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

 Chapter V Re-review

Article 33 If the lot release applicant holds objection to the Notice of Lot Release of Biological Products, it may propose an application for re-review to the original lot release institution or directly to the NIFDC within 7 days after receiving the Notice.

Article 34 The original lot release institution or the NIFDC shall decide whether or not to re-review within 20 days since the day when it receives the lot release applicant's application for re-review, and the content of re-review is only limited to the items in the original application or the original dossiers submitted by the applicant. If re-test is required as stipulated, the sample shall be the one retained by the original lot release institution, and the time limit shall conform to Article 22 hereof.

In case of any of the following circumstances, re-review shall not be approved:

(I) The nonconforming items are those that shall not be re-tested as specified by the food and drug regulatory departments such as sterility and pyrogen (bacterial endotoxin);

(II) The samples are obviously uneven;

(III) The shelf life of the samples cannot meet the need for test;

(IV) The lot release applicant makes a written commitment to give up the re-test.

Article 35 If the re-review sustains the original decision, a Notice of Re-review Result for Lot Release of Biological Products will be issued to the applicant, and the lot release applicant's further applications for re-review will no longer be accepted; if the re-review changes the original conclusions, the original Notice of Disapproval of Lot Release of Biological Products will be withdrawn, and a Certificate for Lot Release of Biological Products will be issued.

Chapter VI Information Publication

Article 36 The CFDA shall establish a unified Information Management System for Lot Release, release the determination and adjustment by the lot release institutions and provide the lot release applicants with the searchable progress and conclusions of lot release, and summarize and disclose the lot release conclusion of the products with the lot release completed and handling decision of major issues and other information.

The NIFDC is responsible for daily operation and maintenance of the Information Management System for Lot Release.

Article 37 The lot release institution shall publicize lot release application procedures, list of materials for lot release to be submitted, sample text of application form, charging standards and basis, requirements for time limit and other information on its website or in the place where the application is accepted.

Article 38 The lot release institution shall disclose the lot release conclusion and other information within 7 days after the decision on lot release for each batch of products made by the institution.

Chapter VII Legal Liabilities

Article 39 Any food and drug regulatory department, or lot release institution or its staff members that violate the provisions herein and in case of any of the circumstances below shall be ordered by its superior administrative authority or supervisory authority to make rectification. If the circumstances are serious, administrative sanctions shall be given to persons directly in charge and other directly responsible persons in accordance with law:

(I) Not accepting the lot release application that is in conformity with statutory requirements;

(II) Not publicizing on the institution's website or at the acceptance place the information that should be publicized according to law;

(III) Failing to fulfill the obligation to inform the administrative counterparts according to the provisions during the process of lot release;

(IV) Not informing the lot release applicant at once of all the content needed to be supplemented or corrected, where the application dossiers and samples submitted are incomplete or not conforming with the prescribed format;

(V)  Not stating the reasons for non-acceptance or disapproval of a lot release by law.

Article 40 Any food and drug regulatory department, or lot release institution or its staff members that constitutes any of the following circumstances in the lot release work shall be ordered by its superior administrative authority or supervisory authority to make rectification, and administrative sanctions shall be given to persons directly in charge and other directly responsible persons in accordance with law; if a crime is committed, criminal liabilities shall be investigated by law:

(I) Making the conclusions of approval for lot release for the application that does not meet the statutory requirements or acting beyond statutory authority to do so;

(II) Making the decision of disapproval of lot release for the application meeting the statutory requirements;

(III) Violating the procedure requirements to disclose relevant work information to the lot release applicant or the third party without permission during the process of lot release, causing serious consequences;

(IV)  Accepting or asking for the property or other interests of the lot release applicant during the process of lot release.

Article 41 If the lot release institution issues a false testing report when undertaking the lot release work, a penalty shall be imposed in accordance with Article 86 of the Drug Administration Law.

Article 42 If the lot release applicant provides false data or samples, or conceal major changes that will affect product quality and obtain the Certificate for Lot Release of Biological Products by fraud, a penalty shall be imposed in accordance with Article 82 of the Drug Administration Law.

If the Certificate for Lot Release of Biological Products is forged, a penalty shall be imposed in accordance with Article 81 of the Drug Administration Law.

Article 43 If it is found in on-site inspection that drug production fails to comply with the Good Manufacturing Practice for Drugs, a penalty shall be imposed in accordance with Article 78 of the Drug Administration Law.

Article 44 For the sales and use of the biological products that have not obtained the Certificate for Lot Release of Biological Products, a penalty shall be imposed in accordance with Article 73 of the Drug Administration Law.

Chapter VIII Supplementary Provisions

Article 45 The time limit for lot release as prescribed in these Provisions shall be calculated by working days, excluding statutory holidays.

Article 46 The import of biological products which are subject to lot release administration shall also abide by laws and regulations on drug import.

Article 47 Formats of the Application Form for Lot Release of Biological Products, the Registration Form for Lot Release of Biological Products, the Certificate for Lot Release of Biological Products, the Notice of Disapproval of Lot Release of Biological Products, the Notice of Re-review of Lot Release of Biological Products and the Notice of Re-review Result of Lot Release of Biological Products shall be developed in a unified manner and publicized by the NIFDC.

Article 48 The Certificate for Lot Release of Biological Products, the Notice of Disapproval of Lot Release of Biological Products and the Notice of Re-review Result of Lot Release of Biological Products shall be numbered by the lot release institution in sequence with a format of “Lot Release X (Import) Test XXXXXXXX”, wherein the first X symbol represents the abbreviation of the administrative region of the province, autonomous region or municipality directly under the Central Government in the place where the lot release institution is located or abbreviation of the institution; for imported biological products, “Import” shall be used; and in the last 8 X symbols, the former 4 X symbols represent the AD year, and the latter 4 X symbols represent the sequence number within the year.

Article 49 These Provisions shall go into effect as of February 1, 2018. Provisions for the Lot Release of Biological Products (CFDA Decree No. 11) promulgated on July 13, 2004 shall be superseded simultaneously.