A Comparative Analysis and Reflection on the PIC/S GMP Annex for Herbal Medicinal Products Production with the Chinese GMP Appendices for Traditional Chinese Medicine Decoction Pieces and Preparations,and Related Regulations
Objective:To identify the advantages and disadvantages of the regulations related to the production of traditional Chinese medicine (TCM) by conducting a benchmarking study on the annex of PIC/S GMP for herbal medicine production,and to provide a theoretical basis for China's smooth accession to the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Methods:A comprehensive comparison was conducted among Chinese GMP decoction pieces,Chinese medicinal preparations annex,relevant regulations and the PIC/S GMP annex for Herbal Medicines production. An analysis and discussion were carried out on certain advantages and differences. Results:The requirements of China's GMP appendices for TCM decoction pieces and preparations,as well as related regulations,were essentially consistent with those of the PIC/S GMP annex for Herbal Medicines in all aspects. Moreover,China's TCM regulatory regulations were more comprehensive and specific in terms of plant and facilities and equipment,personnel,confirmation and verification,production management,and quality control and other requirements compared to the PIC/S GMP Herbal Medicines. Conclusion:China's relevant laws and regulations related to TCM production have a solid foundation and already meet the requirements of the PIC/S GMP annex for Herbal Medicines. Moving forward,it is essential to maintain confidence,clarify the direction,and further refine the regulatory requirements for TCM production in China.
Pharmaceutical Inspection Co-operation Scheme (PIC/S)Good Manufacture Practice (GMP)annex for Herbal Medicinal Products Productionstraditional Chinese medicine decoction piecestraditional Chinese medicine preparations
万方数据
维普
