China News Service, March 30. According to the website information of the State Administration of Market Supervision, on March 30, the State Administration of Market Supervision announced the Measures for the Administration of Drug Registration by Order No. 27 and the Measures by the Order No. 28 of the Administration of Drug Production Supervision. The ministry regulations will come into effect on July 1, 2020. The two regulations highlight problem orientation, focus on addressing outstanding issues in drug registration and drug production supervision, and explicitly include clinically needed scarce drugs, children's drugs, drugs for rare diseases, drugs for major infectious diseases, urgently needed vaccines for disease prevention and control, and innovative vaccines. Speed up listing registration.
According to reports, the basic ideas followed in the drafting and revision of the two regulations: First, adhere to the "four strictest rules." Strict drug registration management and drug production supervision, strengthen the entire process of supervision, strictly prevent and control drug quality and safety risks, and resolutely maintain the bottom line of public safety.
The second is to deepen reform and innovation. Fully implement the management system for marketing license holders, encourage drug innovation, continuously optimize the drug registration review and approval system and drug production license system, and build a scientific and efficient review and approval process.
The third is to highlight problem orientation. Adhere to the people as the center, learn from the international regulatory practice experience, and combine the domestic regulatory reality, focus on solving the outstanding problems in drug registration and drug production supervision, and urgently need shortages of drugs, children's drugs, drugs for rare diseases, drugs for major infectious diseases, diseases Urgently needed vaccines and innovative vaccines are clearly included in the scope of accelerated registration. Clear requirements for ongoing compliance in pharmaceutical production.
The fourth is to strengthen the implementation of responsibilities. Strictly implement the main corporate responsibility and supervision responsibility, specify the obligations of drug development, registration, and production, and clarify the division of power and supervision and inspection requirements of the supervision department.
The main contents of the amendments to the two regulations include: First, the full implementation of the drug marketing authorization holder system. It is clear that the applicant is an enterprise or a drug development institution that can bear the corresponding responsibility, and requires the establishment of a drug quality assurance system, management of the entire life cycle of the drug, post-marketing research, and responsibility for the safety, effectiveness, and quality of the marketed drug.
The second is to optimize the review and approval workflow. Do a good job of linking all aspects of drug registration acceptance, review, inspection and inspection, change the original review, inspection and inspection from "series" to "parallel", establish breakthrough therapeutic drugs, conditional approval, priority review There are four accelerated channels for examination and approval, and the time limit for review is clear, which improves the efficiency of drug registration and the expectation of time limit for registration. According to the principles of risk management, implement the requirements of "decentralized management services" and implement classified management of changes.
The third is to implement full life cycle management requirements. Strengthen drug development, registration and post-market supervision. Increase the supervision of drug non-clinical research institutions, drug clinical trial institutions, and relevant requirements for drug safety credit files. Pay attention to the organic connection between registration and production license, implement the requirements for quality management of pharmaceutical production, and clarify the inspection procedures and follow-up measures for inspection results. Actively promote social co-governance, require public review conclusions and basis, and accept social supervision.
The fourth is to strengthen accountability. Refine penalties, severely crack down on illegal activities such as data fraud, and create a good environment to encourage innovation.
The State Administration of Market Supervision pointed out that as the core supporting regulations in the field of drug supervision, the revision of the two regulations will lay the foundation of the rule of law for strengthening drug quality and safety risk control, standardizing and strengthening drug supervision, ensuring drug safety, effectiveness, and quality controllability. In the next step, the State Food and Drug Administration will work hard to formulate supporting documents, ensure that all regulations are implemented, effectively improve the quality of drugs, and ensure that drugs are safe, effective, and accessible.