China: Regulations on the Supervision and Administration of Drug Production for Export

 

China has published new Regulations on the Supervision and Administration of Drug Production for Export.

The purpose of the “Regulations on the Supervision and Administration of Drug Production for Export” is to regulate the drug manufacturing activities of Chinese manufacturers exporting drugs to other countries or regions, and to require the implementation of GMP. It mainly includes the following contents: general provisions, basic requirements, entrusted manufacturing for export, export drug archives, export certification documents (general requirements for export certification documents, Certificate of a Pharmaceutical product, Written confirmation for active substances exported to EU), supervision and management, and supplementary provisions.

In accordance with the Regulations:

Article 1 [Establishing Objectives] These regulations are formulated in order to strengthen the supervision and management of export pharmaceutical production and promote pharmaceutical export trade.

Article 2 [Scope of Application] The exported drugs referred to in these regulations refer to drugs (including pharmaceutical preparations, raw materials, and traditional Chinese medicine formula granules, the same below) produced and exported by enterprises in China that hold a “Drug Production License” (referred to as “exported drug manufacturers” in these regulations) and marketed in other countries (regions).

Article 3 [Related Responsibilities] Export pharmaceutical manufacturing enterprises bear the main responsibility for the quality and safety of exported pharmaceuticals. The State Food and Drug Administration is in charge of the supervision and management of the production of exported drugs nationwide, and provides guidance on the production supervision and management of exported drugs and the provision of services to the drug supervision and management departments of all provinces, autonomous regions, municipalities directly under the Central Government and the Xinjiang Production and Construction Corps (hereinafter referred to as the provincial drug supervision and management departments). Provincial drug regulatory authorities are responsible for the supervision and management of exported drugs by drug manufacturers within their respective administrative regions, and provide services for exported drugs upon application by export drug manufacturers.

Article 4 [Service Matters] The following tasks carried out by the provincial drug regulatory authorities are services provided for exported drugs: (1) Carry out drug production quality management practices (hereinafter referred to as drug GMP) compliance inspections on the production scope, workshops, production lines or varieties of exported drugs, and mark “export only” (or “export available”) in the “Drug Production License” dosage forms and production lines of exported drug manufacturers; (2) Upon application by the enterprise, based on the export drug production supervision and inspection, etc., issue export certification documents for exported drugs.

To find about more about these Regulations, please contact us directly.