China drug standards draft measures have recently been released by the National Medical Products Administration (NMPA).
The aim of the drug standards measures is to help standardize and strengthen the management of drug standards and ensure the safety, effectiveness and quality controllability of drugs in China.
This draft is the first time that the NMPA has developed an approach for the management of drug standards.
- Drugs shall comply with national drug standards. The Pharmacopoeia of the People’s Republic of China (hereinafter referred to as the “Chinese Pharmacopoeia”) and drug standards promulgated by the drug administration department under the State Council are national drug standards.
- Drug registration standards refer to the quality standards for specific drugs for specific applicants that have been reviewed by the Center for Drug Evaluation (CDE) and approved by the NMPA . The applicant shall implement the registration criteria.
- The NMPA encourages enterprises, social organizations, inspection institutions, scientific research institutions or individuals to participate in drug standards work and put forward reasonable opinions and suggestions.
- Article 18: Suggestions for Projects – Medical Products Administrations (MPA) at all levels, the National Pharmacopoeia Commission, the professional committees of the Pharmacopoeia Commission, drug marketing authorization holders (pharmaceutical manufacturers), operating enterprises, user units, inspection institutions, scientific research institutions, social groups and individual citizens may submit proposals for the formulation and revision of national drug standards.
- Encourage international exchanges and cooperation on drug standards and strengthen international coordination of drug standards.
Scope of Measures
- The planning, project establishment, formulation, revision, approval, promulgation, implementation, repeal, supervision and management of national drug standards shall apply to these Measures.
- The management of drug registration standards is in accordance with the relevant regulations on drug registration.
- The management of local drug standards is based on these Measures.
Pharmacopoeia of The People‘s Republic of China
- Chinese Pharmacopoeia Commission strengthens the top-level design of the drug standard system, grasps the overall standard research direction, and gives full play to the role of national drug standards in protecting and promoting public health.
- The Chinese Pharmacopoeia Commission is responsible for organizing the preparation, revision and compilation of “Pharmacopoeia of The People‘s Republic of China” and its accompanying standards, and the development and revision of other national pharmaceutical standards.
- The Chinese Pharmacopoeia shall include drugs commonly used in clinical practice, with precise efficacy, safe use, mature technology and controllable quality.
- The Chinese Pharmacopoeia is promulgated every 5 years. The Chinese Pharmacopoeia and its supplements are promulgated and implemented after approval by the drug administration department under the State Council.
- The supplement to the Chinese Pharmacopoeia has the same legal status as its corresponding current version of the Chinese Pharmacopoeia.
- With the exception of varieties that have been abolished for reasons of safety and efficacy, the drug standards contained in the original “Pharmacopoeia of The People‘s Republic of China” shall still be enforced, but they shall comply with the general technical requirements of the new edition.
Drug registration standards
- The CDE is responsible for the technical review of drug registration standards etc. The National Institutes for Food and Drug Control and the provincial drug testing institutes are responsible for drug registration testing and standard review.
- According to the needs of drug regulation and standard management, the Chinese Pharmacopoeia Commission organizes the conversion of drug registration standards into national drug standards in due course.
Local drug standards
- The drug standards issued by provincial MPAs are local drug standards.
- Local drug standards include local standards for medicinal materials, specifications for the preparation of Chinese herbal drinks and standards for preparations for medical institutions promulgated by provincial drug supervision and management departments that are not stipulated in national drug standards.
- Local drug standards will be abolished after they have been incorporated into national drug standards and promulgated.
Marketing Authorization Holder’s (MAH) responsibility
- Drug marketing authorization holders and pharmaceutical manufacturers shall implement the main responsibility of enterprises, promptly assess and improve drug standards, and improve drug quality.
- After the promulgation of national drug standards, drug marketing authorization holders and pharmaceutical manufacturers shall promptly assess the applicability of the national drug standards to the drugs they produce and their registration standards.
- Where the drug registration standards do not conform to the relevant requirements of the national drug standards or the inspection items are not applicable, the drug MAH and pharmaceutical manufacturer shall revise them in accordance with the provisions of the Measures for the Administration of Drug Registration; In accordance with the relevant provisions on the management of post-market changes of drugs, submit supplementary applications or filings to the CDE or the corresponding provincial MPA, and implement them after approval.
Supervision and Management
- The provisions set forth in pharmaceutical standards shall apply to drugs produced in accordance with the requirements of the Good Manufacturing Practice for Pharmaceuticals. Any pharmaceutical product produced in violation of the Good Manufacturing Practice or with an unapproved added substance cannot be considered to be in compliance with the requirements even if it meets the drug standard or the added substance or related impurities are not detected in accordance with the drug standard.
- “Drug standards” as used in these Measures refers to technical requirements formulated on the basis of the physical, chemical and biological characteristics of the drug itself in accordance with conditions such as source, prescription, preparation method, transportation, and storage, to test whether the quality of a drug meets the requirements for medicinal use, and to measure whether its quality is stable and uniform.
- National drug reference materials refer to substances used for physical, chemical and biological testing of drugs in national statutory drug standards, with certain characteristics or quantitative values, used for calibration equipment, evaluation of measurement methods, assignment or identification of test drugs.
- National drug reference materials are divided into five categories, including: standards, reference substances, contrast extracts, reference medicinal materials, and reference substances.
- The standards for medicinal excipients included in the Chinese Pharmacopoeia are the basic standards for their quality control, and the corresponding standards of the Chinese Pharmacopoeia must be implemented for pharmaceutical excipients that claim to comply with the Chinese Pharmacopoeia.
- The NMPA is responsible for the interpretation of these Measures.
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