Progressing CM standard development: New Chinese Pharmacopoeia (2010) in consultation
Chinese Pharmacopoeia (CP) is a collection of statutory and mandatory medicines standards and a reflection of contemporary quality control and development trends in medicines. With preparatory work commenced since 2007, the 9th edition of CP – CP (2010) – will be officially published in 2010. CP Commission is soliciting views online (www.chp.org.cn/index.asp) (in Chinese only) on 1174 items including Chinese medicinal species, Chinese material medica and decoction. CP(2010) embraces the following principles: “Science, Practicability & Standardisation”, “Quality control” and “Standard advancement”. The new CP attempts to cover all medicines listed in the country’s basic drug formulary and medical insurance reimbursement plan.
The 9th CP Commission was formally established in December 2007. It is responsible for formulating national medicines standards. The Commission consists of an executive committee and 25 sub-committees with 323 experts (including 25 academicians) specialising in clinical medicine, R&D, production, testing and management. Mr Shao Mingli (Deputy Minister of Health, Director-General of State of Food and Drug Administration, Chairman of CP Commission) emphasises the following principles in the compilation of the new CP: 1) upgrading medicines quality and safeguarding public health, 2) embracing tradition, development and innovation to enhance quality and international competitiveness of new drugs, 3) integrating science, practicability and standardisation, 4) maintaining high standards and keeping pace with international standards.
Major revisions on medicinal species standards, preparation and testing methods have been made in the new CP to achieve consistency in medicines quality control between China and other developed countries. This new edition of CP gathers advanced technology and international standards and advocates green testing which are less toxic, less polluted, resource-saving, environmental friendly, simple and practical, and will increasingly create international impact.
Progressing CM standard development
As pointed out by Mr Zhou Fucheng (Vice Secretary of CP Commission), by consolidating previous compilation experience, international pharmaceutical standards and output of on-going pharmaceutical research, the new CP is of high standard and valuable reference value. CP (2010) is compiled on the premises of science, advancement and authority. It reflects China’s capabilities in pharmaceutical industry, clinical medicine and testing technology, and its international influence.
With special emphasis on basic, systematic and standardisation research, the new CP incorporates the use of technology and methodology in formulating standards of Chinese materia medica and decoction. Thin layer chromatography (TLC) of all compiled items (excluding mineral drug) have been established for authentication purpose in CP (2010). Application of modern analytical technology in standardisation have been widely adopted in CP (2010), such as application of PCR method for authentication of animal drug like snake and herbal drug like Fritillariae Cirrhosae Bulbus. Other advanced technologies like liquid chromatography-mass spectrometry (LC-MS) have also been recommended for quality control and authentication. As technology advances, quality standardisation will gradually embrace chemical markers (e.g. bioactive and therapeutic ingredients) alongside multi-component identification and fingerprinting to support authentication.
Emphasising quality control and safety issues
Special attention is accorded to quality control and safety of medicines, especially those of high risk. Additional safety requirements and detection methods will be specified in CP (2010), including 1) detection of heavy metals and toxic elements on more items with increased batch size of testing, 2) requirements for conducting microbial tests, 3) abnormal toxicity and allergic reactions on items with partially-known chemical structures, 4) strict control of antibiotics in biological products, 5) control of adulterants in biological products, 6) specified limits of residue endotoxin in vaccines, 7) requirements and list of approved excipients.
Sources: (Courtesy translation from)
Chinese Pharmacopoeia Commission: www.chp.org.cn
China News of Traditional Chinese Medicine: www.cntcm.com.cn |
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