Policy interpretation of pilot program of drug listing license holder system (2)

Source: CFDA 2016-9-29 1 Does the scope of pilot drugs include APIs? The scope of pilot drugs includes APIs of corresponding categories or situations 2、 Does the pilot drug range need to be met at the same time? No need, if the drug variety meets one of the "scope of pilot drugs", you can apply to participate in the pilot 3、 Can class 2 monoclonal antibodies of therapeutic biological products apply for the pilot project? If the drug to be declared is a new drug, it can be considered to apply for research and development according to the first and seventh categories of biological products for treatment; if the drug to be declared is a domestic listed variety, it can be considered to apply for research and development according to biological similar drugs 4、 Can the applicant submit registration application for different drug varieties in different pilot provinces (municipalities directly under the central government)? In the pilot work, the applicant (holder) is subject to territorial management During the pilot work, the applicant can only choose one pilot province to submit the application 5、 Can foreign R & D institutions established in China become applicants? Drug R & D institutions established in accordance with the law and able to bear independent responsibilities in the Pilot Administrative Region may become applicants Six Can foreign scientific researchers who hold the permanent residence permit for foreigners and work in China become applicants? may not 7、 Can the applicant (holder) be multiple entities (i.e Joint Declaration)? During the pilot work, the applicant and holder of the listing license are only one subject in principle 8、 How to understand the "drug manufacturing enterprises in the Pilot Administrative Region shall follow the relevant provisions of the holders in this plan" in the pilot plan? Can drug manufacturers apply to participate in the pilot work? Pharmaceutical production enterprises in the pilot administrative areas may apply to participate in the pilot work 9、 Does the drug manufacturer, as the holder, need to have the production license scope corresponding to the varieties it holds? Unwanted If it is produced by itself, it shall have corresponding qualification 10、 What are the specific requirements of the pilot work for the certification certificate of the pharmaceutical production quality management standard of the entrusted manufacturing enterprise? For APIs and biological products, when applying, the relevant entrusted production enterprises shall prepare in the workshop meeting the GMP requirements, and the preparation process shall strictly follow the GMP requirements; after the application for listing license is approved, the relevant entrusted production enterprises can apply for GMP based on the approval documents of pilot varieties Certification: relevant products can be produced and sold only after passing the certification; if the entrustment relationship is cancelled, and the GMP certificate or production scope of the entrusted production variety is only related to the variety, the corresponding GMP certificate or production scope of the variety shall be withdrawn or reduced by the provincial drug supervision and administration department where the entrusted production enterprise is located For the pilot drug varieties other than APIs and biological products, when applying, the relevant entrusted production enterprises shall hold GMP certification covering the scope of corresponding dosage forms 11、 Can the holder entrust multiple entrusted manufacturing enterprises to produce pilot drugs at the same time? Yes, but the holder shall submit relevant technical validation data to ensure the consistency of quality and efficacy of drugs from different places of origin 12、 Can the applicant (holder) entrust a third party to carry out drug quality supervision? Yes, but the relevant entrustment does not exempt the applicant (holder) from its obligations and responsibilities 13、 Among some drugs approved for marketing before the implementation of the pilot program, how can the applicant apply for participating in the pilot program for the drugs that pass the consistency evaluation of quality and efficacy? For the drugs that pass the consistency evaluation of quality and efficacy and meet the requirements of the pilot work, the drug manufacturer may apply to become the holder in accordance with the procedures specified in the pilot program 14、 If the varieties that have obtained the approval for clinical trials of drugs belong to the scope of pilot drugs, can the applicant apply for changing (adding) the approval for clinical trials? Those meeting the requirements of the pilot work may apply for, and at the same time submit the termination agreement or cooperation contract signed by the relevant subjects In view of the current record management system for the bioequivalence test (be test) of chemical generic drugs, the approval documents for the corresponding clinical trials of Category 3 and category 6 of the original registration classification of chemical drugs will not be approved for relevant changes 15、 Is the approval subject of the pilot work the provincial drug administration or the food and Drug Administration? After the provincial drug administration where the applicant is located carries out the acceptance work and puts forward the review opinions, it shall be submitted to the food and Drug Administration for review and approval 16、 Is it necessary for the applicant to apply for participating in the pilot project at the same time for the application of APIs and preparations declared by related parties? Unwanted The applicant may choose to apply separately for the participation of the drug substance or preparation in the pilot work 17、 If the holder is a pharmaceutical production enterprise, can he apply to entrust the entrusted production enterprise to produce the pilot drug varieties while producing by himself? Yes, but the holder shall submit relevant technical validation data to ensure the consistency of quality and efficacy of drugs from different places of origin