Circular of the General Administration of the people's Republic of China on Soliciting Opinions on the decision of adjusting the registration and administration of imported drugs

  In accordance with the requirements of the opinions of the State Council on the reform of the review and approval system for pharmaceutical and medical devices (GF [2015] No 44), in order to encourage overseas unlisted new drugs to carry out clinical trials simultaneously at home and abroad after approval, shorten the time interval for listing at home and abroad, and meet the public's clinical needs for new drugs, the State Food and Drug Administration drafted the State Food and drug administration The decision of the General Administration of the people's Republic of China on adjusting the registration and administration of imported drugs (Draft for comments) is now open to the public for comments Before April 20, 2017, relevant units and people from all walks of life can give their opinions in the following ways: 1 Log in to the legal information network of the Chinese government (website: http://www.chinalaw.gov.cn) and enter the "opinion collection system for draft regulations" on the left side of the homepage to give their opinions and suggestions 2 Send the opinions to hxypc@cfda.gov.cn by email, and indicate the subject of the email: "opinions on adjusting the registration of imported drugs" Decision of the State Food and Drug Administration on adjusting the registration of imported drugs on March 17, 2017 (Draft for comments) Docx decision of the State Food and Drug Administration on adjusting the registration of imported drugs (Draft for comments) According to the opinions of the State Council on the reform of the review and approval system for pharmaceutical and medical devices (GF) 2015] No 44) requires that, in order to encourage overseas unlisted new drugs to carry out clinical trials at home and abroad simultaneously after approval, shorten the time interval for listing at home and abroad, and meet the public's clinical needs for new drugs, the following adjustments shall be made to the matters related to the registration and management of imported drugs upon the research and decision of the executive meeting of the State Food and Drug Administration: 1、 For international multi center drug clinical trials in China, the requirements for canceling the drug for clinical trials shall be that the drug has been registered abroad or has entered phase II or phase III clinical trials, excluding vaccine drugs 2、 For the international multi center drug clinical trials conducted in China, after the completion of the international multi center drug clinical trials, the application for drug registration can be directly filed; when the application for registration is filed, the requirements of the measures for the administration of drug registration and relevant documents shall be implemented 3、 For new chemical drugs and innovative drugs for therapeutic biological products that are applied for import, the requirement that the marketing license of the country or region where the overseas pharmaceutical manufacturer is located should be cancelled 4、 For those that have been accepted before the issuance of this decision, the registration application for exemption from import clinical trials shall be submitted based on the data of international multicenter clinical trials If the application meets the requirements, the import can be approved This decision shall be implemented as of If the registration management of imported drugs in the relevant regulations of drug supervision is inconsistent with this decision, this decision shall prevail.