Provisions for Post-approval Changes of Drugs (Interim)

Chapter I General Provisions

Article 1 These Provisions are formulated in accordance with the Drug Administration Law, the Vaccine Administration Law, the Provisions for Drug Registration (SAMR Order No. 27) and the Provisions for the Supervision and Administration of Drug Manufacture (SAMR Order No. 28) for the purpose of further regulating post-approval changes of drugs, strengthening the responsibilities of drug marketing authorization holder (hereinafter referred to as "MAH") for the management of post-approval changes of drugs, and strengthening the connection between drug registration and supervision and administration of production by drug regulatory departments.

Article 2 In the Provisions, the post-approval changes of drugs include the change of registration administrative items and the change of production supervision items.

The change of administrative items for registration includes the change of technical content and corresponding management information as specified in the drug registration approval documents and attachments thereof, and the specific change management requirements shall follow the Provisions for Drug Registration and relevant technical guidelines.

The change of supervision items for production includes the change of licensed items and the change of registered items specified in the Drug Manufacturing Certificate. The specific change management requirements shall follow the Provisions for Drug Registration, the Provisions for the Supervision and Administration of Drug Manufacture, and relevant provisions of the Good Manufacturing Practice for Drugs.

Article 3 MAHs shall proactively carry out post-approval study of drugs to realize the lifecycle management of drugs. It is encouraged that MAHs shall continuously improve and optimize the production process by using new production technologies, new methods, new equipment and new scientific and technological achievements, continuously improve drug quality and improve drug safety, efficacy and quality.

Post-approval changes shall not adversely affect the safety, efficacy and quality of drugs.

Article 4 MAHs are the main body of responsibility for the management of post-approval changes of drugs. MAHs shall establish a post-approval change control system in accordance with the laws and regulations on drug supervision, the Good Manufacturing Practice for Drugs and other relevant requirements; formulate and implement the principle for internal classification of changes, list of changes, working procedures and risk management requirements of MAH in accordance with the relevant technical guidelines of NMPA and ICH; and determine the change management category after sufficient study, evaluation and necessary verification in combination with product characteristics.

Article 5 The category of registration change management is divided into review and approval, filing and reporting according to the requirements of laws and regulations and the degree of risk that the change may have an impact on drug safety, efficacy and quality, and shall be implemented or reported after being approved and filed in accordance with relevant provisions in the Provisions for Drug Registration and the Provisions for the Supervision and Administration of Drug Manufacture.

Article 6 The NMPA shall be responsible for organizing to formulate the provisions for the post-approval change management of drugs, relevant technical guidelines and specific work requirements; be responsible for the review and approval of the post- approval change of administrative items for registration of drugs and the management of filing and reporting-type changes of the drugs manufactured overseas; and organize to implement the supervision and administration of post-approval changes of drugs in accordance with law.

Provincial drug regulatory departments shall be responsible for the permit and registration of the post-approval change of supervision items for production, and the filing and reporting of the post-approval change of administrative items for registration for the drugs of MAHs within their respective administrative regions in accordance with their responsibilities; and organize the supervision and administration of post-approval changes of drugs in accordance with law.