The medical website on June 1 

 

A, application of chemical classification of new registered information requirement of the active pharmaceutical ingredients of pharmaceutical information summary table "the preparation of pharmaceutical information summary table" the summary table of non-clinical research and the information of the clinical information summary table provided format, the catalog and project number can be modified? 

 

Answer: on May 4, 2016, the administration of information about release chemicals new registered segment reporting requirements (trial) circular no. 80 (2016), the attachment to declare the chemical new registration category requirements (try out) "in the declaration data writing instructions, information is based on the information in the summary table declaration data extraction, the content and data should be consistent with the declaration data, and indicate the corresponding declaration data under various projects and the page number. The format, directory, and project number of the main information summary table cannot be changed. Even if the corresponding project no relevant research data or information, also should keep, item number and name can be made under the "no related research content" or "not applicable". For the information submitted in the form of an attachment, it shall be noted under the corresponding terms "see appendix (the page number of the declared information"). 

 

What is the cover of the clinical trial report in the medical declaration data? 

 

Answer: basis "total bureau releases about chemical new registered classification declaration data requirements (trial) circular no. 80 (2016), the clinical test report with reference to the structure and content of chemical drugs in clinical trials report technical guiding principles, the guidelines require clinical trials cover should include drug of generic subjects, research types, research number, start date, completion date, the principal investigator (signature), research unit (leader), statistics, head of the signature and unit seal (stamp), drug registration applicant (stamp) and registration of the applicant contact person and contact number, date of report, the raw data saved location. At the same time, according to "about print and distribute chemical medicine pharmacy CTD data format standard (trial) electronic document style and finishing specification) filings and drug registration notice (food do note [2011] no. 98) drug safety in annex 2 requirements, clinical test report cover should bear the official seal of a clinical research base of effective seal shall be affixed with the text, and comply with the relevant state in chapter, has the force of law. 

 

How to handle the refunds or refunds of the new registration fees for chemical drugs? 

 

A: on the complementary approach. About chemicals new registered applicants should, in accordance with the classification of parties on matters relating to the charge standard circular no. 124 (2016), submit the supplementary cost application and relevant materials to the original department, issued by the original acceptance department administrative licensing item payment notice "(back)", the applicant a payment notice of the payment. 

 

About the refund method. About chemicals new registered applicants should, in accordance with the classification of parties on matters relating to the charge standard circular no. 124 (2016), submit the supplementary cost application and relevant materials to the original department, original acceptance department shall, in accordance with the "full" namely the cost of paying the full first, then submit corresponding fees refunded. 

 

4, is there any change in the prescription process in the process of being? 

 

Answer: BE in the process of test and reference formulation, active pharmaceutical ingredients, formulation, process changes, such as registration applicant by filing platform for the record, according to the facts, according to the production during the reporting data submitted in the past to change and for the record. 

 

How does the research and development organization (r&d) have completed the application for the registration of the first class products of the original classification before the release of the newly registered classification? 

 

Answer: "drug registration administration method" article 73 regulation, generic drug applicant should be a drug production enterprise. "The announcement of the reform of the classification of chemical and drug registrations" stipulates that the new category 3 and 4 categories of drugs shall be declared according to the procedure of generic drugs. Given prior to the release of part of the research and development institutions in the new registration classification has been basically completed original registration category 3 products research and development, for this kind of situation, still want to continue to declare if research and development institutions, can offer a written application to the ShengJu, confirmed by the ShengJu, as has been working in a new classification scheme before the release of related research work, and the need for clinical trials, according to new classification and generic procedures to accept the registration. 

 

Where the research and development institution is located within the pilot administrative region of the licensed holders of the listed drugs, the applicant shall make the declaration in accordance with the requirements of the holder.