I. Background for Development

In order to implement the spirit of "Supporting the Export Trade of Drugs and Medical Devices" outlined in the Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of the Regulation of Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry (GBF [2024] No. 53), the National Medical Products Administration (NMPA) has formulated the Administrative Provisions on Inspection and Export Certificate for Pharmaceutical Products Exported by Pharmaceutical Manufacturers, (hereinafter referred to as the "Provisions"). These Provisions stipulate that inspections of exported pharmaceutical products will be conducted in accordance with Good Manufacturing Practice (GMP), and export certificates and other relevant services will be provided for Chinese pharmaceutical products to support and encourage the entry of more Chinese pharmaceutical products into the international market.

II. Scope of Application

The term "exported pharmaceutical product" in the Provisions refers to the product manufactured by manufacturers within the territory of China that hold a Drug Manufacturing License, exported to other countries (regions), and regulated as pharmaceutical products and marketed in the importing countries (regions), including the products that have been marketed and those not yet marketed within the territory of China. The scope of "marketing" in the Provisions includes the products for which a marketing application is proposed, in addition to the products that have been marketed in the importing countries (regions). In terms of product category, it includes pharmaceutical preparations, active substances, and traditional Chinese medicine dispensing granules. Additionally, an export certificate can be applied for intermediate products of pharmaceutical preparations with reference to the Provisions.

The Provisions require that the production activities of exported pharmaceutical products shall be conducted in strict compliance with the GMP in the production workshops and production lines specified in the Drug Manufacturing License. Where the manufacturers of exported pharmaceutical products produce chemical products and other non-pharmaceutical products at the same time, these products shall not be exported under the name of pharmaceutical products, even if they possess pharmaceutical activity. Furthermore, the documents, such as the Drug Manufacturing License issued by the drug regulatory authorities, shall not be used in the trade of such products.

III. Measures to Facilitate the Export of Pharmaceutical Products

Firstly, the scope of the export certificate is expanded. For the exported pharmaceutical products manufactured in accordance with GMP by pharmaceutical manufacturers, an export certificate can be applied, regardless of whether the products have been approved for marketing in China or not.

Secondly, the validity period of the export certificate is standardized. The validity period of the Certificate of a Pharmaceutical Product is adjusted from 2 years to 3 years, which is consistent with the Written Confirmation for Active Substances Exported to the European Union (EU). Provincial drug regulatory authorities shall provide services during the handling of the application for export certificates to ensure that the application for certificate renewal before the expiry date is handled in an orderly manner, thus avoiding the "gap period", where the old certificate has expired but the new certificate has not yet been issued. If the regulatory authorities in importing countries (regions) consider that the existing certificates have been issued earlier (e.g., more than 18 months) and expect the manufacturers to provide a new certificate, the manufacturers may apply for a new certificate, and the provincial drug regulatory authorities shall handle the application according to the procedures.

Thirdly, the time limit for issuing certificates is specified. The Provisions clearly require that the time limit for handling the application for an export certificate in the work rules set by each provincial drug regulatory authority shall not exceed 20 working days. However, the time required for technical review, evaluation, on-site inspection by the drug regulatory authorities, and any time needed for manufacturer rectification shall not be counted into the time limit.

Fourthly, an export certificate can be applied for intermediate products of pharmaceutical preparations. When intermediate products of pharmaceutical preparations (including drug substances of biological products) manufactured by pharmaceutical manufacturers have been exported and used for the production of pharmaceutical preparations in the importing countries (regions), if the regulatory authorities in the importing countries (regions) require an export certificate for these intermediate products of pharmaceutical preparations, an export certificate can be applied according to the types of products that have not been marketed within the territory of China. For pharmaceutical manufacturers producing and exporting pharmaceutical intermediate products, if their Drug Manufacturing License does not include this intermediate product in its production scope, they should ensure that the manufacturing scope includes the relevant pharmaceutical preparation. There is no need to apply for an extension of the production scope to include the intermediate product specifically.

Fifthly, the template of the Certificate of a Pharmaceutical Product is updated. The template of Certificate of a Pharmaceutical Product adopts the latest format recommended by the World Health Organization (WHO), issued in 2021, to align with the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. Applicants for the Certificate of a Pharmaceutical Product shall carefully understand the changes in the template format and the latest requirements for filling and application.

IV. Measures to Ensure the Production Compliance of Exported Pharmaceutical Products

To comply with WHO's assessment requirements for National Regulatory Authorities (NRAs) and to join the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the Provisions specify the compliance and inspection requirements for the production of exported pharmaceutical products. The relevant measures include:

Firstly, pharmaceutical manufacturers are guided to establish dossiers for exported pharmaceutical products, with inspections based on the information in such dossiers. The exported pharmaceutical product dossiers serve as the information foundation for the production management of exported pharmaceutical products by the manufacturers, as well as a key tool for regulatory inspection of exported pharmaceutical products.

Secondly, targeted inspections can be conducted based on the export certificate. The export certificate contains proof information such as GMP compliance for specific products or dosage forms, and the inspection period. For pharmaceutical products that have obtained export certificates, on the basis of regulating the overall compliance of manufacturers, the provincial drug regulatory authorities may conduct more targeted inspections in combination with the export certificate information.

Thirdly, an extended inspection may be conducted, when necessary, for storage and transportation companies of exported pharmaceutical products within the territory of China. The Provisions require that entities involved in exporting pharmaceutical products, such as manufacturers of exported pharmaceutical products or entrusting parties entrusting the manufacturing of exported pharmaceutical products, shall ensure that storage and transportation companies of the exported pharmaceutical products are subject to audits and extended inspections by the drug regulatory authorities through the letter of commitment, storage and transportation agreements, etc. This measure helps ensure the quality of exported pharmaceutical products and the rights and interests of overseas patients in medication safety.

V. Description for the Information Related to the Exported Pharmaceutical Products in the Drug Manufacturing License

After the implementation of the Provisions, when applying for the issuance, change, or renewal of the Drug Manufacturing License, where the applicants have the designated production scopes, production workshops, and production lines for exported pharmaceutical products, they shall apply for GMP compliance inspection of exported pharmaceutical products at the same time. Manufacturers can submit the application at their own time, which shall be no later than the time point at which they apply for changes to license items related to pharmaceutical products marketed domestically for the first time after the implementation of the Provisions. Where no change occurs to license items after the implementation of the Provisions and before the manufacturers apply for renewal of the Drug Manufacturing License, they can apply together at the time of renewal of the license. Where a manufacturer applies for an export certificate, the manufacturing site, production scope, production workshop, and production line of the relevant exported pharmaceutical products shall first be specified in the Drug Manufacturing License.

With reference to the Provisions for the Supervision and Administration of Drug Manufacturing and Announcement of the National Medical Products Administration on the Issues Pertaining to Implementation of the Newly Revised Provisions for the Supervision and Administration of Drug Manufacturing ([2020] No. 47), the provincial drug regulatory authorities shall review the production conditions of pharmaceutical manufacturers, conduct GMP compliance inspections, and, for those complying with GMP, specify the relevant manufacturing site, production scope, production workshop, production line and other information of exported pharmaceutical products in the Drug Manufacturing License.

VI. Description for Filling and Application Related to the Exported Pharmaceutical Product Dossiers

The information of the exported pharmaceutical product dossiers filled in by manufacturers in the information system of drug regulatory authorities is not part of the content that requires approval or filing by the drug regulatory authorities.

The materials to be kept by manufacturers themselves, namely, those under Items (14) and (15) of Article 14 of the Provisions, shall always be included in accordance with the requirements for each item of the exported pharmaceutical product dossiers.

The exported pharmaceutical product dossiers shall accurately reflect the status of manufacturing and sales of the exported pharmaceutical products of the manufacturers. Where a manufacturer establishes and updates the exported pharmaceutical product dossiers (including changes to the dossier information), it shall complete this within the relevant time limit specified in Article 16 of the Provisions.

The entities responsible for establishing exported pharmaceutical product dossiers shall establish the relevant exported pharmaceutical product dossiers after starting a new business of exported pharmaceutical products. "New business of exported pharmaceutical products" includes: obtaining the marketing authorization certificates from the importing countries (regions) for the products held by the exported pharmaceutical product manufacturers, signing an agreement for contract manufacturing (for the production of pharmaceutical products marketed in the importing countries or regions), etc. Before the implementation of the Provisions, where the business of exported pharmaceutical products has been terminated, there is no need to establish relevant exported pharmaceutical product dossiers.

The entities responsible for establishing exported pharmaceutical product dossiers shall strengthen the management of changes to dossier information. For example, if products for which shared facilities are used for production are added, the risk assessment of production in shared facilities shall be re-conducted, and a new assessment report shall be formed; where the legal representative is changed, the legal representative after the change shall re-sign the compliance statement of exported pharmaceutical products.

Where the same pharmaceutical product is exported to multiple countries (regions), and the relevant information (such as the generic name, trade name, specification, label, and package insert) is inconsistent among the importing countries (regions), the relevant information of the pharmaceutical product in each importing country (region) shall be filled in under the relevant items of the exported pharmaceutical product dossier.

The Provisions require that the information on the annual manufacturing and sales volume of exported pharmaceutical products in the previous natural year shall be filled in before April 30 of each year. The annual manufacturing and sales volume in 2025 shall be filled in by April 30, 2026.

For exported pharmaceutical products purchased by international organizations but have not obtained marketing authorization from the importing countries (regions), relevant documents that meet the procurement requirements of the international organizations shall be provided or retained under items involving the importing country (region), including Items (III), (IV), (VII) and (XIV) of the exported pharmaceutical product dossiers.

VII. Description for "International Organizations That Have Signed Relevant Agreements with Chinese Regulatory Authorities"

"International organizations that have signed relevant agreements with Chinese regulatory authorities" currently refer to the WHO and the Medicines Patent Pool (MPP). In order to serve manufacturers and save regulatory resources, for pharmaceutical products that have not been marketed within the territory of China and have obtained WHO pre-certification or MPP authorization for production, the provincial drug regulatory authorities may specify the manufacturing site, production scope, production workshop and production line of the relevant exported pharmaceutical products in the Drug Manufacturing License according to the application of manufacturers, and exempt on-site inspection for the relevant products during the process of handling the application for the Certificate of a Pharmaceutical Product.

It should be noted that, where the manufacturing site, production scope, production workshop and production line that are exclusively used for the exported pharmaceutical products are intended to be used subsequently for production of pharmaceutical products to be marketed within the territory of China, the manufacturers of exported pharmaceutical products shall apply for the changes to Drug Manufacturing License in accordance with the relevant requirements for pharmaceutical products to be marketed within the territory of China.

VIII. Description for Exemption from Inspection during the Process of Handling the Application for Written Confirmation for Active Substances Exported to the European Union (EU)

Where the pharmaceutical manufacturer has passed the GMP inspection by the WHO, the European Directorate for the Quality of Medicines & Healthcare (EDQM) and the drug regulatory authorities of the EU member states, the provincial drug regulatory authorities may exempt it from on-site inspection during the process of handling the application for Written Confirmation for Active Substances Exported to the European Union (EU), and indicate the authority that conducts the GMP inspection in the Written Confirmation.

IX. Description for "Information System Built by Drug Regulatory Authorities" in the Provisions

"Information system built by drug regulatory authorities" refers to the pharmaceutical product business application system of NMPA and the self-built systems of the provincial drug regulatory authorities. Among them, the pharmaceutical product business application system of NMPA is divided into categories of information collection, review, approval, and filing.

The pharmaceutical product business application system (information collection) is used to fill in the information and materials required in Items (1) to (13) of Article 14 of the Provisions. Users shall access the operation manual available on the "Help Document" for the specific operation process. As of December 1, 2025, the filling and application function of exported pharmaceutical product dossiers of this system will be available in all provinces nationwide.

The pharmaceutical product business application system (review, approval, and filing) is used to apply for an export certificate. After registering and completing real-name authentication in the NMPA government affairs service portal, the applicants may apply for an export certificate. Once the export certificate is obtained, it can be viewed or downloaded electronically in the "My License" section of the legal person space or on the "NMPA APP". It should be noted that the export certificate falls under a service item, not under a review, approval, and filing item. The export certificate applications accepted before the implementation of the Provisions shall be handled in accordance with the original relevant provisions and templates.

Provincial drug regulatory authorities may, based on the work needs of their respective provinces, establish their own systems for filling in and submitting exported pharmaceutical product dossiers and handling applications for export certificates. The specific launch date and operation process of self-built systems shall be subject to the requirements of the corresponding provincial drug regulatory authorities. Before the launch of the self-built systems of provincial drug regulatory authorities, manufacturers shall use the pharmaceutical product business application system of the NMPA to fill in and submit exported pharmaceutical product dossiers and apply for export certificates within the specified time limit. After the self-built systems of provincial drug regulatory authorities are launched, they shall be connected to the NMPA system to exchange information on exported pharmaceutical product dossiers and export certificates.

X. Description for Application for Certificate of a Pharmaceutical Product in the Case of Cross-Provincial Contract Manufacturing

Where an exported pharmaceutical product has been marketed within the territory of China or an application for marketing authorization has been submitted, and cross-provincial contract manufacturing is involved, the entrusting party may choose one of the following two application methods based on its own needs: The first is to apply to the provincial drug regulatory authority in the place where the entrusting party is located, and the provincial drug regulatory authority in the place where the entrusting party is located shall issue the certificate based on the GMP compliance inspection results of the entrusted manufacturer in another province after inquiring; The second is that the entrusting party shall issue the Statement of Entrusting for Application for Certificate of a Pharmaceutical Product in accordance with the template attached to the Provisions, and the entrusted manufacturer shall apply to the provincial drug regulatory authority in the place where it is located to issue a certificate.

XI. Description of the Relevant Regulations for the Exportation and Undertaking Contract Manufacturing of Exported Narcotic Drugs, Psychotropic Substances, Preparations Containing Narcotic Drugs or Psychotropic Substances, Pharmaceutical Precursor Chemicals, Preparations Containing Pharmaceutical Precursor Chemicals, and Protein Anabolic Preparations and Peptide Hormones Listed in the Stimulant Catalog

According to the relevant requirements of the Drug Administration Law, export licenses shall be obtained for narcotics and psychotropic drugs to be exported. In accordance with the relevant requirements of the Measures for the Administration of the Production of Narcotic Drugs and Psychotropic Substances (Interim) (GSYJA [2005] No. 528), where the exported pharmaceutical product manufacturers undertake contract manufacturing of narcotic drugs, psychotropic substances, and preparations containing narcotic drugs or psychotropic substances entrusted by the overseas marketing authorization holders and applicants, approval from the NMPA shall be obtained. The pharmaceutical products that have been approved for production shall not be sold or used within the territory of China in any form, and shall be completely exported after obtaining an export license. According to the relevant requirements of the Regulations on the Management of Precursor Chemicals, export licenses issued by the commercial authorities shall be obtained for the export of pharmaceutical precursor chemicals. In accordance with the relevant requirements of the Measures for the Administration of Pharmaceutical Precursor Chemicals (Order No. 72 of the Ministry of Health), pharmaceutical manufacturers shall not undertake contract manufacturing of pharmaceutical precursor chemicals and preparations containing pharmaceutical precursor chemicals entrusted by overseas manufacturers for export. In accordance with the relevant requirements of the Anti-Doping Regulations, the Decision of the State Council on Canceling and Adjusting the Sixth Batch of Administrative Approval Items (GF [2012] No. 52) and the Notice on Further Strengthening the Export Management of Overseas Contract Manufacturing of Protein Anabolic Preparations and Peptide Hormones (SYJYHJ [2013] No. 226), where the exported pharmaceutical product manufacturers undertake the contract manufacturing of protein anabolic preparations and peptide hormones listed in the stimulant catalogue entrusted by overseas marketing authorization holders and applicants shall not organize production until obtaining an export license.