The outline of the preparation of the Chinese Pharmacopoeia (2025 edition) has been released!

From: National Pharmacopoeia Editor: Crystal

On December 19, the Pharmacopoeia Commission released the outline
of the Chinese Pharmacopoeia (2025 edition).
The Outline points out that by 2025, the preparation of the new edition of the Chinese Pharmacopoeia will be fully completed
.

The standards of traditional Chinese medicines that meet the characteristics of traditional Chinese medicine have been further improved, the standards of chemicals, biological products, pharmaceutical excipients and pharmaceutical packaging materials have reached or basically reached the international advanced level, and the level of drug quality control and safety assurance has been significantly improved
.

Main tasks

By 2025, the compilation of the new edition of the Chinese Pharmacopoeia will be fully completed
.
The standards of traditional Chinese medicines that meet the characteristics of traditional Chinese medicine have been further improved, the standards of chemicals, biological products, pharmaceutical excipients and pharmaceutical packaging materials have reached or basically reached the international advanced level, and the level of drug quality control and safety assurance has been significantly improved
.

1.
One (Chinese medicine)

Improve the national drug standard system with the Chinese Pharmacopoeia as the core and in line with the characteristics of traditional Chinese medicine, adhere to the guidance of traditional Chinese medicine theory, the clinical efficacy of traditional Chinese medicine as the guide, and the scientific research of traditional Chinese medicine to formulate quality standards
for traditional Chinese medicine.
Continue to promote the international exchange of Chinese medicine standards and lead the formulation
of international standards.

(1) No less than 100 new standards for traditional Chinese medicines will be added, and no less than 500 standards for revised traditional Chinese medicines shall be revised
.

(2) Continue to improve the quality standard system that can reflect the traditional characteristics of Chinese medicine, the efficacy of Chinese medicine and the achievements of modern scientific research, improve the complete and interrelated quality standard system of Chinese medicinal materials, drinking tablets, Chinese medicine extracts and Chinese medicine formulas, and continue to improve the exclusivity, integrity and practicality of
Chinese medicine standards.

(3) Focus on the detection methods and limit standards for residues such as pesticides and plant growth regulators registered in medicinal materials and drinking tablets, and formulate corresponding limit standards by establishing guidelines for the formulation of limits that meet the characteristics of the use of traditional Chinese medicines.

Continue to improve the testing varieties and limit requirements
for banned pesticides.
Further carry out mycotoxin, heavy metal and harmful element residue screening, accumulate data, and improve the corresponding limit standards
.

(4) Focus on research and establish a detection method based on the undetectable aristolochic acid in proprietary Chinese medicines.

(5) Carry out basic research based on the consistency of the quality of wild products and cultivated products of Chinese medicinal materials, and continuously improve the quality standards
of cultivated products according to the research results.

(6) Continue to explore the establishment of green and environmentally friendly standards for Chinese medicines, and expand the application of mature analytical techniques in standards for Chinese medicines.

(7) Strengthen the research on the correlation between the qualitative and quantitative methods of index ingredients in proprietary Chinese medicines and their analysis methods of raw medicinal materials and drinking tablets, and use similar and similar methods to formulate their respective standards on the basis of reflecting the production process, so as to enhance their controllability and traceability.

(8) Strengthen research on the substitution of control extracts and reference materials of traditional Chinese medicines, and solve the problems
of qualitative and quantitative analysis of multiple components of traditional Chinese medicines, lack of reference materials and increased testing costs.

(9) Carry out research and transformation of biological evaluation and measurement methods based on the clinical efficacy of traditional Chinese medicine and basic scientific research of traditional Chinese medicine, and improve the quality standard system that can reflect the efficacy of traditional Chinese medicine, reflect the traditional characteristics of traditional Chinese medicine and modern scientific achievements by combining primit, morphology, microscopic, chemical composition and biological effects.

(10) Actively explore and improve the formation and management mechanism
of national standards for traditional Chinese medicine.
Encourage third parties in society to participate in the formulation and revision of national standards for traditional Chinese medicine
.
Explore the formation of an emergency revision mechanism
for national standards for traditional Chinese medicine.

Carry out medical and pharmaceutical evaluation of old varieties included in the pharmacopoeia, and withdraw from the pharmacopoeia in principle for varieties, varieties with unreasonable dosage forms or specifications, and varieties with serious safety problems that have not been used clinically for a long time.

2.
Part II (chemical drugs).

(1) About 100 new varieties will be added, and the collection of commonly used clinical drugs will continue to be
expanded.

(2) Make full use of advanced analysis technology, practice the scientific supervision concept of drug quality control, and ensure that quality standard items are comprehensive, methods are applicable, and limits are reasonable
.

(3) Make full use of the consistency evaluation of the quality and efficacy of generic drugs and the results of national drug sampling to promote the revision of national standards, and strengthen the transformation
of results into national standards.

(4) Revise and improve the procedures for formulating and revising national standards for chemical drugs and technical specifications (National Drug Standards Work Manual) that meet the new situation and new requirements, and improve the scientificity and applicability of
national standards.

(5) Establish an accurate and complete database
of national standards for chemical drugs.

3.
Part 3 (biological products)

Improve the standard system and scope of inclusion and further improve the scientificity, rigor and applicability of national standards; Improve the content of national standards for biological products and expand the scope of inclusion; Improve the standardization of detection methods and continue to promote the application of advanced physical and chemical analysis methods in the quality control of biological products; Accelerate the promotion of in vitro biological activity detection methods to replace animal in vivo detection methods
.

Complete at least 10 new general technical requirements for biological products (including general principles of biological products, general overview, and general principles and guidelines for testing methods).

Complete the establishment of the general theory of cell therapy products, and improve the general rules
of cell therapy and gene therapy products related detection methods.
Complete the establishment of relevant technical guidelines or general technical requirements for in vitro activity detection methods to replace in vivo animal tests, and strive to supplement or substitute in vitro methods in the determination of biological activity of individual breeds
.

10 new monographs have been added, including recombinant monoclonal antibodies (monoclonal antibodies, antibody conjugants, Fc fusion proteins), hormones and enzymes, as well as traditional vaccines and innovative epidemic vaccines newly launched in recent years, striving to achieve breakthroughs
in the monographs of cell therapy and gene therapy products.
80 monographs of varieties have been revised
.

4.
Four parts (general technical requirements)

(1) Further improve the general technical requirements system of the Chinese Pharmacopoeia, and strengthen its scientific, standardized, advanced, oriented and forward-looking
.
Further improve the general technical requirements of the Chinese Pharmacopoeia, strengthen the supervision of the whole life cycle of drugs, gradually extend drug quality control from the terminal to the production process and source control, move the risk control threshold forward, and comprehensively strengthen drug safety risk control
.

(2) Further deepen the linkage mechanism with major national science and technology projects, and transform the innovation achievements of major national science and technology projects into general technical requirements for the blank fields of domestic and international drug standards, and fully reflect the scientific and technological innovation achievements
of China's pharmaceutical industry.

(3) Strengthen the coordination of the general technical requirements of the Chinese Pharmacopoeia with domestic and international standards and the coordinated promotion
of variety standards.
Combined with the current situation of drug production and quality control in China, we continue to transform advanced and mature drug quality control concepts and analysis and testing technologies at home and abroad into general technical requirements
.

(4) Build a general technical requirement system for green drug standards that supports the goal of "carbon neutrality", and promote the application of
green analytical chemistry technology.
Research and formulate alternative methods for testing toxic and harmful reagents to reduce environmental pollution, personnel injury and experimental safety hazards
.

(5) Add and revise 80 general technical requirements
.

5.
Four parts (auxiliary materials and packaging materials)

(1) With the purpose of ensuring the safety of public medication, the goal of meeting regulatory needs, and the key meaning of promoting the development of the industry, benchmarking against international advanced concepts and standards, strengthening the top-level design of China's standard system for pharmaceutical excipients and pharmaceutical packaging materials, paying attention to the effective connection between the general technical requirements of pharmacopoeia pharmaceutical excipients and pharmaceutical packaging materials and variety standards, and paying attention to relevant regulatory regulations and technical documents Coordinated promotion
of industry norms.

(2) Improve the standard working mechanism for pharmaceutical excipients and pharmaceutical packaging materials, formulate supporting work procedures and technical specifications, and use a scientific and rigorous work system to ensure the formulation
of the "most rigorous standards".

(3) Further enhance the core position of the Chinese Pharmacopoeia as the national standard code for drugs, strengthen the symbiotic effect of "promoting technological innovation with standards and driving standard progress with technology", give full play to the technical advantages of production, learning, inspection, research, review and supervision, and drive the whole industry to pay attention to the continuous improvement of standards for pharmaceutical excipients and pharmaceutical packaging materials, and help China Improve the quality and efficacy of drugs to ensure the safety, effectiveness and accessibility
of drugs for the public.