Medical Policies Weekly
1. The General Office of the State Council issued the "Implementation Opinions on Comprehensively Strengthening the Capacity Building of Drug Supervision"
On May 10, the General Office of the State Council issued the "Implementation Opinions on Comprehensively Strengthening Drug Regulatory Capacity Building" ([2021] No. 16), and proposed 18 key tasks for drug regulatory capacity building: improve laws and regulations systems, improve standard management capabilities, improve technical review capabilities, optimize traditional Chinese medicine review mechanisms, improve inspection and law enforcement systems, improve inspection case handling mechanisms, strengthen coordination between regulatory agencies, improve inspection and testing capabilities, enhance biological product (vaccine) batch issuance capabilities, build national pharmacovigilance system, improve cosmetic risk monitoring capabilities, improve emergency management system, improve information traceability system, promote full life cycle digitize management, improve "Internet + drug supervision" application service level, implement scientific action plan for China's drug regulation, and improve the quality of supervision team and enhance the level of internationalization of supervision.
2. NMPA issued " Good Pharmacovigilance Practices”
On May 13, NMPA issued " Good Pharmacovigilance Practices”, the relevant matters are announced as follows:
1）The " Good Pharmacovigilance Practices” will be officially implemented on December 1, 2021.
2）Drug marketing authorization holders and drug registration applicants shall actively prepare for the implementation of the " Good Pharmacovigilance Practices”, establish and continuously improve the pharmacovigilance system as required, and standardize the development of pharmacovigilance activities.
3） The drug marketing authorization holder shall complete the information registration in the National Adverse Drug Reaction Monitoring System within 60 days from the date of this announcement.
4）The provincial drug regulatory authorities shall urge the drug marketing authorization holders in their respective administrative regions to actively prepare for the relevant publicity, implementation and interpretation, supervise and guide the drug marketing authorization to implement “Good Pharmacovigilance Practices” as required through strengthening routine inspections. and collects and feeds back related issues and opinions in time.
5）The National ADR Monitoring Center uniformly organizes and coordinates the publicity and implementation training and technical guidance of the " Good Pharmacovigilance Practices ", and opens up the " Good Pharmacovigilance Practices” column on the official website to answer related questions and opinions in time.
3. CDE Publicly solicits opinions on the "Guidelines for the Design of Once-a-Day Basic Insulin Biosimilar Clinical Research (Draft for Comment)”
In order to guide the clinical research and development of basic insulin biosimilars in China, CDE issued the " Guidelines for the Design of Once-a-Day Basic Insulin Biosimilar Clinical Research (Draft for Comment)” on May 12. One month from the date for suggestions. Based on the "Technical Guidelines for R&D and Evaluation of Biosimilar Drugs (Trial)", combined with the characteristics of once-a-day basal insulin and the recommendations of relevant foreign guidelines, this guideline further clarify the key issues in the clinical research design of biosimilars, including clinical research requirements, key points of clinical trial design (euglycemic clamp trial, clinical comparative study), extrapolation of indications, etc.
