Asian Journal Of Social Pharmacy

Abstract: Objective To summarize the registration characteristics of generic drugs in 10 Association of Southeast Asian Nations countries and to put forward some suggestions for pharmaceutical enterprises applying for generic drug registration with these countries. Methods Literature review and comparative analysis were conducted to study generic drug regulatory authorities, laws and regulations, registration process and registration documentation requirements in the 10 ASEAN countries. Results and Conclusion For drug regulatory authorities, Singapore and Indonesia have one level of setting; Thailand, Vietnam, Philippines, Cambodia, Brunei and Laos have two levels of setting; Malaysia and Myanmar have three levels of setting. The registration procedure contains preparation, submission, review, evaluation and the approval from regulatory authorities. The generic drug registration documents for the 10 countries must be in accordance with the ASEAN CTD. Chinese pharmaceutical enterprises should be familiar with generic drug registration laws and regulations, and the process in ASEAN countries so that they can accelerate the registration process and improve the success rate.

Key words: ASEAN (Association of Southeast Asian Nations), generic drug, registration