Provisions for the Lot Release of Biological Products (CFDA Decree No.39)

Provisions for the Lot Release of Biological Products 

(CFDA Decree No.39)

                                                                                                                                                                                                                    Issued on December 29, 2017

CFDA Decree

No.39

Provisions for the Lot Release of Biological Products, deliberated and adopted at the executive meeting of China Food and Drug Administration on December 20, 2017, is hereby promulgated and shall go into effect as of February 1, 2018.

Minister: Bi Jingquan

December 29, 2017

Provisions for the Lot Release of Biological Products

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).

Article 2 For the purpose of these Provisions, lot release of biological products refers to the supervision and administration of China Food and Drug Administration (hereinafter referred to as the CFDA) for vaccines, blood products, in vitro diagnostic reagents for plasma source screening test which have obtained marketing authorization, and other biological products stipulated by the CFDA by designating drug control institutions to conduct dossier review, on-site inspection and sample testing for each batch of products before marketing or importation.

Products failing to pass lot release shall not be marketed or imported.

Article 3 Lot release applicants shall be domestic and overseas pharmaceutical enterprises holding drug approval documents. An overseas pharmaceutical enterprise shall authorize its office within the territory of China or an enterprise legal person in China as its agent to apply for the lot release.

The products subject to lot release shall be manufactured as per the process approved by the CFDA. Enterprises shall be responsible for the authenticity of the materials, records and data generated during the production and testing processes of the products subject to lot release. The materials for lot release shall be reviewed, signed and issued by the Qualified Person of the enterprise.

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 law, and ensure that the quality of the products under the application for lot release is reliable and the application dossiers, process records, testing data and the samples for lot release are authentic.

Article 4 The CFDA 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, and guides the implementation of lot release.

Food and drug regulatory departments of all provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for routine regulation of the applicants for lot release within their respective administrative regions, assisting the lot release institutions in conducting on-site inspection, organizing on-site sampling of products subject to lot release, disposal of products failing to pass lot release as well as investigation and handling of violations in the lot release process.

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

The CFDA entrusts the National Institutes for Food and Drug Control (hereinafter referred to as the "NIFDC") to organize the development of technical requirements and detailed rules of technical assessment for lot release, conduct capability evaluation and assessment of drug control institutions which are to undertake lot release or expand the scope of product varieties subject to lot release, and offer guidance, technical training and assessment and evaluation for other lot release institutions.

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

Article 5 The CFDA 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 drug registration requirements approved by the CFDA and also meet the requirements of the Pharmacopoeia of the People's Republic of China (hereinafter referred to as "the ChP").

Chapter II Determination of Lot Release Institutions

Article 7 The lot release institutions and the product varieties subject to lot release in their charge shall be determined by the CFDA.

The CFDA shall, in accordance with the needs of lot release work, in a timely manner announce the selection criteria and conditions for added lot release institutions and the product varieties added by the lot release institutions.

Article 8 The drug control institutions meeting the selection criteria and conditions in self-evaluation may submit an application to the food and drug regulatory departments of the provinces, autonomous regions or municipalities directly under the Central Government which shall report to the CFDA after preliminary review.

The NIFDC shall carry out capability evaluation and assessment on the drug control institution submitting the application. The CFDA designates the drug control institutions to undertake lot release of the corresponding product varieties according to assessment results, or expands the scope of product varieties subject to lot release in the charge of such institutions.

Article 9 The NIFDC shall, in accordance with the needs of lot release, make an evaluation on the lot release institutions and report the evaluation results to the CFDA in a timely manner.

Article 10 Under any of the following circumstances, the CFDA shall disqualify the lot release institution if it:

(I) makes major mistakes due to its own fault, causing serious consequences;

(II) issues a false testing report;

(III) fails to meet the criteria and conditions for the lot release institution after evaluation.