In this post you can download Chinese Pharmacopoeia 2020 in English pdf free download (CP-20) by click on dowload button given below in English Language.
Chinese Pharmacopoeia 2020 pdf free download
The 2020 edition of the Pharmacopoeia of the People's Republic of China (referred to as the "Chinese Pharmacopoeia") is the eleventh edition of the Pharmacopoeia. According to the Eleventh Pharmacopoeia Committee The Pharmacopoeia Compilation Outline requirements reviewed and approved by the Legislative Assembly and the General Committee Meeting, guided by the establishment of "the most stringent standards" to improve drug quality, With the purpose of ensuring drug safety and serving drug supervision, under the leadership of the State Drug Administration, relevant drug testing institutions and scientific research institutions With the strong support of and the active participation of domestic and foreign pharmaceutical manufacturers and associations, the National Pharmacopoeia Committee organized and completed the "Chinese Pharmacopoeia" 2020 Various tasks for the compilation of the annual edition.
On April 9, 2020, the Executive Committee of the Eleventh Pharmacopoeia Committee reviewed and approved the 2020 edition of "Chinese Pharmacopoeia". It will come into force after being reviewed and approved by the State Drug Administration in conjunction with the National Health Commission.
This edition of the Pharmacopoeia contains 5911 species, 319 species were added, 3177 species were revised, 10 species were no longer included, and 6 species were reduced due to the merger of varieties. one part There are 2,711 kinds of traditional Chinese medicines, including 117 new ones and 452 revised ones. There are 2712 kinds of chemical medicines in the second volume, including 117 new ones and 2387 revisions.
kind. The three volumes of biological products contain 153 species, of which 20 are newly added and 126 are revised; 2 new general principles and 4 general introductions are added. Four collections There are 361 general technical requirements, including 38 general rules for preparations (35 revised), 281 general rules for testing methods and others (35 new, revised 51 were ordered), 42 guidelines (12 newly added, 12 revised); 335 kinds of pharmaceutical excipients were recorded, of which 65 were newly added, revised 212 species.
Language: English
Main features of this edition of Pharmacopoeia:
Steadily promote the collection of pharmacopoeia varieties. The variety collection is oriented to clinical application, and continuously meets the needs of the national essential drug list and basic medical insurance.
The demand for varieties included in the Drug Catalogue, further guaranteeing the quality of clinical medication. Timely record the standards of newly marketed drugs, fully reflecting my country's pharmaceutical innovation research and development post the latest results.
Improve the national drug standard system. Further reflect the full life cycle management of drugs by improving the Pharmacopoeia General Rules and related general technical requirements idea. Combining the characteristics of various drugs such as traditional Chinese medicine, chemical drugs, and biological products, the quality control gate is moved forward, and the source and whole process of drug production are strengthened quality management. Gradually form a standard system for raw materials, pharmaceutical excipients and pharmaceutical packaging materials with the goal of ensuring the quality of preparations.
Provide technical support for batch system reform.
Expand the application of mature analysis techniques. Keep up with the international frontier, continuously expand the promotion and application of mature detection technology in drug quality control, The sensitivity, specificity, applicability and reliability of the test method have been significantly improved, and the quality control methods of drugs have been further strengthened. new polymerase Chain reaction (PCR) method, DNA sequencing technology guidelines, etc., to promote the application of molecular biology detection technology in Chinese herbal pieces and animal tissue source materials.
materials, starting materials of biological products, traceability and identification of microbial contamination; newly added X-ray fluorescence spectrometry, monoclonal antibody product characteristic analysis method The method, the use of transgenic detection technology for the activity detection of recombinant products, etc.
Improve drug safety and effective control requirements. Focus on research on detection methods and limits related to safety and effectiveness, and further improve High drug quality although controllable. In terms of safety, the protection against heavy metals and harmful elements in medicinal herb pieces, prohibited pesticide residues, and fungi have been further strengthened.
Control of toxins and endogenous toxic components. Strengthen the qualitative and quantitative research on chemical drug impurities, and control the known impurities and unknown impurities separately; For high-risk preparations such as injections, quality control items related to safety have been added, such as the determination of osmolality. Enhanced biologics virus Safety control, established the control of vaccine aluminum hydroxide adjuvant and related protein of recombinant technology products. In terms of effectiveness, established and improved Specific identification methods for Chinese herbal medicines and decoction pieces, and some products have established content control of ingredients related to clinical efficacy. Combining generic quality with The registration standards for varieties of efficacy consistency evaluation have revised the dissolution items of the relevant standards of the Pharmacopoeia; quality control requirements. The general introduction to human PEGylated recombinant protein and polypeptide products, wax allergen products and human gene therapy products has been updated, Recombinant therapeutic biological products have been updated with relevant protein detection and limit requirements, etc.
Improve the standard level of Fupu. Focus on increasing the collection of standards for pharmaceutical excipients commonly used in preparation production, and improve the safety and functionality of pharmaceutical excipients Indicators, gradually improve the national standard system for pharmaceutical excipients, promote the quality improvement of pharmaceutical excipients, and further ensure the best quality of preparations.
Strengthen the coordination of international standards. Strengthen the comparative study with foreign pharmacopoeias, pay attention to the reference and transformation of international mature technical standards, and continuously promote the Harmonization of national pharmacopoeia standards. With reference to the relevant guidelines of the International Council for Harmonization of Technical Requirements for Registration of Drugs for Human Use (OCH), the guidelines for the control of genotoxic impurities were added, and the guidelines for stability testing of raw materials and preparations, analytical method verification, and drug impurity analysis were revised, and the dissolution rate was added.
Determination of flow cell method, bulk density and tap density determination method, revision of residual solvent determination method, etc., and gradually promote ICH related guidelines in "Chinese Medicine The implementation of the transformation of the Code.
Strengthen the guiding role of Pharmacopoeia. Keeping up with the development trend of international drug standards, taking into account the actual situation of drug production in my country, in the concept of drug supervision, Quality control requirements, testing technology application, process control, product development guidance and other aspects are continuously strengthened. In terms of testing items and limit setting On the one hand, it not only considers the bottom line of ensuring drug safety, but also pays full attention to the accessibility of clinical drugs, and further strengthens the guidance of Pharmacopoeia on drug quality control effect.
Improve the pharmacopoeia working mechanism. Always adhere to the principles of openness, fairness and fairness, and constantly improve the formation mechanism of drug standards. organize drug testing Inspection institutions, scientific research institutions and other units continue to carry out research on standard topics, and encourage more pharmaceutical manufacturers, industry organizations and all sectors of society to actively participate The formulation and revision of national drug standards actively researches and responds to industry feedback and suggestions.
Strictly implement the working rules of the professional committee, strengthen the committee management to prevent conflicts of interest. Improve the quality assurance system, optimize the work process, strengthen risk prevention and control, strengthen the whole process management, and further guarantee Pharmacopoeia compilation quality is the best.
The compilation of this edition of the Pharmacopoeia adheres to the principles of scientificity, advancement, practicability and standardization, and continuously strengthens the role of "Chinese Pharmacopoeia" in national drug standards.
The core position in the industry, the standard system is more complete, the standard formulation is more standardized, the standard content is more rigorous, and it is more coordinated with international standards.
The overall level of the standard has been further improved, fully reflecting the current situation of my country's pharmaceutical development and testing technology application, and is the most important in improving the quality of my country's medicines.
It will play an important role in ensuring the safety of public medication, promoting the healthy development of the pharmaceutical industry, and enhancing the international influence of the Chinese Pharmacopoeia.
Chinese Pharmacopoeia 2020 in English Language
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