China Strengthens Regulation of CM Injectables
State Food and Drug Administration (SFDA) launched the safety re-evaluation of CM injectables on 16 July 2009 to raise safety, efficacy and quality. Mr Wu Zhen, Deputy Director of SFDA, emphasized that this re-evaluation aimed at upgrading and improving CM injectables in addition to eliminating sub-standard ones – a crucial element for further advancement of the CM industry.
To address safety concerns through auditing of production and quality control processes
SFDA has compiled a document "Essentials: Safety Re-evaluation of CM injectables" (www.sfda.gov.cn/gsyjb09359/f1.rar) to raise production and quality control standards of CM injectables. Manufacturers should conduct internal audit on production and quality control to sort out potential safety risks and problems, and formulate necessary precautions. For those who cannot manage safety risks in production and quality control, they should stop manufacturing or rescind their drug approval certificates. Manufacturers should conduct prompt investigation upon receiving complaints on adverse reaction or poor quality of CM injectables. It is also the responsibility of manufacturers to provide in product inserts appropriate product uses and safety information including possible adverse reaction, incompatibility, drug interaction and precautions for ensuring safe clinical use of CM injectables. Provincial drug administration departments would collect audit check reports and submit to SFDA before 31 December 2009.
Integrated evaluation to ensure safety, efficacy and quality
Besides, SFDA has compiled the "Safety Re-evaluation of CM injectables - Technical Specification" (www.sfda.gov.cn/gsyjb09359/f2.rar) for manufacturers to follow. It will then conduct in-depth audits on various categories including the production status, clinical usage, adverse effect, and pharmaceutical standards & testing. SFDA requires CM manufacturers to proactively rescind the manufacturing licenses of those injectables which have gone out of production for a long time. For those products with inappropriate formulation, uncertain efficacy, safety and quality assurance, SFDA will conduct risk assessment on selected key items or rescind product licenses. The first batch of CM injectables proposed to be reviewed are Shanghuanglian injectable (made up of Flos Lonicerae Japonicae, Radix Scutellariae, and Fructus Forsythiae) and Shenmai injectable (made up of Radix Et Rhizoma Ginseng Rubra and Radix Ophiopogonis). For quality control and technical requirements, please refer to www.sfda.gov.cn/gsyjb09359/f1.rar and www.sfda.gov.cn/gsyjb09359/f2.rar
Speeding up standard advancement & assuring product quality
Manufacturers of CM injectables should follow specified technical requirements and actively conduct research of quality standards on raw materials, intermediates and final injectables to achieve batch-to-batch consistency and high internal control standards. For injectables with multiple suppliers or manufacturers, SFDA encourages collaborative research among manufacturers, R&D units and industry associations to attain high quality of products. Improvement of CM injectables standards is a key priority for SFDA. With inputs from pharmaceutical testing institutes and manufacturing enterprises, national standards of CM injectables will be disseminated soon. For injectables containing Chinese Materia Medica with uncertain origin or source of supply which cannot be manufactured according to current national production standard, their original national product standards will be removed.
Source:
State Food and Drug Administration www.sda.gov.cn |
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