of drug registration. But there is no such harmonized guideline for rising marketplace besides Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exists in clusters with their mutual situation. Quality, Safety and Efficacy information has significance importance in dossier registration. Pharmaceutical Industries has to conform with regulatory requirement in Emerging market and for betterment of public Health and protection. The business importance of markets is increasing globally. It is important for pharmaceutical enterprise to address the regulatory necessities for betterment of public and to ensure their place in the marketplace. The review additionally explains a short approximately extraordinary regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier software in Emerging marketplace.

Keywords: Dossier Registration, Emerging Markets, GCC, ASEAN, Common technical document (CTD), WHO, Harmonization, Drug Product

Downloads

Download data is not yet available.

References

1. Anne Sraders. The Street [Internet]. thestreet.com; 2018 Dec 31 [cited 2020 May 13]: [updated 2020 Feb 11]. Available from:
https://www.thestreet.com/markets/emerging-markets/what-are-emerging-markets-14819803
2. Saudi Arabia inclusion emerging markets [image on the internet]. msci.com; 2019 Mar 28 [cited 2020 Nov 18]. Available from:
https://www.msci.com/www/blog-posts/saudi-arabia-inclusion-and/01297979912
3. Badjatya JK, Bodla R. Drug Product Registration in Semi-Regulated Market. Int J Drug Reg Affairs [Internet]. 2018 Feb.6 [cited 2020 Nov.17];1(2):1-. Available from:
http://ijdra.com/index.php/journal/article/view/3
4. Will Kenton. Investopedia [Internet]. Investopedia.com; [cited on 2020 Jun 06]: [updated 2019 Aug 28]. Available from:
https://www.investopedia.com/terms/r/regulated-market.asp
5. Badjatya JK. Overview of Registration Requirements for Pharmaceuticals in Emerging Market. Journal of Drug Delivery and Therapeutics [Internet]. 2013 [cited 2020 Jun10]; 3(2):227-232. Available from:
http://jddtonline.info/index.php/jddt/article/view/466\
6. Nancy Mann J. Invest [Internet]. acorns.com; [cited on 2020 Jun 24]: [updated 2019 Dec 31]. Available from:
https://www.acorns.com/money-basics/what-s-the-difference-between-emerging-and-developed-markets-/
7. Kashyap P, Duggal E, Budhwaar V, Nanda DA, Badjatya JK. DRUG APPROVAL PROCESS: A CONTRASTIVE APPROACH. Int J Drug Reg Affairs [Internet]. 2018Feb.11 [cited 2020 Nov.17];1(2):11-9. Available from:
http://ijdra.com/index.php/journal/article/view/107
8. Patel P, Badjatya JK, Hinge M. Comparative study of Regulatory requirements of Drug Product in Emerging market. Int J Drug Reg Affairs [Internet]. 2019 Sep.15 [cited 2020 Dec. 12];7(3):48-2. Available from:
http://ijdra.com/index.php/journal/article/view/350
9. ICH M4S Guideline- ICH Guidelines [Internet]. ICH; 2002 Dec [cited 2020 Jul 16]. Available from:
https://database.ich.org/sites/default/files/M4S_R2_Guideline.pdf
10. CDER Office of Compliance Office of Drug Security (IECB) US Food and Drug Administration [Internet]. US: FDA; 2020 [cited 2020 Aug 06] Available from:
https://www.fda.gov/media/91749/download
11. James Strachan. The Medicine Maker [Internet]. themedicinemaker.com; 2017 [cited 2020 Aug 12]. Available from:
https://themedicinemaker.com/business-regulation/harmonization-regulation-goes-global
12. Tripathy S, Murthy PN, Patra BP. Integrating PLCM strategy in Pharmaceutical Emerging Market. Int J Drug Reg Affairs [Internet]. 2018 Dec.20 [cited 2020Nov.17];6(4):21-2. Available from:
http://ijdra.com/index.php/journal/article/view/280
13. WHO guidelines for stability testing of active substances and pharmaceutical products [Internet]. WHO [cited 2020 Sep]: [updated 2019 Jan 01]. Available from:
http://apps.who.int/medicinedocs/documents/s19133en/s19133en.pdf
14. Nagaraju P et. al. Comparison of Generic Drug Registration Requirements in ASEAN Countries [Internet]. 2015 [cited 2020Aug 14]; 5(1): 145-149
Available from:
https://www.ijrpc.com/files/13-01-15/15-520.pdf
15. Antoine Serge A, J.C. Y, Pola E Y, Jean-Yves P. Comparative study of the harmonization of pharmaceutical regulations in the western and central sub-regions of Africa. Int J Drug Reg Affairs [Internet]. 2018Dec.20 [cited 2020Nov.17];6(4):46-1. Available from:
http://ijdra.com/index.php/journal/article/view/288
16. Ndomondo-Sigonda M et. al. The African Medicines Regulatory Harmonization Initiative: Progress to Date [Internet]. Pubmed; 2011 Feb [cited 2020 Jul 04]; 6(2). Available from:
https://pubmed.ncbi.nlm.nih.gov/21252936/
17. Sravani M et. al. Regulatory Aspects of Pharmaceuticals in Gulf Cooperation Council Countries [Internet]. ijpacr.com; 2017 Jul- Sep [cited 2020 Jun 10]; 3(3):397-414. Available from:
http://www.ijpacr.com/files/21-07-2017/01.pdf
18. Tomas L. Regional Harmonization of Telecommunications Regulatory Frameworks outside the European Union: A Case of the Gulf Cooperation Council States [Internet]. imaginar.org;2008 [cited 2020 Sep 15]: [updated 2019]. Available from:
http://www.imaginar.org/taller/its2008/106.pdf
19. The GCC Guidelines for Bioequivalence. Executive Board of the Health Ministers’ Council for GCC State [Internet]. old.sfda.gov;2011 Feb 3 [cited 2020 Sep 25]. Available from:
https://old.sfda.gov.sa/en/drug/drug_reg/Regulations/The-GCC-Human-Drugs%20Submission-v2.1.pdf
20. Badjatya JK & Bodla R. Harmonization & Advancement in Pharmaceutical Industry [internet]. ijdra.com; 2019 Feb [cited Nov 08]; 1(2):7-10. Available from:
http://ijdra.com/index.php/journal/article/view/4
Statistics
45 Views | 0 Downloads
How to Cite
Singam, S. L. S. R., K. Yetukuri, and R. R. Nadendla. “Drug Registration Requirements for Pharmaceuticals in Emerging Markets”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 4, Dec. 2020, pp. 73-82, doi:10.22270/ijdra.v8i4.442.