Regulatory Submission for Drug Approval in North East Asian countries: Hong Kong, South Korea and Taiwan

  • Juhi Padh
  • Ankita Patel
  • Vinit Movaliya
  • Khushboo Vaghela
  • Niranjan Kalanki
  • Maitreyi Zaveri

Abstract

Asia is the third largest Pharmaceutical market in the world after North America & Western Europe. Based on the current scenario of the Pharmaceutical market in the developing countries of Asia& Asian countries emerging as strong market especially North & South East Asia. Due to increasing health care market & trends at global level , countries like china, South Korea, Taiwan, Japan, Hong Kong& many other North east Asian countries are consider as fastest growing & emerging Pharmaceutical market are emerging as fast growing Pharmaceutical market at global level. Looking at this increase in market trade this North East Asian countries have set up their own requirements for product to be places in their market. This topic while look out and mark the regulatory requirements which are necessary for the product to get marketed in developing north East Asia countries like Hong Kong, South Korea & Taiwan. It will provide relative guidance regarding regulatory framework & regulatory submission requirements, registration process, regulatory filling etc. in these three developing countries of North East Asia. The article is brief overview of registration process of NDA filling, Generic Filling & renewal process including dossier requirements & submission in Hong Kong, South Korea& Taiwan .It will provide the basic knowledge of Online registration via PRS 2.0, MFDS & TFDA.

Keywords: Emerging Pharmaceutical Market, regulatory filing, NDA, Generic filing, PRS 2.0, MFDS, TFDA

Downloads

Download data is not yet available.

References

1. WHO, Genewa. How Pharmaceutical Systems are organized in Asia and the Pacific. Genewa: WHO;2018 Jan 31
2. Investment, A. F. O. R. Selecting a Pharmaceutical company from northeast Asia for investment; 2012.p.1–8.
3. OIC. Pharmaceutical Industry in OIC Member Countries, Production, Consumption and trade [Internet]. Sesric, 2011 [cited 2023 Jan 05]. Available from:
http://www.sesric.org/files/article/433.pdf
4. Badjatya JK. OVERVIEW OF DRUG REGULATORY AFFAIRS AND REGULATORY PROFESSION. Int J Drug Reg Affairs [Internet]. 2013Feb.5 [cited 2023Jan.2];1(1):1-. Available from:
https://ijdra.com/index.php/journal/article/view/1
5. Paek, H.-J., Lee, H., Praet, C. L. C., Chan, K., Chien, P. M., Huh, J., & Cameron, G. T. Pharmaceutical Advertising in Korea, Japan, Hong Kong, Australia, and the US. Health Communication Research. 2011;3(1):1-63.
6. Sapra A, Lenin B & Jain K. New Drugs and Clinical Trials Rules, 2019 – A Regulatory Overview. Regulation on Fees for Pharmaceutical Approval [Internet]. 2019 Jul 31 [cited 2023 Jan 06]. Available from:
https://corporate.cyrilamarchandblogs.com/2019/07/new-drugs-clinical-trials-rules-2019-regulations-india/
7. Pharmacy and Poisons Board of Hong Kong. Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity. Hong Kong: PPB; 2023 Feb.
8. Regulation on the Renewal of Marketing approval for Drug Products. 2020 Jul; 1(i):1–6, 1-13.
9. Terms and conditions for the use of pharmaceuticals registration system 2.0 (PRS2.0). (n.d.). [Internet]. drugoffice.gov.hk; 2019 Dec [cited 2023 Jan 06].Available from:
www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/PRS2.0_TC_en_2016.04.01_v1.2.pdf
10. Office, D. (2015). Application user manual for the pharmaceuticals registration of the department of. 0(October). [Internet]. drugoffice.gov.hk; 2015 [cited 2023 Jan 06].Available from:
https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/PRS2_User_Manual_Eng_v1.0.pdf
11. Epstein, R. Growth of the Asian health-care market: global implications for the pharmaceutical industry. Nat Rev Drug Discov 6. 2007;785–792.
https://doi.org/10.1038/nrd2360
12. Guidance Notes on New On-line User Account Registration for Pharmaceuticals Registration [Internet]. drugoffice.gov.hk; 2015 [cited 2023 Jan 06].Available from:
https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/PRS2_User_Manual_Eng_v1.0.pdf
13. Regulation on Approval for Investigational New Drug Application of Drugs [Internet]. drugoffice.gov.hk; 2019 [cited 2023 Jan 06].Available from:
https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Guidance_Notes_en_Version.pdf?v=xvweggsj
Source
14. Ministry of Food and Drug Safety. Regulation on Designation of Orphan Drugs [Internet]. mfds.go.kr; 2019 [cited 2023 Jan 06].Available from:
https://www.mfds.go.kr/eng/brd/m_18/view.do?seq=71453
15. Regulation for Pharmaceutical Approvals, Notifications and Reviews. 1(2018). [Internet]. mfds.go.kr; 2020 [cited 2023 Jan 06].Available from:
https://www.mfds.go.kr/eng/brd/m_18/down.do?brd_id=eng0003&seq=71512&data_tp=A&file_seq=1
16. Yeung, A. Hong Kong. Angels without Borders: Trends and Policies Shaping Angel Investment Worldwide; 2015.p.91–98.
17. Asia-Pacific Economic Cooperation (APEC). Drug Approval System of Chinese Taipei (Chemical Products). [Internet]. apec; 2015 Nov [cited 2023 Jan 06].Available from:
https://www.apec.org/meeting-papers/annual-ministerial-meetings/2015/2015_amm
18. Ministry of Food Drug and Safety. Guide to Drug Approval System in Korea [Internet]. mfds.go.kr; 2017 [cited 2023 Jan 07].Available from:
https://www.mfds.go.kr/eng/wpge/m_17/denofile.do
19. Reddy, K. N., & Vasantharaju, S. G. Comparison of Regulatory Requirements for Filing Drug Master File (DMF) in Emerging Markets - China, Brazil & South Korea. Applied Clinical Research, Clinical Trials and Regulatory Affairs. 2019;7(1):71–81.
https://doi.org/10.2174/2213476x06666190916122404
20. Parasiya S, Balamuralidhara V, Kumar PT, Gujarati R, Shukla A, Kshatri V. A PARADIGM SHIFT IN DRUG REGULATIONS IN TAIWAN. Int J Drug Reg Affairs [Internet]. 2014Jun.6 [cited 2023Jan.2];2(2):1-. Available from:
https://ijdra.com/index.php/journal/article/view/8
21. Yang, Y. T., Huang, H. W., Chen, Y. T., Chiang, Y. M., &Tzou, M. C. Regulation of New Drug Approval in Taiwan. Therapeutic Innovation and Regulatory Science. 2016;50(5)602–608.
https://doi.org/10.1177/2168479016640317
Statistics
123 Views | 1214 Downloads
How to Cite
Padh, J., A. Patel, V. Movaliya, K. Vaghela, N. Kalanki, and M. Zaveri. “Regulatory Submission for Drug Approval in North East Asian Countries: Hong Kong, South Korea and Taiwan”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 2, June 2023, pp. 17-29, doi:10.22270/ijdra.v11i2.575.

Most read articles by the same author(s)

1 2 > >>