The Legislative Affairs Office of the State Council yesterday solicited opinions from the public on the "Measures for the Administration of Drug Standards" (hereinafter referred to as the "Measures"). It is reported that my country will compile a new "Pharmacopoeia of the People's Republic of China" (hereinafter referred to as "Chinese Pharmacopoeia") and other drug standards.
"Measures" proposed that drug standards include national drug standards, local drug standards and drug registration standards. Among them, the national drug standards include the "Chinese Pharmacopoeia" and other drug standards promulgated by the national drug supervision and administration department, and other drug standards and drug registration standards promulgated by the national drug supervision and administration department shall comply with the relevant general technical requirements of the "Chinese Pharmacopoeia.
"Measures" stipulate that the National Pharmacopoeia Committee is responsible for the formulation and revision of national drug standards, and unified regulations on relevant general technologies, including: general names and professional technical terms of drugs; technical requirements for the preparation of drug standards and content; Relevant technical requirements for pharmaceutical standard substances, etc.
In addition, the varieties included in the "Chinese Pharmacopoeia" should be drugs that are commonly used in clinical practice, have definite curative effect, are safe to use, have mature technology and have controllable quality. After the standard of "Chinese Pharmacopoeia" has been revised, the relevant contents shall be included in the new edition of "Chinese Pharmacopoeia" or its supplement. The Chinese Pharmacopoeia will be published every five years.
"Measures" also require that the formulation and revision of national drug standards should be carried out in accordance with drafting, review, and publicity. In case of major emergencies such as drug safety, the formulation or revision of national drug standards can be initiated as needed, and accelerated in accordance with relevant regulations. In addition, the national drug standards and the drug standards of the varieties contained in the "China Drug Catalogue Collection" should be disclosed to the public in a timely manner. From the date of implementation of the national drug standards, the production, operation, use, supervision and inspection of drugs shall be strictly implemented. Drugs that do not meet the national drug standards shall not be produced, sold or used. If there are special circumstances, a six-month transition period for the implementation of the standards may be given.
After the promulgation of the "Chinese Pharmacopoeia", the drug marketing authorization holder (drug manufacturer) shall promptly review the applicability of its drug registration standards. If the drug registration standards are inconsistent with the relevant requirements of the "Chinese Pharmacopoeia", the test items are less than or the quality indicators are lower than the "Chinese Pharmacopoeia", the drug marketing license holder (drug manufacturer) shall follow the "Drug Registration Management Measures" The provisions of the revised or implemented the "Chinese Pharmacopoeia". If the drug registration standards contain more than (including different from) the inspection items or the quality indicators are stricter than the "Chinese Pharmacopoeia", the drug marketing license holder (drug manufacturer) shall implement the corresponding items and indicators of the drug registration standards on the basis of the implementation of the "Chinese Pharmacopoeia. At the same time, the drug marketing license holder (drug manufacturer) shall, in accordance with the relevant provisions, mark the drug standards implemented on the drug instructions and labels.
In addition, the state also encourages the application of scientifically advanced and economically applicable technical methods to drug standards; encourages drug marketing license holders (drug manufacturers) to continuously improve drug standards; encourages enterprises and organizations or individuals to participate in drug standards Work, put forward reasonable opinions and suggestions; encourage international exchanges and cooperation in drug standards, and actively participate in the international coordination of drug standards.