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


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


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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.

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