First, all kinds of medical institutions at all levels should cooperate with the recall of drugs containing valsartan, the raw material of Huahai Pharmaceutical, in accordance with the requirements of the State Administration of Medical Products.
Second, all kinds of medical institutions at all levels shall not use drugs containing raw materials of valsartan of Huahai Pharmaceutical Co., Ltd. involved in the recall in the diagnosis and treatment of diseases, but may use other drugs containing raw materials of valsartan not involved in the recall or choose other drugs for treatment. In this process, medical personnel should take effective measures to ensure medical quality and safety.
Three, all kinds of medical institutions at all levels should cooperate with the recall, stop using the relevant data information of drugs including valsartan and Huahai Pharmaceutical involved in the recall, and report to the local health and family planning administrative department and drug supervision department in a timely manner.
General Office of National Health and Wellness Committee
July 30, 1965 438+08
On July 29th, the spokesperson of the State Pharmaceutical Products Supervision Administration introduced the situation that trace N- nitrosodimethylamine (NDMA) impurities were detected in the raw material of valsartan of Zhejiang Huahai Pharmaceutical Co., Ltd. (hereinafter referred to as Huahai Pharmaceutical).
On July 6th, Huahai Pharmaceutical reported to the State Administration of Pharmaceutical Products that trace N- nitrosodimethylamine (NDMA) impurities were detected in raw materials exported to valsartan, and voluntarily disclosed relevant information to the public according to relevant regulations and requirements. After the impurities were detected, Huahai Pharmaceutical immediately suspended the release and delivery of all valsartan raw materials in the domestic and foreign markets, and initiated active recall measures. The current raw material process of this enterprise was approved by the European Drug Administration (EMA) and the US Food and Drug Administration (FDA) on 20 12 and 20 13 respectively. As of July 23rd, Huahai Pharmaceutical has completed the recall of all APIs in China.
Since July 6th, the State Administration of Medical Products has kept close communication and contact with EMA in Europe and FDA in the United States, paid close attention to the announcements and trends of risk assessment issued by international regulators in time, and organized experts to carry out risk assessment. Toxicological data show that the maximum daily intake limit of NDMA is 0. 1μg, which is equivalent to the provisional reference limit of EMA of 0.3ppm (calculated by taking 320mg valsartan daily). According to the above-mentioned limit value, all seven domestic manufacturers of valsartan raw material drugs (including Huahai Pharmaceutical) conducted a risk investigation. Except NDMA impurities of Valsartan API from Huahai Pharmaceutical, the NDMA impurities of Valsartan API from other domestic manufacturers were all below the limit or not detected.
Huahai Pharmaceutical has 6 pharmaceutical manufacturers involved in the use of valsartan raw materials. Valsartan capsules (National Medicine Zhunzi H20 10352 1) produced by Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd. have not yet left the factory, and the NDMA of products listed by other five manufacturers exceeds the standard. They are valsartan hydrochlorothiazide capsules of Chongqing Kangkeer Pharmaceutical Co., Ltd. (National Medicine Zhunzi H20080097), valsartan dispersible tablets of Hainan Huanglong Pharmaceutical Co., Ltd. (National Medicine Zhunzi H20050508), valsartan dispersible tablets of Harbin Sanlian Pharmaceutical Co., Ltd. (National Medicine Zhunzi H2006 1058) and valsartan hydrochlorothiazide dispersible tablets of Jiangsu Wang Ao Pharmaceutical Co., Ltd. (National Medicine Zhunzi H).
The State Administration of Pharmaceutical Products has asked all provincial food and drug supervision departments to urge relevant preparation manufacturers to take recall measures, and disclose relevant recall information on the websites of five manufacturers, including the contact numbers of the enterprises responsible for the recall. In order to facilitate the public to know in time whether the Valsartan drugs in use are within the scope of recall, five manufacturers cooperated with information technology companies to launch the code scanning inquiry function at 22: 00 on July 26th, 20 18, and can realize instant inquiry by scanning the product traceability code through the mobile APP. Please refer to the enterprise website for details.