Provisions for the Lot Release of Biological Products

 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 NMPA.

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

Article 8 Drug testing institutions may, in accordance with the evaluation criteria and requirements, submit relevant working materials to the drug regulatory departments of provinces, autonomous regions or municipalities directly under the Central Government for undertaking lot release or expanding the product varieties subject to lot release. Where the drug regulatory authorities of  provinces, autonomous regions or municipalities directly under the Central Government deem upon the review that the lot release institutions meet the evaluation criteria, the application for evaluation of lot release institutions can be submitted to the NMPA. The NIFDC shall carry out competence evaluation and assessment on the drug testing institutions submitting the application. The NMPA authorizes the drug testing institutions to undertake lot release of the corresponding product varieties according to assessment results, or agrees to expand 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 NMPA in a timely manner.

Article 10 Under any of the following circumstances, the NMPA shall disqualify the institution of lot release:

(I)  Make major mistakes, causing serious consequences;

(II)  Issue a false testing report;

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

 Chapter III Application for Lot Release

Article 11 Before the initial application for lot release of the new biological product approved for marketing, the lot release applicant shall register and file in the Information Management System for Lot Release (hereinafter referred to as IMS). The following materials shall be submitted for registration:

(I)  Registration form for biological products subject to lot release;

(II)  Drug approval documents;

(III)  Supporting documents for legal production.

For relevant materials in line with the requirements, the NIFDC shall complete the registration confirmation of the product under application in the IMS within 10 days.

In case of any change in the registered information, the lot release applicant shall make a timely change in the IMS.

Article 12 For each variety subject to the application for lot release, the lot release applicant shall establish an independent template for the summary of the production and testing records of lot release, which shall be submitted to the NIFDC for verification and then be distributed after approval to the lot release institution and the applicant by the NIFDC. In case of a revision of the verified template for the summary of the production and testing records of lot release required, the lot release applicant shall submit an application to the NIFDC. The template shall not be changed until verified by the NIFDC.

Article 13 After completion of manufacturing and testing of biological products subject to lot release administration, the lot release applicant shall fill out the Application Form for Lot Release of Biological Products in the IMS, and apply to the lot release institution under jurisdiction for lot release in the place where the MAH applying for lot release is located or the import port is set.

Article 14 The lot release applicant shall propose a sampling application to the drug regulatory departments of provinces, autonomous regions or municipalities directly under the Central Government or the sampling institutions designated thereby by virtue of the Application Form for Lot Release of Biological Products; sampling personnel shall organize on-site sampling within 5 days, and seal the samples. The lot release applicant shall be responsible for delivering the sealed samples under the stipulated conditions to the lot release institution to handle registration for lot release, and shall submit lot release application dossiers at the same time.

The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for organizing the sampling of products subject to lot release for production or importation within their respective administrative regions, formulating sampling management procedures in accordance with the drug sampling regulations of the NMPA, determining relatively fixed sampling institutions and personnel to file at the lot release institutions, training the sampling institutions and personnel and conducting supervision and guidance for sampling work.

Article 15 When applying for lot release, the lot release applicant shall provide the following supporting documents, materials and samples:

(I)  Application Form for Lot Release of Biological Products;

(II)  Drug approval documents;

(III)  Supporting documents for legal production;

(IV)  Post-marketing change approval documents/filing documents;

(V)   Summary of batch production and testing records signed by the qualified person and affixed with the seal of the enterprise;

(VI)  For products with the same batch number which meet the testing requirements for lot release of relevant product variety in terms of quantity, materials on test-related intermediate products, standard substances, reagents, etc. shall be provided when necessary;

(VII)  Description of the changes in the key personnel including the production management person, quality management person, and qualified person;

(VIII)  Other materials relating to product quality.

When applying for the lot release of vaccines, the applicant shall also submit a list of records of process deviation, quality deviation, failures and accidents during the production as well as the corresponding measures taken, and the evaluation conclusion on the impact on the vaccine quality; in case of the vaccine quality may be affected, a deviation report shall also be submitted, including the deviation description, handling measures, conclusions of risk assessment, corrective and preventive measures taken or planned, etc. For major deviations that may affect the quality, the inspection and evaluation report of local drug regulatory departments of provinces, autonomous regions or municipalities directly under the Central Government shall be provided.

For an imported vaccine product or blood product, the certificate of origin of the country or region where the manufacturer is located and the lot release supporting documents issued by the local drug regulatory authority shall be provided at the same time. If an imported product is exempted from lot release in the country of origin, supporting documents for exemption of lot release shall be provided. A notarized Chinese translation shall be simultaneously provided for relevant supporting documents. If the relevant supporting documents are photocopies, they shall be affixed with the seal of the enterprise.

Summary of batch production and testing records of biological products refers to a document summarizing the testing results on all production processes and critical quality control links of a certain batch of biological products. Such document shall be reviewed and determined by the quality management department and the qualified person of the enterprise.

Article 16 After receiving the application dossiers and samples, the lot release institution shall immediately verify and properly preserve the same after registration and signature confirmation by the two parties. If the lot release applicant cannot sign for confirmation on the spot, it shall submit a written commitment in advance.

The lot release institution shall decide whether or not to accept the application within 5 days. If the lot release institution agrees to accept the application, it shall issue a notice of acceptance for lot release; if not, it shall return the application, issue the non-acceptance notice with the reason explained.

If the application dossiers are incomplete or nonconforming to the prescribed form, the lot release institution shall inform the lot release applicant of all contents to be supplemented and corrected and the time limit for supplementation in writing all at once within 5 days. Where the lot release institution fails to notify the applicant within the time limit, it shall be regarded as acceptance as of the date of receipt of application dossiers and samples.

Upon the receipt of the notice for supplementing and correcting dossiers, the lot release applicant shall submit the dossiers within 10 days. Failure to submit within the time limit without any justifiable reason shall be deemed as a waiver of the application and the decision of non-acceptance is not necessary to be made.

If application dossiers are found with the error that can be corrected on the spot, the lot release applicant is allowed to make rectification on the spot.

If the application is not accepted by the lot release institution, the applicant shall not re-apply for lot release to some other lot release institution.

Article 17 For biological products approved by the NMPA for urgent national disease prevention and control needs, the enterprise may apply to the lot release institution for concurrent lot release after completion of manufacturing.

Before the lot release institution makes any conclusion in lot release, the lot release applicant shall supplement the lot release application dossiers and submit them to the lot release institution.

Article 18 Vaccines, urgently needed to prevent and control outbreaks of infectious diseases or emergencies, may be exempted from lot release procedure after the approval of the NMPA.