The 2020 Edition of the Pharmacopoeia of the People’s Republic of China (hereinafter referred to as 2020 Chinese Pharmacopoeia) has been issued by NMPA and NHC Announcement, and shall come into force as of December 30, 2020.
On July 3, NMPA hereby announced the following matters concerning the implementation of the 2020 Chinese Pharmacopoeia:
I. According to the provisions of the Drug Administration Law, drugs shall conform to the national drug standards. Chinese Pharmacopoeia constitutes an important part of the national drug standards, and is a legal technical standard that should be followed by relevant institutions in drug R & D, production (import), distribution, use, supervision and administration.
II. Chinese Pharmacopoeia is primarily composed of General Notices, Monographs and General Technical Requirements. From the date of implementation, all drugs
manufactured and marketed shall comply with the relevant technical requirements of the 2020 Chinese Pharmacopoeia.
III. As from the date of implementation, for drug varieties that have been recorded in former editions of pharmacopoeias and the standards promulgated by CFDA or Ministry of Health (MOH), but now are included in the 2020 Chinese Pharmacopoeia, the corresponding former editions of pharmacopoeias and the standards promulgated by CFDA or MOH shall be abolished simultaneously; where those varieties are not recorded in the 2020 Chinese Pharmacopoeia, the corresponding former editions of pharmacopoeias and the standards promulgated by CFDA or MOH shall still prevail, and meanwhile they shall comply with the relevant general technical requirements of the 2020 Chinese Pharmacopoeia; for drug varieties revoked or cancelled after post-marketing evaluation, the corresponding former editions of pharmacopoeias and the standards promulgated by CFDA or MOH shall be abolished.
For preparation specifications and TCM preparation methods that are not recorded in the Monographs of the 2020 Chinese Pharmacopoeia, their quality standards shall comply with the requirements for the same kind varieties specified in the 2020 Chinese Pharmacopoeia, and their specifications and preparation methods shall comply with the original approval documents.
IV. Where the test items recorded in drug registration standards outnumber or differ from those specified in the pharmacopoeia, or the quality indicators are stricter than the pharmacopoeia requirements, the corresponding items and indicators of the registration standard shall be implemented simultaneously while requirements of the pharmacopoeia have to be met.
Where the test items recorded in drug registration standards are fewer than those specified in the pharmacopoeia, or the quality indicators are lower than the pharmacopoeia requirements, the pharmacopoeia provisions shall prevail.
V. Due to the particularity of dissolution, release and other items in quality control, where the registration standards of generic drugs approved in accordance with the quality and efficacy consistency evaluation requirements are different from those specified in the Chinese Pharmacopoeia, NMPA shall elaborate such difference in the review & approval conclusion, the applicant shall submit a proposal to revise the corresponding national drug standard to the Chinese Pharmacopeia Commission within three months upon the approvalof corresponding registration application. Before the revision of the Chinese Pharmacopoeia is completed, the approved
drug registration standards shall be applied.
VI. To comply with the requirements of the 2020 Chinese Pharmacopoeia, where changes in drug formulation, production processes, and sources of raw materials and excipients are involved, drug marketing authorization holders and manufacturers shall follow the Provisions for Drug Registration, relevant technical guidance for changes in R & D techniques and the Good Manufacturing Practice for Drugs to conduct in-depth research and verification, obtain approval or complete filing according to relevant change category before implementation or report.
VII. For drugs whose generic names have been revised in the 2020 Chinese Pharmacopoeia, the names specified in the 2020 Chinese Pharmacopoeia shall prevail,
and their original names can be transitionally used as former names.
VIII. As from the date of implementation of the 2020 Chinese Pharmacopoeia, the corresponding application dossiers for drug registration application shall comply
with the relevant requirements of the 2020 Chinese Pharmacopoeia.
For registration applications that have been accepted with pending technical review before the date of implementation of the 2020 Chinese Pharmacopoeia, the
drug regulatory authority shall carry out corresponding review & approval according to the relevant requirements of the 2020 Chinese Pharmacopoeia as from the date
of implementation of the 2020 Chinese Pharmacopoeia, and applicants who need to supplement technical information shall complete the supplement at one submission.
Drugs approved for marketing according to the relevant requirements of previous pharmacopoeias after the date of issuance and before the date of implementation of the 2020 Chinese Pharmacopoeia shall comply with the relevant requirements of the 2020 Chinese Pharmacopoeia within 6 months after approval.
IX. Drug marketing authorization holders, manufacturers, and applicants for drug registration shall actively prepare for the implementation of the 2020 Chinese
Pharmacopoeia, and in a timely manner report the problems found in practice to the Chinese Pharmacopeia Commission, while continuously study and improve drug quality standards and persistently improve the level of drug quality control.
X. All provincial drug regulatory authorities shall cooperate in the publicity and implementation of the 2020 Chinese Pharmacopoeia, reinforce the supervision
and guidance in its implementation, in a timely manner collect and provide feedback on related issues and opinions.
XI. The Chinese Pharmacopeia Commission is responsible for uniformly organizing and coordinating the publicity, implementation, training and technical guidance of the 2020 Chinese Pharmacopoeia, opening up the 2020 Chinese Pharmacopoeia Implementation Column on its official website, and in a timely manner answering
questions reflected in implementation.
