[The Chinese Pharmacopoeia 2010 English Edition Free Download 539

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Rapheal Charlton

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Jun 13, 2024, 6:45:20 AM6/13/24

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The 2020 Edition of the Pharmacopoeia ofthe People's Republic of China (hereinafterreferred to as 2020 Chinese Pharmacopoeia)has been issued by NMPA and NHCAnnouncement, and shall come into forceas of December 30, 2020. On July 3, NMPAhereby announced the following mattersconcerning the implementation of the 2020Chinese Pharmacopoeia:

The Chinese Pharmacopoeia 2010 English Edition Free Download 539

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I. According to the provisions of the DrugAdministration Law, drugs shall conformto the national drug standards. ChinesePharmacopoeia constitutes an importantpart of the national drug standards, and isa legal technical standard that should befollowed by relevant institutions in drug R&D, production (import), distribution, use,supervision and administration.

II. Chinese Pharmacopoeia is primarilycomposed of General Notices, Monographsand General Technical Requirements.From the date of implementation, all drugsmanufactured and marketed shall complywith the relevant technical requirements ofthe 2020 Chinese Pharmacopoeia.

III. As from the date of implementation,for drug varieties that have been recordedin former editions of pharmacopoeiasand the standards promulgated by CFDAor Ministry of Health (MOH) , butnow are included in the 2020 ChinesePharmacopoeia, the corresponding formereditions of pharmacopoeias and thestandards promulgated by CFDA or MOHshall be abolished simultaneously; wherethose varieties are not recorded in the 2020Chinese Pharmacopoeia, the correspondingformer editions of pharmacopoeias andthe standards promulgated by CFDA orMOH shall still prevail, and meanwhilethey shall comply with the relevant generaltechnical requirements of the 2020 ChinesePharmacopoeia; for drug varieties revokedor cancelled after post-marketing evaluation,the corresponding former editions ofpharmacopoeias and the standards promulgated by CFDA or MOH shall beabolished.

For preparation specifications and TCMpreparation methods that are not recordedin the Monographs of the 2020 ChinesePharmacopoeia, their quality standards shallcomply with the requirements for the samekind varieties specified in the 2020 ChinesePharmacopoeia, and their specifications andpreparation methods shall comply with theoriginal approval documents.

IV. Where the test items recorded in drugregistration standards outnumber or differfrom those specified in the pharmacopoeia,or the quality indicators are stricter thanthe pharmacopoeia requirements, thecorresponding items and indicators of theregistration standard shall be implementedsimultaneously while requirements of thepharmacopoeia have to be met.

Where the test items recorded in drugregistration standards are fewer thanthose specified in the pharmacopoeia,or the quality indicators are lower thanthe pharmacopoeia requirements, thepharmacopoeia provisions shall prevail.

V. Due to the particularity of dissolution,release and other items in quality control,where the registration standards of genericdrugs approved in accordance with thequality and efficacy consistency evaluationrequirements are different from thosespecified in the Chinese Pharmacopoeia,NMPA shall elaborate such difference inthe review & approval conclusion, theapplicant shall submit a proposal to revisethe corresponding national drug standardto the Chinese Pharmacopeia Commissionwithin three months upon the approvalof corresponding registration application.Before the revision of the ChinesePharmacopoeia is completed, the approveddrug registration standards shall be applied.

VI. To comply with the requirements of the2020 Chinese Pharmacopoeia, where changes in drug formulation, production processes,and sources of raw materials and excipientsare involved, drug marketing authorizationholders and manufacturers shall follow theProvisions for Drug Registration, relevanttechnical guidance for changes in R & Dtechniques and the Good ManufacturingPractice for Drugs to conduct in-depthresearch and verification, obtain approval orcomplete filing according to relevant changecategory before implementation or report.

VII. For drugs whose generic nameshave been revised in the 2020 ChinesePharmacopoeia, the names specified in the2020 Chinese Pharmacopoeia shall prevail,and their original names can be transitionallyused as former names.

VIII. As from the date of implementationof the 2020 Chinese Pharmacopoeia, thecorresponding application dossiers fordrug registration application shall complywith the relevant requirements of the 2020Chinese Pharmacopoeia.

For registration applications that havebeen accepted with pending technicalreview before the date of implementationof the 2020 Chinese Pharmacopoeia, thedrug regulatory authority shall carry outcorresponding review & approval accordingto the relevant requirements of the 2020Chinese Pharmacopoeia as from the dateof implementation of the 2020 ChinesePharmacopoeia, and applicants who needto supplement technical information shallcomplete the supplement at one submission.

Drugs approved for marketing accordingto the relevant requirements of previouspharmacopoeias after the date of issuanceand before the date of implementation of the2020 Chinese Pharmacopoeia shall complywith the relevant requirements of the 2020Chinese Pharmacopoeia within 6 monthsafter approval.

IX. Drug marketing authorization holders,manufacturers, and applicants for drugregistration shall actively prepare forthe implementation of the 2020 ChinesePharmacopoeia, and in a timely mannerreport the problems found in practice to theChinese Pharmacopeia Commission, whilecontinuously study and improve drug qualitystandards and persistently improve the levelof drug quality control.

X . All provincial drug regulatoryauthorities shall cooperate in the publicityand implementation of the 2020 ChinesePharmacopoeia, reinforce the supervisionand guidance in its implementation, in atimely manner collect and provide feedbackon related issues and opinions.

XI. The Chinese Pharmacopeia Commissionis responsible for uniformly organizing andcoordinating the publicity, implementation,training and technical guidance of the2020 Chinese Pharmacopoeia, openingup the 2020 Chinese PharmacopoeiaImplementation Column on its officialwebsite, and in a timely manner answeringquestions reflected in implementation.

Traditional Chinese medicine (TCM) are becoming more and more popular all over the world. However, quality issues of TCM may lead to medical incidents in practice and therefore quality control is essential to TCM. In this review, the state of TCM in European Pharmacopoeia are compared with that in Chinese Pharmacopoeia, and herbal drugs that are not considered as TCM and not elaborated by TCM working party at European Directorate for the Quality of Medicines & Health Care (EDQM) but present in both European Pharmacopoeia and Chinese Pharmacopoeias are also discussed. Different aspects in quality control of TCM including origins, identification, tests and assays, as well as sample preparation, marker selection and TCM processing are covered to address the importance of establishing comprehensive quality standard of TCM. Furthermore, advanced analytical techniques for quality control and standard establishment of TCM are also reviewed.

Therefore the objectives of this review is to summarize and discuss the differences between the TCM monographs in EP 10th edition (data updated to supplement 10.2, published in January, 2020) and ChP 2020 edition to emphasize the state of TCM monographs in the EP. Note that TCM in this review refer to the 73 herbal drugs considered as TCM in both pharmacopoeias in order to avoid confusions, other examples out of the 73 TCM are given as herbal drugs in general. Furthermore, some advanced analytical techniques for quality standard of herbal drugs and TCM are also discussed to show the progress of TCM quality control.

In addition, Latin synonyms in pharmacopoeias could be an issue for identification of botanical origins of TCM. An analysis showed that at least 16.13% Latin names of TCM in ChP (2010 edition) were not in accordance with Flora of China and the reasons of the issue may include: repeat naming of the same species; synonyms of the families; new definitions of species and families; as well as traditional use of old Latin names [16]. Among the 73 TCM reviewed, 24 entries have Latin synonyms stated in EP, and some other TCM without annotation may also have Latin synonyms. For example, botanical origins of Sinomenii Caulis in ChP include Sinomenium acutum (Thunb.) Rehd. et Wils. or Sinomenium acutum (Thunb.) Rehd. et Wils. var. cinereum Rehd. et Wils. But in fact, the latter is synonym of the former, and the former is the botanical origin stated in EP, thus the botanical origin of Sinomenii Caulis in both pharmacopoeias is actually the same. Therefore, when determining the botanical origins of TCM, Latin synonyms is still an issue that should be addressed.

In the application of TCM, herbs could be applied either as in whole plant, or as in different parts of the plant such as aerial parts, underground parts, root, rhizome, stem, bark, leaf or flower. Furthermore, active constituents and harmful constituents may be varied in different parts of an herb. Therefore, it is very important to specify the medicinal parts in quality standard of TCM. By comparing the stated medicinal parts of TCM between the two pharmacopoeias, most are the same except few such as Ephedrae Herba and Sanguisorbae Radix (Table 1). But the differences in these TCM are small, such as underground parts instead of root, thus little or no influence would be generated under the circumstances.

The above examples imply that it is important to specify the botanical source and the medicinal part of a TCM, because substantial differences may occur in the components and pharmacological effects when the wrong plant or medicinal parts are applied. However, the origin of herbal drugs and TCM stated in pharmacopoeias may be more or less influenced by the species available and the application habit in the region. Therefore, extensive research are required to show that if those differences could be compatible with each other and whether substitution is possible for one to another.