What Marketing Authorization Holders (MAHs) Should Do About China Drug Standards

The Administrative Measures for Drug Standards, issued by China National Medical Products Administration (NMPA) issued in 2023, took effect on the first day of 2024. 

Drug standards refer to technical requirements made according to the drug’s physiochemical and biological attributes, based on its source, formulation, manufacturing process as well as conditions for transport, storage, etc., to evaluate whether the drug’s quality meets the medical use requirements before expiry, and whether its quality is uniform and stable. 

China’s drug standards are divided into three categories:

1. Applicant/MAH as the Drafter of Drug Registration Standards

Drug applicant companies can participate in the formulation of national drug standards and provincial-level TCM standards. For example, they can advocate the revision of those standards and give advice/comments on the draft standards. In particular, pharmaceutical companies can play a major role in drafting drug registration standards.

The applicants shall hand in the draft standards to CDE, along with marketing authorization applications or supplemental applications that involve changes to the original registration standards. The draft standards will be verified and finalized by CDE, with re-verification and sample testing completed by drug testing agencies. The finalized standards will be sent to the applicants/MAHs after NMPA approves the marketing authorization applications or supplemental applications.

2. Requirements for Making Drug Registration Standards

Applicants/MAHs should formulate drug registration standards scientifically and reasonably. The standards should be used to effectively control product quality, with full consideration of product characteristics, new technologies & methods brought by scientific & technological progress, and international technical requirements. 

Requirements in the drug registration standards should be no lower than those in the Chinese Pharmacopoeia. 

If deeming that the Chinese Pharmacopoeia does not apply to the testing or indexes of the proposed drug, the applicant should provide sufficient data to support the thinking.

3. Changes to Drug Registration Standards

To change the registration standards, MAHs shall comply with post-marketing change rules (e.g., Provisions for Post-approval Changes of Drugs (Interim)), conduct sufficient researches & evaluation, as well as necessary validation. Afterwards, MAHs shall submit a supplemental application, file for the change, or document the change in the annual report.

Read about “Categories of Post-approval Changes” and required dossiers for changes.

4. Comparative Study

Chinese Pharmacopoeia is renewed every five years. When Chinese Pharmacopoeia Commission issues a new edition, MAHs that carry out the drug registration standards should conduct comparative study in time, for evaluating whether the items, methods, and limits in the drug registration standards, to comply with the new edition’s standards.

If the study manifests the necessity to change the drug registration standards, the MAHs should follow the relevant rules mentioned in 3. Changes to Drug Registration Standards of this article.

5. Requirements Related to Applications and Certificates

When submitting certain applications or receiving certain certificates, MAHs should note the following points:

6. Abolishment of Drug Registration Standards

If a drug registration certificate is cancelled, the corresponding registration standards become null and void.

Ask BaiPharm if you’d like to know more about China drug standards.