Interpretation of the new regulations on the implementation of the registration management of imported drugs
The "Decision on Adjusting the Relevant Matters Concerning the Registration and Administration of Imported Drugs" encourages the listing of new drugs to meet clinical needs. The State Food and Drug Administration has decided to make four major adjustments to the relevant matters concerning the registration and management of imported drugs. Corresponding answers have also been made to relevant issues. In order to encourage the listing of new drugs and meet clinical needs, CFDA recently issued the "Decision on Adjusting the Relevant Matters Concerning the Registration and Administration of Imported Drugs" (hereinafter referred to as the "Decision"). According to the Standing Committee of the National People's Congress, the State Council is authorized to conduct drug marketing approval in some places. The "holders' system pilot and related issues" "State Council's Opinions on Reforming the Medical Device Evaluation and Approval System for Drugs" (Guo Fa [2015] No. 44) requires adjustments to some aspects of the registration of imported drugs. The "Decision" stipulates that in addition to the prevention of biological products, the international multi-center drug clinical trials in China are allowed to carry out phase I clinical trials simultaneously, and the drugs for clinical trials should be registered overseas or have entered phase II or III. Requirements for clinical trials; after the completion of the international multi-center drug clinical trial in China, the applicant can directly submit an application for registration of the drug. The "Decision" also canceled the requirement that the new drug for chemical drugs and the innovative drugs for therapeutic biological products should obtain the marketing authorization of the country or region where the foreign pharmaceutical manufacturer is located when submitting the application for import clinical application or import listing. The "Decision" shall be implemented as of the date of promulgation. For applications for registration that have been accepted before the release and submitted for import clinical trials with international multi-center clinical trial data, in line with the requirements of the Drug Registration Management Measures and related documents, the import may be directly approved. . Order No. 35 of the State Food and Drug Administration The Decision of the State Food and Drug Administration on Adjusting the Relevant Matters Concerning the Registration and Administration of Imported Drugs was reviewed and approved at the State Council of the State Food and Drug Administration on June 20, 2017. It is hereby promulgated and will be implemented as of the date of promulgation. Decision of the State Food and Drug Administration on Adjusting the Relevant Matters Concerning the Registration and Administration of Imported Drugs According to the "National People's Congress Standing Committee's Decision on Authorizing the State Council to Launch the Drug Listing Permit Holder System and Relevant Issues in Some Places", "State Council's Opinions on Reforming the Approval System for Drug Medical Device Evaluation" (Guo Fa [2015] 44 No.), in order to encourage the listing of new drugs and meet clinical needs, the State Food and Drug Administration has decided to make the following adjustments to the relevant matters concerning the registration and management of imported drugs: 1. Conduct international multi-center drug clinical trials in China, allowing phase I clinical trials to be carried out simultaneously. Drugs for clinical trials should be registered overseas or have entered the requirements of Phase II or Phase III clinical trials, with the exception of preventive biological products. 2. After the completion of the international multi-center drug clinical trial in China, the applicant may directly submit an application for registration of the drug. When submitting an application for listing registration, the requirements of the Measures for the Administration of Drug Registration and related documents shall be implemented. 3. For the application of clinical trials for imported drugs, new drugs for chemical drugs, and innovative drugs for therapeutic biological products, the requirements for listing approval for the country or region where the foreign pharmaceutical manufacturer is located shall be removed. 4. For applications for registration that have been accepted before the issuance of this decision and submitted for clinical trials of imported drugs with international multi-center clinical trial data, in line with the requirements of the Drug Registration Management Measures and related documents, import may be approved directly. This decision is implemented as of the date of publication. If the relevant provisions of the relevant regulations on drug administration are inconsistent with this decision, it shall be implemented in accordance with this decision. policy analyzing "I. What are the scope of application of the "Decision" adjustment related matters?" The scope of application of the "Decision" to adjust the registration of imported drugs includes the application of the International Multi-Center Drug Clinical Trial (hereinafter referred to as MRCT), the new drug for chemical drugs, and the import and export registration of innovative drugs for therapeutic biological products. "II. What are the main items of the "Decision" adjustment compared with the current practice?" There are three main aspects to the adjustment of the Decision. The first is to allow simultaneous research and development declarations. The current "Regulations on the Administration of Drug Registration" (hereinafter referred to as the "Regulations") require that overseas applicants apply to the General Administration for the implementation of MRCT drugs, which should have been registered overseas or have entered Phase II or Phase III clinical trials. After the implementation of the "Decision", in addition to the prevention of biological products, it is allowed to carry out clinical trials in the same period in China and abroad. The second is to optimize the registration process. The MRCT declaration and review and approval in the "Regulations" is a relatively independent procedure. If an application for importing a drug for MRCT is required, it must be declared in accordance with the registration procedure for imported drugs. After the implementation of the "Decision", the application for import of drugs for MRCT is in compliance with the requirements of the "Regulations on the Administration of Drug Registration" and related documents, and an application for import registration may be directly filed. The third is to cancel the requirement for some imported drugs to be listed overseas. Specifically, for the introduction of a clinical application for import, a new chemical for importing a listing application, and an innovative pharmaceutical for a biological product for treatment, the requirement to obtain a marketing license for the country or region where the foreign pharmaceutical manufacturer is located should be removed. "3. Does Article 3 of the Decision "Cancel the requirement to obtain a listing permit for the country or region where the foreign pharmaceutical manufacturer is located" applies to the entire registration process?" "4. Is the application for the cancellation of the listing permit for the country or region where the foreign pharmaceutical manufacturer is located in Article 3 of the Decision applies to all applications for registration of imported drugs?" For the introduction of clinical applications for import, the application of new drugs for import and marketing, and the innovative drugs for therapeutic biological products, the requirements for listing approval for the country or region where the foreign pharmaceutical manufacturer is located shall be removed. For other drug registration applications, relevant information must still be provided in accordance with the relevant provisions of the Drug Registration Management Measures. "V. What is the definition of Article 3 of the "Decision" "New Drugs for Chemicals and Innovative Medicines for Biological Products for Treatment"?" The new chemical drug refers to the first and second categories of chemicals prescribed by the General Administration of the State Council on the Announcement of the Work Plan for the Reform of the Registration of Chemical Drugs (No. 51, 2016). Innovative medicine for therapeutic biological products means not at home and abroad. infrared thermometer gun,infrared thermometer best,infrared thermometer gun for human body,ear thermometer:thermometer Shenzhen Urion Technology Co., Ltd. , https://www.urionhealth.com