Regulatory control of Chinese Proprietary Medicines in Singapore.
In Singapore, there has been a growing public interest in traditional Chinese medicine (TCM), which plays an important role in the healthcare system. With effect from 1 September 1999, the control on Chinese Proprietary Medicines (CPM) was implemented in three phases over a span of 3 years. Under the CPM regulatory framework, CPM importers, wholesalers, manufacturers and re-packers must be licensed and CPM products assessed and listed by the health authority before they are allowed for sale. Product assessment is based on the criteria of safety and quality which include limits of toxic heavy metals and microbial contents. During the 3-year CPM listing exercise, irregularities were detected, including intrinsic toxicity, adulteration, substitution, contamination, misidentification, non-traditional and/or inappropriate usage, incorrect preparation, inappropriate labelling, exaggerated claims and/or advertising. The full implementation of CPM control by September 2001 saw the listing of 7943 CPM products and brought about an improvement in the quality and safety of CPM in Singapore as well as the removal of sub-standard, fake/imitation and adulterated products. The standards of practices by local CPM dealers have also been raised. These improvements have, in turn, increased the level of public confidence in CPM products in Singapore.
Yee
Shen-Kuan
SK
Centre for Pharmaceutical Administration, Health Sciences Authority, Singapore, Singapore.
Chu
Swee-Seng
SS
Xu
Yi-Min
YM
Choo
Peck-Lin
PL
D004348:Drug Labeling; D033161:Government Regulation; D007880:Legislation, Drug; D008516:Medicine, Chinese Traditional; D011786:Quality Control; D012449:Safety; D012846:Singapore