Provisions for the Lot Release of Biological Products

 Chapter V Re-review

Article 34 If the lot release applicant objects to the Notice of Disapproval 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 35 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, 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 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.

(V)   The application for re-review is not submitted within the specified time;

(VI)  Other situations not suitable for re-review.

Article 36 If the re-review sustains the original decision, a Notice of Re-review Result for Lot Release of Biological Products shall be issued to the applicant, and the lot release applicant's further applications for re-review would no longer be accepted; if the re-review changes the original conclusions, the original Notice of Disapproval of Lot Release of Biological Products shall be withdrawn, and a Certificate for Lot Release of Biological Products shall be issued.

 Chapter VI Information Publication

Article 37 The NMPA shall establish a unified IMS, where it can publish information on the lot release institutions and relevant adjustments, decision on handling major issues, provide the lot release applicants with the searchable progress and conclusions of lot release, and disclose the products approved for lot release for public inquiries.

The NIFDC is responsible for daily operation and maintenance of the IMS.

Article 38 The lot release institution shall publicize lot release application procedures, the list of materials for lot release to be submitted, sample texts of application form, requirements for time limit and other information on its website or in the place where the application is accepted.

Article 39 Where the lot release is approved, the lot release institution shall disclose the product name, batch number, enterprise, validity period, lot release certificate number and other information within 7 days.

 Chapter VII Legal Liabilities

Article 40 If the drug regulatory departments, lot release institution, CFDI and their staff members constitute any of the following circumstances in the lot release work, sanctions shall be given to the directly responsible persons and  other directly responsible personnel by 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.

(V)   Where the on-site inspection is not conducted as prescribed.

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 138 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 123 of the Drug Administration Law.

If the lot release applicant provides false data, materials, or samples, or engages in deceptive behaviors in the application for lot release of vaccines, a penalty shall be imposed in accordance with the provisions of Article 81 of the Vaccine Administration Law.

If the Certificate for Lot Release of Biological Products is forged, a penalty shall be imposed in accordance with Article 122 of the Drug Administration Law.

Article 43 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 124 of the Drug Administration Law.

Chapter VIII Supplementary Provisions

Article 44 The time limit as prescribed in these Provisions shall be calculated by working days, excluding statutory holidays.

Article 45 The import of biological products which are subject to lot release administration shall also abide by laws and regulations on drug import. The Certificate for Lot Release of Biological Products may be used as a qualified certificate of the biological products in customs clearance that have been approved for lot release by the NMPA.

The exported vaccines shall meet the standards or contractual requirements of the targeted country (region) and apply for the lot release in accordance with such requirements.

Article 46 The NMPA shall be responsible for promulgating and updating the special seal of lot release institution, which is named as "Special Seal for National Lot Release Institution (X)". Where, X stands for the abbreviation of lot release institution.

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 Result 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.

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 Product shall be stamped with special seal for lot release of biological products in a unified manner.

Article 47 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 specified by the NMPA, with a format of "Lot release X (Import) Test XXXXXXXX", wherein the first X symbol represents the abbreviation of the administrative region of provinces, autonomous regions or municipalities 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 48 These Provisions shall go into effect as of March 1, 2021. The Provisions for the Lot Release of Biological Products by former CFDA Decree No. 39 promulgated on December 29, 2017 shall be superseded simultaneously.

[Related Links]

• Policy Interpretation of Provisions for the Lot Release of Biological Products 2020-12-21

• SAMR issued the Provisions for the Lot Release of Biological Products 2020-12-21

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.