Provisions for the Lot Release of Biological Products

SAMR Decree

No.33

Provisions for the Lot Release of Biological Products, deliberated and adopted at the 11th executive meeting in 2020 of State Administration for Market Regulation on November 19, 2020, is hereby promulgated and shall go into effect as of March 1, 2021.

Minister Zhang Gong

December 11, 2020

Provisions for the Lot Release of Biological Products

(Decree No. 33 issued by State Administration for Market Regulation on December 11, 2020)

Chapter I General Provisions

Article 1 In order to strengthen the supervision and administration of biological products, regulate the lot release of biological products, and ensure the safety and efficacy of biological products, these Provisions are hereby formulated in accordance with relevant regulations in the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law) and Vaccine Administration Law of the People's Republic of China (hereinafter referred to as the Vaccine Administration Law).

Article 2 Lot release of biological products in these Provisions refers to the process of reviewing and testing for vaccine products, blood products, in vitro diagnostic reagents for blood screening obtained marketing authorization and other biological products specified by National Medical Products Administration (NMPA), prior to marketing or importation, and issuing the lot release certification by designated lot release institutions.

Products failing to pass lot release shall not be marketed or imported. Products exempted from lot release as approved by the NMPA in accordance with the law shall be excluded.

Article 3 Lot release applicants shall be domestic and overseas drug marketing authorization holders (MAHs) holding drug approval documents. Overseas drug MAHs shall designate an enterprise legal person within the territory of the People's Republic of China to handle the lot release.

Lot release products shall be manufactured in accordance with the approved process and shall conform to the national drug standards and drug registration standards. The entire production process shall comply with the Good Manufacture Practice for Pharmaceutical Products. MAHs shall establish a complete production quality management system and continuously strengthen the management of deviation. MAHs shall be responsible for the authenticity of the materials, records and data generated during the production, testing and relevant processes of the lot release products. Lot release materials shall be reviewed, signed and issued by the qualified person of the MAHs.

Before the marketing of each batch of products or when each batch of products are imported, the lot release applicant shall voluntarily submit the application for lot release, fulfill the statutory obligations in the lot release activities in accordance with the law, and ensure that the quality of the products under the application for lot release is reliable, and that the application dossiers and the samples for lot release are authentic.

Article 4 The NMPA shall be in charge of lot release of biological products nationwide, specifies the scope of product varieties subject to lot release, designates lot release institutions, clarifies the requirements for lot release and guides the implementation of lot release.

The drug regulatory departments of provinces, autonomous regions or municipalities directly under the Central Government shall be responsible for the supervision and administration of lot release applicants within their own administrative regions and for organizing on-site inspection of products subject to lot release within their own administrative regions; shall assist lot release institutions to carry out on-site inspection, organize on-site sampling of products for lot release and disposal of non-conforming products in lot release, investigate and handle major quality risks and illegal behaviors identified during the process of lot release and in a timely manner inform lot release institutions of the investigation and disposal results; shall investigate the major deviations that may affect product quality in the production processes of enterprises and issue an inspection and evaluation report; and shall be responsible for the daily management of lot release institutions within their own administrative regions.

The lot release institutions designated by the NMPA shall be responsible for the acceptance, dossier review, and sample testing and the decision-making on lot release in accordance with the law.

The National Institutes for Food and Drug Control (hereinafter referred to as NIFDC) organizes the development of technical requirements and detailed rules of technical assessment for lot release, conducts competence evaluation and assessment of drug testing institutions which are to undertake lot release or expand the scope of product varieties subject to lot release, and offers guidance, technical training, assessment and evaluation for other lot release institutions; organizes and coordinates the lot release institutions to implement lot release.

Center for Food and Drug Inspection of NMPA (hereinafter referred to as CFDI) shall be responsible for overseas on-site inspection during lot release.

Article 5 The NMPA shall establish a risk-based regulation system for the products subject to lot release. If necessary, on-site inspection may be carried out to validate the authenticity and reliability of the application dossiers for lot release.

Article 6 The review and test for the lot release of biological products shall be conducted in accordance with the national drug standards and drug registration standards.