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SFDA Guidelines on Protection of Traditional Chinese Medicines
To carry forward the unique characteristics of traditional Chinese medicine (TCM), foster innovation and regulate the protection of mainland TCM species, State Food and Drug Administration (SFDA) recently issued Guidelines on the Protection of Traditional Chinese Medicines (the Guidelines). As pointed out in the press conference by Director of SFDA Department of Drug Registration Mr. Zhang Wei, the Guidelines highlighted the principles of TCM protection and lifted the standards for extension of protection period. The Guidelines is introduced with a long term view for sustained development. It consists of five parts including General Provisions, General Requirements, Primary Protection, Protection of Same Variety and Extension of the Protection Period.
Clearer Criteria, Greater Protection
The Guidelines clearly sets out the requirements of clinical evaluation as follows:
- Class 1 Protection: in compliance with Clause 6 of the Chinese Medicine Protection Regulation, the drug must be clinically proven to have achieved breakthrough in efficacy for the treatment of a particular disease, or can be used in the prevention or treatment of a special disease.
- Class 2 Protection: in compliance with Clause 7 of the Chinese Medicine Protection Regulation, clinical data must demonstrate the profound efficacy of the drug in application, and has distinctive edge over similar products.
In the area of innovation protection, the Guidelines stipulates the following evaluation criteria:-
- New dosage forms must be accompanied by testing results demonstrating that they are innovative and reasonable;
- Modified drugs must have distinctive edges over the original species in dosage amount and stability;
- Concoctions made up of Chinese medicine, natural drugs and chemical drugs need to demonstrate that the combinations are sensible and reasonable;
- Quality of raw materials must be stable and controllable, with traceable origin. Major ingredients should come from a designated source with stable supply. Processing methodology and standards need to be clearly stated for processed CM used in drugs.
- The effective component of single-ingredient drugs must be identified and managed by specific quality control mechanisms.
Reasonable Management Requirements for Same Variety
To address the issue of the protection for same variety, the Guidelines firstly stipulate that originators need to file Primary Protection application. The Guidelines then provides a clear definition for “Same Variety” to facilitate enterprises producing the same kind to apply for Protection of Same Variety. Thirdly, the Guidelines establish uniform quality standard requirements for primary protection and same variety and make sure they are assessed with the same criteria.
Tighter Controls on Extension of the Protection Period
The Guidelines emphasize that drugs applying for extension of protection period must satisfactorily prove their distinctive clinical efficacy for the targeted disease. In addition, applicants also need to complete the required improvement works and submit relevant information. It also needs to be demonstrated that significant improvements have been achieved in clinical, pharmacological, toxicological, pharmaceutical and other aspects. Issues of concern include traceable source and stable supply for CM raw materials, comprehensive monitoring for manufacturing process, controllable quality and standard, clearly-defined scope of application and instruction for use. By lifting the requirements for extension of the protection period, the quality of protected CM varieties will be continuously improved.
According to Mr. Zhang, there are 1257 drugs currently under protection, involving 1002 enterprises. Implementation of the Guidelines will address the problems of excessive protected varieties and eliminate some of the problems in Same Variety Protection. Mr. Zhang further emphasized that the Government would play a more active role in coordinating the efforts of different parties to advance the development of CM and ethnic medicine. SFDA will join hands with State Ethnic Affairs Commission, SATCM and other relevant parties to hold a conference in 2009 for the discussion of the future development of ethnic medicine.
Sources:
State Food and Drug Administration www.sfda.gov.cn
China News of Traditional Chinese Medicine www.cntcm.com.cn |
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