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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: Chinese
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 Chinese Language
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