Chinese Pharmacopoeia Latest Edition

[Patricia]

The2020 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:

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.

The Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA guidance document is intended to provide recommendations for the use of a comparability protocol (CP) to implement a chemistry, manufacturing, and controls (CMC) post-approval change of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs). It is acceptable to submit a CP in an original application or in a prior approval supplement (PAS) to an approved application to assess the effect of a proposed post-approval CMC change(s). Submission and approval of a CP may advance the implementation of CMC changes, and the FDA may allow the reporting of certain changes instead of requiring approval, which could result in distribution of a product with the change or facilitating a proactive approach to reinforcing the supply of the product sooner than if a CP were not used. According to this guidance, a CP should include the following content:

Different from provisions in 21CFR 314.70(e) and 601.12(e), not all proposed modification to an approved CP must be submitted as a PAS. This guidance provides for a less burdensome notification of certain types of modifications to an approved CP as provided for in 21 CFR 314.70(a)(3) and 601.12(a)(3), to make CPs more useful and flexible, and to facilitate keeping CPs current. Some examples are given in this guidance for which modification(s) must be submitted as a CBE-30 supplement, CBE-0 supplement, or annual report rather than a PAS. At the end of this guidance, the FDA provides recommendations for what should be done/considered when making a CMC change(s) in accordance with an approved CP and reporting the change(s) using the reporting category specified in the approved CP. Some questions and answers on CP(s) are provided in the Appendix.

The purpose of this document is to provide a general framework for virus testing, experiments for the assessment of viral clearance, and a recommended approach for the design of viral tests and viral clearance studies. The guidance states that manufacturers should avoid using human- and animal-derived raw materials (e.g., human serum, bovine serum, porcine trypsin) in their manufacturing processes when possible. In general, in order to determine the amount of endogenous virus particles that enter the purification process, quantification should be performed on three cell culture campaigns, lots or batches. This data should be submitted as part of the marketing application or registration package.

The Food and Drug Administration (FDA) is proposing to replace its current annual reporting requirement for investigational new drug applications (INDs) with a new requirement: the annual FDA development safety update report (FDA DSUR). The proposed rule would modify the format and content of the IND annual report to be generally consistent with those of the annual DSUR standards devised by the ICH. The proposed harmonization would result in reduced labor costs for certain sponsors who may no longer have to prepare different types of periodic safety reports for submission to certain other countries or regions wherea drug might be studied. Moreover, the FDA would receive safety data on investigational new drugs that is more comprehensive, which would enhance its ability to oversee the progress and safety of clinical investigations. Electronic or written comments on the proposed rule should be submitted by March 9, 2023.

The objective of this guideline is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The guideline recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents. Since there is no therapeutic benefit from residual solvents, all residual solvents should be removed to the extent possible to meet product specifications, good manufacturing practices, or other quality-based requirements.

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