Comparative study of Regulatory requirements of Drug Product in Emerging market

  • Preeti Patel
  • Jitendra Kumar Badjatya
  • Madhuri Hinge

Abstract

Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. 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 together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exist in clusters with their mutual concern. The optimization and harmonization requirements has become mandatory and can be examined by the incidence of higher cost involved in availability of drugs, quality requirement of premise and research and development, regional registration requirements. Quality, Safety and Efficacy data has significance importance in dossier registration. Pharmaceutical Industries has to comply with regulatory requirement in Emerging market and for betterment of public Health and safety.
The review also explains a brief about different regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier application in Emerging market.

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

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References

1. Badjatya JK, Bodla R. Drug product registration in semi-regulated market. International Journal of Drug Regulatory Affairs [Internet]. 2018 Feb 06 [cited 2019 Aug 06]; 1(2):1-6. Available from:
https://ijdra.com/index.php/journal/article/view/3
2. Tripathy S, Murthy PN, Patra BP. Integrating PLCM strategy in Pharmaceutical Emerging Market. International Journal of Drug Regulatory Affairs [Internet]. 2018 Dec 15 [cited 2019 Jul 15]; 6(4):21-32. Available from:
http://ijdra.com/index.php/journal/article/view/280
3. Badjatya J, Bodla R. Overview of Registration Requirements for Pharmaceuticals in Emerging Market. Journal of drug delivery and therapeutics [Internet]. 2013 Mar 02 [cited 2019 Jul 24]; 3(2): 227-232. Available from: http://jddtonline.info
4. Alistair Davidson, Senior Director, Regulatory Delivery Solutions, Regulatory Strategy for the Emerging Markets –Far East, Africa, Middle East, Latin America [Internet]. ppdi; 2019 [cited 2019 Jul 21]. Available from:
www.ppdi.com
5. ICH. The Common Technical Document [Internet]. ICH; 2019 [cited 2019 Jul 26]. Available from:
https://www.ich.org/products/ctd.html
6. ICH M4S Guideline: Nonclinical Overview and Nonclinical Summaries of Module 2 and Module 4: Safety (R2) [Internet]. ICH; 2002 Dec [cited 2019 Jul 22]. Available from:
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R2_Safety/M4S_R2_.pdf
7. ICH. The eCommon Technical Document [Internet]. ICH; 2019 [cited 2019 Jul 12]. Available from:
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M8/M8_eCTD_Concept_Paper.pdf
8. ICH .Q3B Guideline Impurities in New Drug Products Q3 (R2) [Internet]. ICH; 2006 Jun [cited 2019 Jul 22]. Available from:
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3B_R2/Step4/Q3B_R2__Guideline.pdf
9. ICH .Q3A Guideline Impurities in New Drug Products Q3A (R2) [Internet]. ICH; 2006 Jun [cited 2019 Jul 24]. Available from:
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3A_R2/Step4/Q3A_R2__Guideline.pdf
10. ICH. Q2 (R1) Validation of Analytical Procedure Q2 (R1) [Internet]. ICH; 2005 Nov [cited 2019 Jun 08]. Available from:
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf
11. EMA. Guideline on excipients in dossier for application of marketing authorization of medical products [Internet]. EMA; 2007 Jun [cited 2019 Jun 12]. Available from:
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-excipients-dossier-application-marketing-authorisation-medicinal-product-revision-2_en.pdf
12. ICH. Q6A. Specifications test procedure and acceptance criteria for new drug substance and new drug products (chemical substances) [Internet]. ICH; 1996 Oct [cited 2019 May 27]. Available from:
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6A/Step4/Q6Astep4.pdf
13. ICH .Q1A (R2). Guideline Stability testing in New Drug Substance and New Drug Products Q1A (R2) [Internet]. ICH; 2006 Jun [cited 2019 Jul 21]. Available from:
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2_Guideline.pdf
14. ICH. E9. Guideline on statistical principal of clinical trial E9 [Internet]. ICH; 2006 Jun [cited 2019 Jul 16]. Available from:
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf
15. ICH. S3A Guideline on toxicokinetics S3 (A) [Internet]. ICH; 2006 June [cited 2019 July 26]. Available from https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S3A/Step4/S3A_Guideline.pdf
16. Patel D, Badjatya JK, Patel A. Preparation and Review of Chemistry, Manufacturing and Control (CMC) Sections of CTD Dossier for Marketing Authorization. International Journal of Drug Regulatory Affairs [Internet]. 2017 Jun 08 [cited 2019 Aug 01]; 5(2):1-12. Available from:
https://ijdra.com/index.php/journal/article/view/196
17. Serge AA, Yavo JC, Yessibi Pola E, Jean-Yves P. Comparative study of the harmonization of pharmaceutical regulations in the western and central sub--regions of Africa. International Journal of Drug Regulatory Affairs [Internet]. 2018 Dec 15 [cited 2018 Dec 15]; 6(4):46-51. Available from:
https://ijdra.com/index.php/journal/article/view/288
18. World Health Organization [Internet]. WHO; 2018 [cited 2019 Aug 11]. Available from: http://www.who.int/
19. Ghangas J, Jain N, Sinha A. A critical view of harmonization of regulatory requirements for Generic Drug approval submissions in ASEAN countries. International Journal of Drug Regulatory Affairs [Internet]. 2019 Mar 16 [cited 2019 Aug 10]; 7(1):13-24. Available from:
https://ijdra.com/index.php/journal/article/view/297
20. M. Sravani, B. Gowthami, E. Prabhahar and N. Rama Rao; Regulatory Aspects Of Pharmaceuticals In Gulf Co-operation Council Countries; International Journal of Pharma and Chemical Research I [Internet] 2017 Jul-Sep [cited 2019 Jun 14]; 3(3): 397-414.Available from:
http://www.ijpacr.com/files/21-07-2017/01.pdf
21. Badjatya JK, Bodla R. Harmonization & Advancement in Pharmaceutical Industry. International Journal of Drug Regulatory Affairs [Internet]. 2018 Feb 06 [cited 2019 Aug 16]; 1(2):7-10. Available from:
https://ijdra.com/index.php/journal/article/view/4
22. The Guideline for bioequivalence [Internet]. GCC; 2006 June [cited 2019 Jul 16]. Available from:
file:///C:/Users/admin/Desktop/minor%20work/guidline/GCC_Guidelines_Bioequivalence.pdf
23. The Asean guideline.org [Internet]. ASEAN; 2018. [cited 2019 Jul 12]; Available from:
http://www.asean.org/storage/ images/archive/20605.pdf.
24. ASEAN ICH.org [Internet]. hsa; 2018 [cited 2019 Jul 25]; Available from:
https://www.hsa.gov.sg/content/dam/HSA/HPRG/Western_Medicine/Overview_Framework_Policies/Guidelines_on_Drug_Registration/Industry%20Updates/Annex%20B.%20ASEAN%20Guideline%20for%20the%20Conduct%20of%20BE%20Studies.pdf
25. Vaishnav, M., C. Kothari, and M. Shah. Regulatory Technicalities for Drug Produce registration In Brazil. International Journal of Drug Regulatory Affairs [Internet]. 2017 Dec [cited 2019 Jul 25]; 5(4): 18-25. Available from:
https://www.researchgate.net/publication/279630366_An_Update_of_the_Brazilian_Regulatory_Bioequivalence_Recommendations_for_Approval_of_Generic_Topical_Dermatological_Drug_Productsbjiiioo
26. Randeria J, Dedania R, Dedania Z, Jain V, Danej M. Regulatory requirements for Dossier submission in African Countries (Kenya, Uganda, and Tanzania) - A Review. International Journal of Drug Regulatory Affairs [Internet]. 2018 Jun 15 [cited 2019 Jun 30]; 6(2):14-1. Available from:
https://ijdra.com/index.php/journal/article/view/231.
27. Rediguieri, C.F., Cristofoletti, R. Soares; Similarities and differences of international guideline for bioequivalence an updates of the brazillian requirements. The AAPS journal [Internet]. 2014 [cited 2019 Jul 26]. Available from:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3933585/pdf/12248_2014_Article_9570.pdf
28. Gordon J. Bioequivalence general consideration –WHO [Internet]. Copenhagen: WHO; 2016 May 16-19 [cited 2019 Jul 26]. Available from:
https://extranet.who.int/prequal/sites/default/files/documents/2-4_Bioequivalence.pdf
29. Huang X, Zhang S. Journal of drug design, development and therapy; Bioequivalence of two quetiapine extended release tablets in Chinese healthy volunteers under fasting and fed conditions and effects of food on pharmacokinetic profiles [Internet]. 2018 Nov 14 [cited 2019 Aug 22]. Available from:
https://www.dovepress.com/bioequivalence-of-two-quetiapine-extended-release-tablets-in-chinese-h-peer-reviewed-article-DDDT
30. Registering new drugs: The African context. Health policy division the George Institute for International Health [Internet]. 2010 Jan [cited 2019 Aug 10]. Available from:
http://apps.who.int/medicinedocs/documents/s17764en/s17764en.pdf
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How to Cite
Patel, P., J. Badjatya, and M. Hinge. “Comparative Study of Regulatory Requirements of Drug Product in Emerging Market”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 3, Sept. 2019, pp. 48-62, doi:https://doi.org/10.22270/ijdra.v7i3.350.