Goldfish injection enters the second comprehensive evaluation list

The re-evaluation of the safety evaluation of traditional Chinese medicine injections officially unveiled the second batch of comprehensive evaluation list. The State Food and Drug Administration (SFDA) recently issued the "Notice on Doing a Good Job of Reassessing the Safety of Traditional Chinese Medicine Injections in 2010" (hereinafter referred to as the "Notice"). It is clear that Houttuynia injection and Yujin injection are the second Batches comprehensively evaluate varieties and organize comprehensive evaluations.

The "Notice" requires that manufacturers should submit information on the pharmaceutical research part of Houttuynia injection and Yujin injection to the local drug regulatory authorities together with non-clinical and clinical research plans by December 31, 2010. After reviewing the data and verifying the production site and the research situation, the drug regulatory departments of each province (region, city) put forward an audit opinion and submit it to the Drug Evaluation Center of the State Bureau. After the pharmaceutical evaluation is passed, Houttuynia injection and Yujin injection can be clinically studied according to the clinical research plan. According to the person in charge of the Department of Drug Safety Supervision of SFDA, only the Houttuynia injection and Yujin injection that were re-evaluated can resume production, otherwise they will only be eliminated.

It is understood that the first batch of synthetically evaluated varieties were Shuanghuanglian Injection and Shenmai Injection. The pharmaceutical research work of related companies has been basically completed, and some provincial and municipal bureaus have reviewed and on-site verification of the reported pharmaceutical research data. In the "Notice", SFDA requires all provincial (municipal, district) drug regulatory authorities to complete the preliminary review of the pharmaceutical research data and non-clinical and clinical research plans for Shuanghuanglian Injection and Shenmai Injection submitted to the production enterprises as soon as possible and submit an audit. Opinions and submit the information to the National Bureau of Drug Evaluation. With regard to the submitted pharmaceutical research materials, the State Bureau will organize relevant units and experts to conduct pharmacy evaluation as soon as possible. After the pharmaceutical evaluation is passed, the manufacturer can carry out clinical research work in accordance with clinical research programs.

In the “Notice”, SFDA also requires drug regulatory agencies at all levels to strengthen the supervision and inspection of the production and quality control aspects of TCM injection manufacturing enterprises, control the origin of raw materials and auxiliary materials for TCM injections, process implementation, key process verification, and pyrogen control. , Aseptic assurance levels, etc. continue to follow-up inspections, production companies that have failed to meet the requirements or have assessed potential safety hazards will be ordered to stop production. And to guide production companies to carry out research in accordance with relevant requirements, through research to improve product quality and safety.