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


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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:10.22270/ijdra.v7i1.297.

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