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Challenges in the Clinical Development Requirements for the Marketing Authorization of New Medicines in Southeast Asia

The views expressed in this article are the personal views of the author and may not be understood, interpreted, or quoted as being made on behalf of, or reflecting the position of, the MHRA and any other agencies or parties cited in this article.

A rapid growth of investment into clinical research and new drug development has manifested itself by an exponential increase of new products coming onto the worldwide market. The emerging pharmaceutical and biotech markets in Southeast Asia are believed to be extremely promising from a commercial point of view in the next decade. The unique position of the Asian market and the diversity in clinical research initiatives are linked with diverse regulatory requirements for clinical development and registration of new medicines. Some of these differences have an impact on timelines for marketing authorizations in South Korea, China, Thailand, Japan, Singapore, and other countries. One of the approaches to streamlining regulatory strategy in different countries is the initiation of multicountry international clinical trials trying to address requirements and allowing registration in several regional countries simultaneously. Increasing cooperation between South Asian countries in relation to regulatory requirements and clinical development will facilitate the registration of innovative medicines in this rapidly developing region of the world and enable improved cohesiveness between countries in a drug safety framework.

Key Words: Ethnic factors • harmonization • clinical trial • China • Japan

Address for reprints: Alex Kudrin, MBBS, MSc, PhD, MHRA, Market Tower, 1-Nine Elms Lane, London SW8 5NQ, UK; e-mail: alexkudrin{at}aol.com.

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