Updated on 17 September 2013
Due to population size and overall health-spend, the potential for medicine sales in Malaysia is very small compared with many other countries in the Asia Pacific. Unlike India, China, South Korea, and Taiwan, there is no regulatory requirement to include local patients or to conduct clinical trials in Malaysia in order to gain marketing approval in the country. The financial costs associated with conducting clinical trials in Malaysia are very competitive. The Independent Ethics Committee (IEC) and regulatory approval processes in Malaysia are conducted in parallel and are quite straight forward. Submission dossiers can be in English (with the exception of subject materials such as informed consent forms which also need to be in Chinese and Malay) and there is a central IEC which covers all government hospitals and which meets every fortnight. The time-lag between IEC and regulatory dossier submission and investigator site initiation in Malaysia is typically less than three months. In contrast, in China and India the time-lag and processes are not only very much slower, but also inconsistent and unpredictable.
Although there is no national template for clinical trial agreements (CTAs), the process for review and sign-off of CTAs in Malaysia is quite fast compared to other countries in the Asia Pacific. On the other hand, sponsors can expect to pay a CTA review fee of up to $1,200 (MYR 4,000). One of the most convincing arguments for conducting clinical trials in Malaysia is quality. Not only is it mandatory for investigators in Malaysia to hold Good Clinical Practice (GCP) certification, the certification can only be obtained by attending a three-day ministry of health approved workshop and then passing a formal exam. Actually, the majority of investigator site staff are GCP-certified, so are most clinical research associates in the country.
Malaysia has a high incidence of first-world diseases, transparent review processes, short start-up timelines, lower financial costs, and above all, experienced investigator teams delivering high quality clinical research.