影响已上市中药品种安全性的生产工艺因素及其监管建议

Production Technology that Have an Impact on the Safety of Marketed traditional Chinese Medicinal Products and Supervision Recommendations

作者参考相关文献,结合目前中药生产工艺研究状况及中药品种保护审评工作实践,就生产工艺对已上市中药品种安全性影响的有关问题进行了逐项分析。发现生产工艺过程、工艺变更及新技术的应用等因素都会对已上市中药品种的安全性产生一定影响,针对这些问题提出加强中药基础研究、建立高于现行质量标准的内控质量标准、加强工艺验证、利用中药品种保护制度进行品种改进提高等相应的监管建议。

Analysis has been made on the key factors in production processes that have an impact on the safety of marketed tradi-tional Chinese medicinal products based on literature research, current production situation, and practice of reviewing the protected products.It has been found that production process, technology changes, and novel technology all play certain role in safety of marketed traditional Chinese medicinal products.Therefore, the following recommendations have been made：to strengthen the fun-damental research, establish in-house quality control with higher quality standards than current national quality standards, strengthen validation of production processes, make better use of the protection system to improve quality of traditional Chinese me-dicinal products.