Enhancing Regulatory Control Of Chinese Proprietary Medicines (CPM)

20 Aug 2002

The Ministry of Health (MOH) will be enhancing the regulatory control of Chinese proprietary medicines (CPMs). From 1 Jan 2003, all CPMs will be required to carry an additional label on their packaging. In addition, with effect from 1 Jan 2004, only test reports issued by accredited laboratories will be recognised and accepted by the Health Sciences Authority (HSA). HSA also intends to stipulate that all local and overseas CPM manufacturers will be subject to periodic Good Manufacturing Practice audits in accordance with the international standard.

Difference in assessment of CPMs and Western medicines

The regulation of CPMs for safety and quality according to a risk assessment approach differs from the regulation of Western medicines for which safety, quality and efficacy can be scientifically assessed.

Compared to western drugs, CPMs are generally considered to be relatively less toxic because they usually contain naturally occurring constituents such as herbs in low individual concentrations, and in the case of traditional medicines because of long historical usage.

CPMs cannot be assessed in the same way as synthetic Western medicines because CPMs generally contain natural ingredients with complex chemical constituents which are difficult to identify, characterise and standardise. This is unlike synthetic Western medicines containing known chemical based substances that can be readily identified and assessed for purity or the presence of contaminants. In addition, effectiveness of CPMs cannot be evaluated to the same extent as synthetic Western medicines because scientific data to validate the effectiveness of CPMs is generally lacking.

Hence, CPMs are regulated for safety and quality according to a risk-based approach in line with the systems adopted by regulatory agencies in developed countries like the United States, Britain and Australia. HSA has reviewed the existing regulatory framework for CPMs in Singapore. Although CPMs cannot be regulated in exactly the same way as synthetic Western medicines, HSA will be introducing four additional measures to strengthen the regulatory regime for CPMs.

Additional labelling

Increasingly, CPMs now come in the form and packaging which is making it more difficult to distinguish them from synthetic Western medicine. To assist consumers to better differentiate CPMs from Western drugs, with effect from 1 Jan 2003, HSA will require all CPMs to conspicuously display the following label on the outer sales packs in both English and Chinese:

Allowed for sale as a Chinese Proprietary Medicine

Testing of CPMs

Under the existing regulatory requirement, CPM importers are required to submit test reports to HSA before the product can be imported into Singapore and for every subsequent batch imported. Though this is already more stringent than that of the US and UK which do not have pre-market assessment of CPM products, HSA will introduce additional measures to enhance the reliability of the test reports and expand the scope of testing on a risk-based approach.

With effect from 1 Jan 2004, HSA will require all tests on CPMs to be conducted by accredited laboratories, to ensure the reliability of test reports. HSA will facilitate the establishment of a panel of local and overseas accredited laboratories, in conjunction with the relevant international accreditation bodies.

At present, samples of CPMs are also regularly taken from the local market according to a risk assessment approach for laboratory testing under HSA's ongoing quality surveillance programme, which is part of its post-marketing monitoring system, to countercheck the compliance of CPM products.

The quality surveillance programme will be enhanced and strengthened gradually each year by increasing the size of sampling as well as increasing the risk assessment criteria based on new findings and information gained over time. The risk assessment criteria, which will be continually refined, are based on a variety of parameters which include product claims, history of use and inherent product properties (e.g. some ingredients are more susceptible to microbial or heavy toxic metal contamination), track records of the dealer and manufacturer.

Good Manufacturing Practice

In parallel with the recent development of Good Manufacturing Practice audit programmes for herbal medicines by the World Health Organisation and national drug regulatory authorities, HSA will be implementing an audit programme based on international standards for local and overseas CPM manufacturers whose products are intended for the Singapore market.

Since the commencement of CPM control with effect from 1 Sep 1999, all local manufacturers of CPM products have been subjected to GMP audits on a periodic basis by HSA. All licensed local CPM manufacturers have met most GMP requirements.

The Pharmaceutical Inspection Convention / Cooperation Scheme (PIC/S) GMP standard is the international GMP standard that will be used by HSA. HSA intends to stipulate that all CPM manufacturers, whether based locally or overseas, will be subject to periodic GMP audits in accordance with the PIC/S GMP standard. HSA would work with the industry to determine when this requirement can be introduced.

Conclusion

HSA is confident that these additional measures will raise the standards for safety and quality of CPMs sold here. However, the public must continue to be careful and vigilant when taking CPMs, and to consult doctors when adverse effects are experienced and/or symptoms persist.