Decision of the State Council on Amending the regulations for the implementation of the drug administration law of the people's Republic of China

Source: CFDA 2016-3-3 recently, Premier Li Keqiang signed the 666 Decree of the State Council of the people's Republic of China, promulgated the decision of the State Council on amending some administrative regulations, including the regulations for the implementation of the drug administration law of the people's Republic of China As a continuation of the state's simplified regime, this amendment can also be enjoyed by small partners in the pharmaceutical industry I sorted out the changes for you For the establishment of a drug manufacturing enterprise, the sponsor shall apply to the drug regulatory department of the people's Government of the province, autonomous region or municipality directly under the central government where the proposed enterprise is located The pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government shall, within 30 working days from the date of receiving the application, organize the acceptance in accordance with the conditions for opening up as stipulated in Article 8 of the pharmaceutical administration law; if the acceptance is qualified, a pharmaceutical production license shall be issued Article 3 the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government and the pharmaceutical supervisory and administrative organs of cities divided into districts shall be responsible for organizing the certification work of pharmaceutical trading enterprises Pharmaceutical trading enterprises shall, in accordance with the implementation measures and steps prescribed by the pharmaceutical supervisory and administrative department of the State Council, pass the certification of the pharmaceutical trading quality management regulations organized by the pharmaceutical supervisory and administrative department of the people's Government of a province, autonomous region or municipality directly under the central government or the pharmaceutical supervisory and administrative organ of a city divided into districts, and obtain the certification certificate The format of the certification certificate of the code for the quality control of pharmaceutical trading shall be uniformly prescribed by the pharmaceutical supervisory and administrative department under the State Council "The newly established drug wholesale enterprises and drug retail enterprises shall, within 30 days from the date of obtaining the drug trade license, apply to the drug regulatory department or the drug regulatory agency that has issued the drug trade license for the certification of the drug trade quality management standard The pharmaceutical supervisory and administrative department or agency accepting the application shall, within three months from the date of receiving the application and in accordance with the provisions of the pharmaceutical supervisory and administrative department under the State Council, organize the certification of whether the drug wholesale enterprise or the drug retail enterprise applying for certification conforms to the "standards for the quality management of drug marketing"; if it passes the certification, the certification certificate shall be issued " Article 13 of the original "the drug regulatory body accepting the application for drug retail enterprise certification shall, within 7 working days from the date of receiving the application, transfer the application to the drug regulatory department of the people's Government of the province, autonomous region or municipality directly under the central government that is responsible for organizing the certification of drug trading enterprises." To be deleted Where a change is made to the items specified in the approval documents and their annexes for the development of new drugs, the production of drugs and imported drugs, a supplementary application shall be submitted to the drug regulatory department under the State Council; where the drug regulatory department under the State Council meets the requirements after examination, it shall be approved Where the internal quality of a drug is not changed, a supplementary application shall be submitted to the drug regulatory department of the people's Government of the province, autonomous region or municipality directly under the central government; where the drug regulatory department of the people's Government of the province, autonomous region or municipality directly under the central government meets the requirements after examination, it shall be approved and reported to the drug regulatory department of the State Council for the record The supplementary application items that do not change the internal quality of drugs shall be formulated by the drug regulatory department under the State Council Article 42 of Article 32 is replaced by Article 41, and a paragraph is added as the second paragraph: The re registration of the drug approval number shall be examined and approved by the drug regulatory department of the people's Government of the province, autonomous region or municipality directly under the central government and reported to the drug regulatory department of the State Council for the record; the re registration of the import drug registration certificate and the drug product registration certificate shall be examined and approved by the drug regulatory department of the State Council To amend the deleted part of Article 41, delete "the applicant shall go through the change registration formalities at the administrative department for Industry and commerce according to law with the changed drug production license" in Article 4 For drug wholesale enterprises and drug retail enterprises, delete "the sponsor shall register with the administrative department for Industry and Commerce in accordance with the law" in Article 11 Delete "the applicant shall register with the administrative department for Industry and Commerce in accordance with the law with the drug trade license" in Article 12 Delete "the applicant shall go through the change registration formalities in the administrative department for Industry and Commerce in accordance with the law with the changed drug trade license" in Article 16 Delete Article 32 Original: Article 32 for the production of drugs with the standard of trial period, an application for becoming a full-fledged drug shall be submitted three months before the trial period expires in accordance with the provisions of the drug regulatory department under the State Council; the drug regulatory department under the State Council shall apply for becoming a full-fledged drug 12 months after the trial period expires Within six months, the standards for the trial period shall be reviewed, and those meeting the requirements for becoming a full-fledged drug regulatory authority under the State Council shall be converted into formal standards; if the application for becoming a full-fledged drug regulatory authority under the State Council is not submitted within the time limit of the trial standards or the original trial standards do not meet the requirements for becoming a full-fledged drug, the drug regulatory authority under the State Council shall revoke the trial standards and the approval number of the drugs produced according to the trial standards 。 Delete articles 48, 49, 50, 51 and 75 Article 48 The State shall apply government fixed prices, government guided prices or market regulated prices to drug prices For the drugs listed in the national basic medical insurance drug catalogue and those with monopolistic production and trade outside the national basic medical insurance drug catalogue, the government's pricing or government's guiding price shall be implemented; for other drugs, the market adjusted price shall be implemented Article 49 for drugs priced and guided by the government in accordance with the law, the competent price department of the government shall, in accordance with the principles stipulated in Article 55 of the drug administration law, formulate and adjust the prices Among them, when formulating and adjusting the sales prices of drugs, the control over the average sales expense rate, sales profit rate and circulation difference rate of the drug society shall be reflected The specific pricing methods shall be formulated by the competent price department of the State Council in accordance with the relevant provisions of the price law of the people's Republic of China (hereinafter referred to as the "price law") Article 50 after the prices of drugs that are set by the government and guided by the government have been set in accordance with the law, the competent price department of the government shall, in accordance with the provisions of Article 24 of the price law, publish and specify the date when the prices will be implemented in the designated publications Article 51 when formulating and adjusting the prices of drugs subject to government pricing and government guided pricing, the competent government price department shall organize experts in pharmacy, medicine, economics and other fields to evaluate and demonstrate the prices; when necessary, it shall listen to the opinions of drug production enterprises, drug trading enterprises, medical institutions, citizens and other relevant units and personnel.