China: Implementation of Administrative Measures of Drug Standards (1 January 2024)

Starting from 1 January 2024, the National Medical Products Administration (NMPA) will enforce the implementation of Administrative Measures for Drug Standards, which refers to the technical requirements made from the drug’s attributes (origin, formulation, manufacturing processes, drug storage). The standards will be applied for quality evaluations in order to ensure the quality is in line with the medical use requirements. The enforcement includes all China drug standards categories:

• National Drug Standards: Directly issued by NMPA

• Drug Registration Standards: Proposed by drug registration applicants and verified by the Centre for Drug Evaluation (CDE). The Marketing Authorization Holder (MAH) will receive finalized drug standards and supplemental application certificate approval once NMPA approves the applications.

• Traditional Chinese Medicines provincial-level Standards (TCMs): Granted for TCM ingredients and granules that are excluded from the national drug standards.

The Marketing Authorization Holders (MAHs) are heavily involved in formulating drug standards, contributing to the drafting of drug registration standards, submitting draft standards to the CDE for review, and obtaining the finalized standards after NMPA approval.

Additionally, the drafting process must be developed scientifically by conducting a comparison study and analyzing the approaches and constraints of the drug registration standards. In order to modify the registration standards, MAHs must also abide by the post-marketing adjustments regulations.

While submitting the supplemental application that calls for modifications to the drug registration standards, MAHs must take into account the applicability and implementation requirements of the national drug standards and the drug registration standards. MAHs have to explain the implementation state of the drug registration standards to the CDE or TCM products administration during the submission of the drug registration renewal application.

Source: National Medical Products Administration (NMPA)