A critical view of harmonization of regulatory requirements for Generic Drug approval submissions in ASEAN countries

  • Jyoti Ghangas RPIIT College of pharmacy
  • Neha Jain
  • Anshuman Sinha


To ensure quality, efficacy, and safety of drugs is the prime objective of any country and respective drug regulatory authority. Countries have their own regulatory setup to ensure the proper execution of drug regulatory guidelines in their country. There are several regional organization in world, ASEAN is one of them. It is Association of Southeast nations. ASEAN is very well representing its countries on global platform. The step of harmonization of drug regulatory guidelines by ASEAN is seen as major step taken by an Asian regional organization.

ASEAN is an emerging market and every country has its own needs. As research and development sector is only developed in Singapore in ASEAN region so, generics emerge as a tool for other countries to fulfill UHC goals and Vision 2020 ASEAN. Every country has the different procedure for generic drug registration application approval. To clearly understand the procedure of generic drug registration application approval process we have gone through various guidelines and literature. There are 10 members in ASEAN i.e. Singapore, Malaysia, Thailand, Indonesia, Philippines, Brunei Darussalam, Laos PDR, Myanmar, Vietnam, and Cambodia. Each one’s generic drug approval process, requirements and effects on pharmaceutical trade after implementation of ACTD is explained in this research work. This research work also includes the statistical analysis and suggestions on how other countries and regional organization follow the model of ASEAN for drug regulatory harmonization procedure.

Keywords: ASEAN, Regulatory affairs, ACTD, UHC, Vision 2020 ASEAN, CTD, Generic drug approval, ACTR


Download data is not yet available.


1. Badjatya J.K. Overview of drug registration requirements for pharmaceuticals in emerging market. Journal of Drug Delivery and Therapeutics. 2013; 3(2): 227-232.
2. WHO | World Health Organization [Internet]. WHO; 2018 [cited 2019 Jan 11]. Available from:
3. Handoo S., Khera D., Nandi P., Sahu S., Arora V. A comprehensive study on regulatory requirements for development and filing of generic drugs globally. International Journal of Pharmaceutical Investigation. 2012; 2(3): 1-12.
4. Rodriguez V., Soeparwata A. ASEAN benchmarking in terms of science, technology, and innovation from 1999 to 2009. Scientometrics. 2012; 92(3): 549-73.
5. World Bank | World Bank [Internet]. World Bank; 2019 [cited 2019 Jan 11]. Available from:
6. Pankaj K., Duggal E., Budhwar P., Badjatiya J.K. Marketing authorization of generic drug: global issue and challenges International Journal of Drug Regulatory Affairs. 2013; 1(3): 1-6.
7. APAC Regulations and Approvals Expert Working Group. Identification and Clarification of the differences in Regulatory requirements between Asian Economies. Tokyo, Japan: Asia Partnership Conference of Pharmaceutical Associations (APAC); 2013: 1-118.
8. ASEAN. ACTR., [Internet]. The ASEAN Secretariat: Jakarta; 2016 Dec [cited 2019 Jan 15]. Available from:
9. Vaseem Akram M., Venketeshwarlu B., Ramaiah M., Nagabhushanam, Nagaarujuna D. Regulatory requirements for the registration of generic solid orals in USA, Singapore, Malaysia, and Thailand. JGTPS. 2014; 5(4):2225-32
10. The ASEAN Secretariat. ASEAN Statistical Yearbook. Jakarta: The ASEAN Secretariat; 2017: 1-280.
11. The ASEAN Secretariat. ACTD. Jakarta: The ASEAN Secretariat; 2016 .p. 4-198.
12. EMEA. CTD. London: EMEA; 2003: 1-26.
13. Health and Healthcare Systems in Southeast Asia - United Nations University [Internet]. Unu.edu 201: Japan; 2012 Apr 5 [cited 2019 Jan 19]. Available from:
14. ASEAN Statista. [Internet]. statista; 2018 [cited 2019 Jan 14]. Available from:
15. ASEAN [Internet]. ASEAN: Thailand; 2017 [cited 2019 Jan 14]. Available from:
14 Views | 15 Downloads
How to Cite
Ghangas, J., N. Jain, and A. Sinha. “A Critical View of Harmonization of Regulatory Requirements for Generic Drug Approval Submissions in ASEAN Countries”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 1, Mar. 2019, pp. 13-24, doi:https://doi.org/10.22270/ijdra.v7i1.297.

Most read articles by the same author(s)