Registration Of Traditional Medicines In Malaysia


Ahmad bin Mahmud, The National Pharmaceutical Control Bureau Selangor, Malaysia


Trends in Traditional Medicine Research, Proceedings of the International Conference on the Use of Traditional Medicine & Other Natural Products in Health Care




traditional medicines, registration criteria, quality, safety and efficacy requirements


The gazetting of the Control of Drugs and Cosmetics Regulations in June 1984 marked the beginning of a systematic regulatory control on pharmaceutical products in Malaysia. The registration exercise of Traditional Medicines which started in 1992 comes under the third phase of the implementation of the said legislation. Taken positively, to the consumers, it could easure safety, quality and to certain extent the efficacy of Traditional Medicines, and to the industry, spur the modernisation process of local pharmaceutical industry of Traditional Medicines. In Malaysia, there are in the market 4 major groups of Traditional Medicines namely the Malay Traditional Medicines, Indian Traditional Medicines, Chinese Traditional Medicines and Western Traditional Medicines, each having its own distinctive group of commonly used herbal materials. The major problems faced by Traditional Medicines of all the four groups are firstly, the lack of clinical data to substantiate efficacy claims and secondly non-existence of standard for most herbal materials. Most local Traditional Medicines manufacturers are small scale and their manufacturing facilities in dire state. The implementation of registration exercise also means that the Ministry of Health or more specifically, the National Pharmaceutical Control Bureau has taken upon itself added responsibility to guide, coax and compel the local pharmaceutical industry of Traditional Medicines towards modernisation and ultimately the compliance with the requirement of Good Manufacturing Practice. It is hoped that given reasonable time-frame, technical guidance and support, a flourishing modern pharmaceutical   industry on Traditional medicines will emerge in Malaysia in the very near future.