Medical Policies Weekly
1."Chinese Medicine, Chemical Medicine and Biological Products Production Process, General Format for Quality Standard and Writing Guide"
According to the "Administrative Measures for Drug Registration" (Order No. 27 of the State Administration for Market Regulation), in order to standardize the submission of application materials, under the deployment of the NMPA, the Center for Drug Evaluation(CDE) has organized and formulated the "Chinese Medicine, Chemical Medicine and Biological Products Production Process, General Format for Quality Standard and Writing Guide" , which was reviewed and approved by the NMPA, and was released on July 19. It will come into force on the date of issuance.
Since the date of publication of the document, if the applicant’s drug registration application involves the approval of the production process and quality standards, it shall be written in accordance with the general format for the production process and quality standards; for the product under review involves the approval of the production process and quality standards, If the applicant has not contacted the drug review center or is in contact, it shall be approved in accordance with the general format, and if the contact has been completed, the review and approval can be continued in the original general format.
2. "Notice on the Timely Submission of Annual Reports on APIs, Pharmaceutical Excipients and Pharmaceutical Packaging Materials"
On July 22, CDE issued the "Notice on the Timely Submission of Annual Reports on APIs, Pharmaceutical Excipients and Pharmaceutical Packaging Materials", the main contents are as follows:
According to the "Announcement of the NMPA on Further Improving Drug-related Review, Approval and Supervision Work" (No. 56 of 2019), Article 15 of the announcement stipulates that "If the API marked as ‘A' undergoes technical changes, it should submit an application for changes to the relevant regulations of the current drug registration management and be implemented after approval. Other changes to APIs, pharmaceutical excipients and pharmaceutical packaging materials should be updated on the registration platform in time, and summarized in the annual report of the previous year submitted in the first quarter of each year."
Taking into account that some manufacturers of APIs, pharmaceutical excipients and pharmaceutical packaging materials did not submit their annual reports on time due to the epidemic, in order to encourage enterprises to resume work and production, upon request from the National Bureau, the submission time of annual reports of APIs, pharmaceutical excipients and pharmaceutical packaging materials is now open. Regarding the resumption of the time limit for the submission of the annual report, which will be informed separately.
3. " Technical Guidelines for Human Fibrinogen Clinical Trials (Draft for Soliciting Comments)"
In order to guide and standardize the clinical trials of human fibrinogen, CDE issued the "Technical Guidelines for Human Fibrinogen Clinical Trials (Draft for Soliciting Comment)" on July 22. It is now soliciting comments from the public and the time limit for comment is one month from the release date. The main content of the draft for comments includes 6 parts: preface, clinical trial procedures, clinical trials for adult and adolescent subjects, clinical trials for children subjects, clinical trials when pharmacy changes, and risk management plans, etc. It is applicable to the application for marketing authorization of human fibrinogen preparations, or to the development of clinical trials for pharmaceutical changes in marketed products.
4. Beijing, Tianjin, and Hebei province jointly issued the "Notice on Doing a Good Job in High-Quality Supervision of Drug Clinical Trial Institutions"
In order to implement the relevant work arrangements of General Office of the State Council of the People's Republic of China "Implementation Opinions on Comprehensively Strengthening the Construction of Drug Regulatory Capability", improve the standard system construction in the field of drug clinical trial supervision, and promote the coordinated development of Beijing-Tianjin-Hebei drug clinical trial supervision, Beijing, Tianjin, Hebei province jointly issued the "Notice on Doing a Good Job in the High-Quality Supervision of Drug Clinical Trial Institutions", which includes: unifying supervision and inspection standards, and gradually establishing a regulatory standard system for the coordinated development of drug clinical trial supervision in the three places; strengthening regulatory capacity building and continuously improve inspector team and the level of professional competence of employees; strengthen regional collaboration and explore new models of supervisory collaboration in the three places; improve quality management and strengthen the main responsibility of the agency. The appendix of the notice is the "Daily Supervision and Inspection Standards for Beijing-Tianjin-Hebei Drug Clinical Trial Institutions". The inspection standards are divided into three parts: organization and administration of drug clinical trials, ethics committee, and professional. It includes 30 inspection links and 133 inspection items. There are 18 key items and 115 general items, including inspections on the record conditions, institutional operation management, and project implementation.
5. "Technical Guidelines for Clinical Trials of Weight Control Drugs (Draft for Solicitating Comments)"
In order to encourage and promote the research and development of weight control drugs, CDE issued the "Technical Guidelines for Clinical Trials of Weight Control Drugs (Draft for Solicitating Comment)" on July 23, soliciting opinions from the public. The time limit for soliciting opinions is one month from the date of release. The main content of the draft for comments includes 6 parts: overview, overweight and obesity criteria and indications for drug treatment, clinical trial design points, safety, special populations, and reference documents, which are mainly applicable to weight control innovative drugs developed in China, and only for simple obesity (primary obesity), focusing on the considerations of confirmatory clinical trial design to make recommendations for the reference of enterprises and clinical research units.
6. "Guiding Principles for Writing Risk Analysis and Management Plan (Draft for Soliciting Comments)"
In order to encourage and support applicants to start writing the "Risk Analysis and Management Plan" document in the early stage of drug development, CDE issued the "Guiding Principles for Writing Risk Analysis and Management Plan" on July 23 for soliciting public opinions, the time limit is one month from the date of publication. The guiding principles are based on the requirements and recommendations of the guidelines of ICH "E2E: Pharmacovigilance Plan", comprehensively elaborate with the consideration and focus of risk evaluation in the review process of China's marketing authorization application. A drug "risk analysis and management plan" template is attached for industry reference, which consists of three parts: signature page, abstract and main text.
