Encourage enterprises and social third parties to participate in matters related to the formulation and revision of Chinese medicine standards

In order to further enhance the management capacity of Chinese medicine standards, establish the most rigorous standards, optimize the standard work mechanism, comprehensively build a new pattern of Chinese medicine standard work guided by the government, enterprise-oriented, social participation, open and integrated, and give full play to the important role of social forces in standard work, the announcement on the matters related to encouraging enterprises and social third parties to participate in the formulation and revision of Chinese medicine standards is as follows: First, the Chinese medicine standards referred to in this announcement refer to the Chinese medicine standards promulgated by the drug supervision and administration department under the State Council.
As well as the drug supervision and management departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, the standards for the preparation of Chinese medicinal materials, the specifications for the preparation of Chinese medicine tablets, and the quality standards
for Chinese medicine formula granules promulgated in accordance with the law.
For the registration standards of traditional Chinese medicines approved by the drug supervision and administration department under the State Council, the main responsibility for the improvement of them shall be performed
by the holder of the drug marketing authorization or the chinese medicine production enterprise.
Second, encourage and support enterprises and social third parties to increase investment in information, technology, talents and funds in the research and improvement of Chinese medicine standards, and put forward reasonable opinions and suggestions for the formulation and revision of Chinese medicine standards
。 Third, drug marketing authorization holders, Chinese medicine production enterprises, consortiums of enterprises and scientific research institutions, social groups or independent social third-party institutions can participate in the formulation and revision of Chinese medicine standards in the following ways: (1) According to the research and development, production and quality control of Chinese medicines, on the basis of continuously improving drug standards using scientific and advanced and economically reasonable technical methods, put forward suggestions or applications for the establishment of Chinese medicine standards that need to be formulated or revised to the State Pharmacopoeia Commission or the provincial drug supervision and management departments
。 (2) Formulate a revised work plan for Chinese medicine standards publicly released by the drug standards management department, and apply to undertake the research and drafting of standards or forward-looking research projects
.
(3) In the process of formulating and revising the standard, in accordance with the requirements of the corresponding technical specifications, research and provide Chinese medicine reference materials, test samples and testing data of
this related product.
(4) In the process of standard research, participate in the expanded verification or standard review carried out by the standard drafting organization, carry out production verification or standard review work in accordance with the published draft standards of traditional Chinese medicine, and provide relevant verification or review and inspection data, and put forward reasonable opinions or suggestions
on the problems found in the verification or review process.
(5) Attending or participating in relevant demonstration, review, consultation or discussion meetings on Chinese medicine standards in accordance with regulations; Participate in or support research, seminars and symposiums related to Chinese medicine standards, and actively contribute ideas
.
(6) Participate in or support the investigation and investigation of the implementation of Chinese medicine standards, collect and feedback on the implementation of Chinese medicine standards by enterprises or industries, and put forward suggestions and suggestions for improvement according to the implementation of standards
.
(7) Participate in or support the compilation and publication of supporting technical requirements, supporting series of books, works and other publications related to Chinese medicine standards
.
(8) Participate in and support the establishment and formulation of databases, information service platforms, and digital standards related to Chinese medicine standards; Provide information data and technical support for the construction, application and maintenance
of public information service platforms.
(9) Participate in or support the publicity, training and application promotion of Chinese medicine standards and testing techniques
.
(10) Participate in or support the formulation and revision of international botanical and medicinal (herbal) standards, technical cooperation exchanges, bilateral or multilateral coordination, and mutual recognition of standards
。 4.
Under normal circumstances, enterprises or social third parties shall submit project establishment suggestions or applications before the National Pharmacopoeia Commission or the provincial drug supervision and management departments issue standards to formulate revision work plans, and implement them in the following ways: (1) Project proposals shall include research objectives, research contents and preliminary work basis (including but not limited to important issues to be solved, background and reasons for project establishment, existing drug quality control safety risk monitoring and evaluation basis, etc.
), and the project proposals shall be sorted in order of priority
。 (2) The National Pharmacopoeia Commission or the provincial drug supervision and management departments shall promptly organize the demonstration of the proposals or applications for the establishment of Chinese medicine standards proposed by enterprises or social third parties, select the Chinese medicine standards that need to be formulated and revised into the standard formulation revision plan, publish the selection results, and organize the establishment of research; If necessary, participants in the demonstration
of proposals for revisions or applications for standard-setting revisions may be invited.
(3) Enterprises or social third parties participating in the research on the formulation and revision of Chinese medicine standards shall complete relevant research work in nationally recognized and qualified laboratories, and draft draft Chinese medicine standards and draft draft instructions
in accordance with the latest technical requirements such as the latest version of the National Drug Standards Work Manual, combined with the risks of drug quality control.
(4) Enterprises and social third parties shall be fully responsible
for the quality of the drafting standards and their technical content.
The draft chinese medicine standard submitted generally needs to be reviewed by one or more qualified inspection agencies recognized by the state to ensure the scientificity and reproducibility of
the standard drafting work.
V.
The research and provision of Chinese medicine reference standards shall comply with the relevant requirements
of the Chinese Pharmacopoeia and the National Drug Standards Working Manual.
The newly added Chinese medicine reference standards shall be filed with the China Institute of Food and Drug Control according to the filing
procedures.
6.
Chinese medicine production enterprises participating in the production and verification of the draft Chinese medicine standards shall carry out corresponding work in accordance with the impact of the draft standards on the safety, effectiveness, quality controllability and related technical requirements of the drugs; Pharmaceutical production enterprises and technicians participating in the production and verification of Traditional Chinese medicine standards shall have the corresponding qualifications and qualifications
.
7.
The State Pharmacopoeia Commission or the provincial drug supervision and management departments may adopt methods such as undertaking topics and supporting signatures, issuing honorary certificates, and awarding licensed drug standards scientific research bases in the issued drug standards (public draft or draft for comments) to encourage enterprises and social third parties to participate in or support the formulation and revision of
Chinese medicine standards 。 8.
The State Pharmacopoeia Commission and the provincial drug supervision and management departments shall, in accordance with the requirements and spirit of this Announcement, reform and optimize the relevant systems, procedures and technical requirements for the work of Chinese medicine standards, promptly disclose the progress and relevant information of the work of Chinese medicine standards, ensure the extensive and orderly participation of enterprises and social third parties in the formulation and revision of Chinese medicine standards, and promote the formulation of the most rigorous Chinese medicine standards
.
This is hereby announced
.
State Food and Drug Administration August 25, 2022 Talent Standards for Pharmaceutical and Pharmaceutical Enterprises