Source: State Medical Products Administration In order to implement the "Opinions of The General Office of the State Council on Accelerating the Construction of an Important Product Traceability System" (Guo 'an Fa (2015) No. 95)，We will further improve drug quality and safety，According to the "Opinions of the Food and Drug Administration on Promoting the improvement of the traceability system of food and drug manufacturers" (Food and Drug Administration [2016] 122) and the Ministry of Commerce and other departments "Guiding Opinions on Promoting the construction of the Information Traceability System of Important products" (Shangxifa [2017] 53) and other relevant provisions，Now put forward the following guidance on the establishment of drug information traceability system。 […]

 Original: Ye Ling Pharmaceutical Economic News at the Shanghai forum of pilot joint procurement led by the National Medical Insurance Bureau on September 11，The requirements and rules of joint procurement are introduced，And announced the first batch of volume purchase catalog，A total of 33 varieties，Including rosuvastatin, tenofovir ester, cefuroxime axetil, etc., which have passed the consistency evaluation of 3 companies。11 cities (Beijing, Shanghai, Tianjin, Chongqing and Shenyang, Dalian, Guangzhou, Shenzhen, Xiamen, Chengdu, Xi 'an) (" 4+7 "), from [...]

Recently, Jiangxi Province issued a notice: the same variety of drugs through the consistency evaluation of more than 3 enterprises, did not pass the suspension of their online procurement qualifications。According to Mi Intranet statistics，As of August 16，There are 5 varieties (3 in 2017 national sales of more than 1 billion yuan) through the consistency evaluation of the number of enterprises reached 3，There are 112 enterprises involved，There are five varieties (four with national sales of more than 1 billion yuan in 2017) that are about to lock in the "1+3" pattern，There were 277 companies involved。The consistency evaluation policy is gradually clear, and the pace of enterprises has to accelerate, once 3 have been determined, those who have not passed are out, which means that [...]

7月12日，Notice of The General Office of the State Council on Adjusting the Composition of the Leading Group for Deepening the Reform of the Medical and Health System of The State Council (2018) No. 56)，The composition of the Leading Group for Deepening the Reform of the medical and health system (referred to as the "deep restructuring") has been adjusted，The group is headed by Vice Premier Sun Chunlan，The deputy leaders are He Lifeng, head of the National Development and Reform Commission, Ma Xiaowei, head of the National Health Commission, Liu Kun, Minister of Finance, Zhang Jinan, Minister of Human Resources and Social Security, Ding Xiangyang, deputy Secretary-General of The State Council, and Hu Jinglin, director of the Medical Insurance Bureau。 　　 　　According to the notice, the secretariat of the Leading Group is set up [...]

　　Article 30 of the Law of the People's Republic of China on Traditional Chinese Medicine stipulates: "For the production of compound Chinese medicine preparations derived from ancient classical prescriptions that meet the conditions prescribed by the State, only non-clinical safety research data may be provided when applying for drug approval numbers.。”6月1日，The State Medical Products Administration issued the Regulations on Simplified Registration and Approval of Compound Preparations of Ancient Classic Famous Chinese Medicines (hereinafter referred to as the "Regulations").，The conditions of simplified examination and approval, the qualification of the applicant, the declaration and release of the substance benchmark, the registration procedures and management requirements of classic famous prescription preparations, and the responsibilities of all relevant parties are explained in detail。 　　　　 &nbsp […]

      5月17日，In order to standardize and strengthen the review and approval information confidentiality management，To ensure the legal and efficient operation of drug review and approval，Notice of the State Drug Administration on the Implementation Rules for Strengthening the Confidentiality Management of Drug Review and Approval Information (hereinafter referred to as the Implementation Rules) (No. 27, 2018)，Relevant personnel and external experts engaged in drug registration acceptance, technical review, on-site verification, registration inspection, administrative approval and other review and approval activities are required，The awareness of confidentiality should be enhanced，Strictly abide by the confidentiality discipline，Strictly manage classified information，严防 […]

On September 5, the "Small press Conference for the preparation of the 2020 edition of Chinese Pharmacopoeia" was held in Beijing。The reporter was informed at the meeting that on the basis of considering the overall situation of national drug standards, the number of varieties contained in the 2020 edition of the pharmacopoeia is expected to reach about 6,400。Among them: about 220 varieties of traditional Chinese medicine, about 420 varieties of chemical drugs, 30 varieties of biological products, about 100 varieties of pharmaceutical excipients, and 30 varieties of pharmaceutical packaging materials, a total of about 800。 The reporter learned at the meeting that our country has successfully passed the special period of lack of medicine, and the preparation of pharmacopoeia has been focused on [...]