Districts People’s Governments and all relevant entities:

To drive the innovative development of the city’s biomedicine industry, foster new growth drivers, and further advance the marketization and industrialization of innovative pharmaceuticals and medical devices (hereinafter referred to as innovative drug and device products), in accordance with the spirit and work requirements of documents including the Several Policy Measures of Guangzhou Municipality for Promoting High-Quality Development of the Biomedicine Industry (Sui Fu Ban Gui〔2024〕No.1), we hereby launch the collection of innovative pharmaceutical and medical device products in Guangzhou. Relevant arrangements are specified as follows:

I. Eligible Applicants

（一）The applicant shall be the Marketing Authorization Holder (MAH) of the product, capable of independently bearing civil liabilities, with a sound credit record and complete financial accounting systems.

（二）Either the MAH or all domestic manufacturers of the product shall be enterprises, public institutions or new-type R&D institutions legally registered in Guangzhou, and shall conduct substantial biomedicine-related activities within Guangzhou, including R&D, clinical trials, achievement transformation, production & operation, and service management.

II. Application Requirements

（一）Each applicant may submit a maximum of 5 products.

（二）The product has obtained marketing approval and meets all the following basic criteria: (1) For pharmaceutical products: They shall be biological products newly approved for marketing or approved for new indications after July 1, 2022, Class 1 and Class 2 chemical drugs, or Class 1 and Class 2 traditional Chinese medicines. Imported original drugs with exclusive domestic marketing approval whose production has been transferred to domestic manufacturers shall be deemed Class 1 drugs. (2) For medical devices: They shall satisfy any one of the following conditions: ① Class III medical devices approved after July 1, 2022; ② Class II medical devices approved after July 1, 2022 whose core technologies have won provincial or national Science and Technology Awards; ③ Imported medical devices with exclusive domestic marketing approval whose production has been transferred to domestic manufacturers; ④ Products approved for marketing via the national or provincial innovative product registration pathway or priority registration pathway. (3) The product shall be covered by valid invention patents or utility model patents. The applicant shall either own the patent rights or hold an exclusive license for patent implementation. The remaining valid term of the patent or licensing right shall exceed 4 years with clear ownership.

（三）Products that meet the above basic criteria and any of the following conditions shall be prioritized for inclusion by tier:

 (1) Drugs that have entered the Breakthrough Therapy Designation pathway or Priority Review and Approval pathway; 

(2) Globally first approved products or domestically first import-substituted products; 

(3) Drugs covered by the National Medical Insurance Negotiation List within the valid agreement term; (4) Products developed from projects that have passed acceptance of major municipal or above science and technology special programs; 

(5) Products certified by international authorities including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA, Japan), Therapeutic Goods Administration (TGA, Australia); 

(6) Products manufactured by enterprises certified as High-tech Enterprises, Specialized, Refined, Unique & Innovative Enterprises (Innovative SMEs, SRUI SMEs, SRUI "Little Giant" Enterprises), Guangzhou Headquarters Enterprises, or Manufacturing Single Champion Enterprises.

III. Supplementary Notes

（一）This application is competitive. Our Bureau will organize joint reviews with relevant authorities, and finalize the list of selected products upon approval via formal procedures.

（二）The valid inclusion term for selected innovative products is generally two years. Products within the valid term do not need to reapply, and their eligibility will automatically expire upon term end, requiring a new application for renewal.

（三）A single innovative product may not be included for more than four years in total. No reapplication will be accepted for the same product after the four-year period expires.

IV. Document Submission Requirements

（一）Applicants shall fill out application materials in the prescribed format strictly in accordance with this circular, and submit all supporting attachments. Submissions failing to comply with the provisions will be deemed to have failed the preliminary formal review. Applicants shall bear full responsibility for the authenticity, accuracy and legality of all submitted projects and materials.

（二）Each district shall conduct preliminary review of all submitted products, summarize qualified projects, fill out the Summary Form of Recommended Products (Appendix 1) with the official seal of the district competent authority, and submit it together with an official recommendation letter.

（三）Applicants shall prepare the following documents: 

① Cover Page (Appendix 2)

② Document Index Table (Appendix 3, listing the name of each supporting document and its corresponding page number in the application dossier) 

③ Application Undertaking Letter (Appendix 4) 

④ Copy of the legal representative’s ID card (passport for foreign nationals) 

⑤ Application Form for Innovative Pharmaceuticals in Guangzhou (Appendix 5) or Application Form for Innovative Medical Device Products in Guangzhou (Appendix 6) 

⑥ 2025 annual financial audit report of the applicant 

⑦ Copies of official legal documents: business licenses of the applicant and all product manufacturers, product registration certificates, production licenses, intellectual property right certificates, etc. 

⑧ Product photographs: front-view photos, as well as photos showing the name of the marketing authorization holder, manufacturers, registered address and production address. 

⑨ Copies of supporting certification materials, including but not limited to:

• Innovation credentials: authorized patents, exclusive patent licensing contracts, major award certificates;Clinical advantages: clinical trial conclusions, breakthrough therapy designation, optimized clinical diagnosis and treatment pathways, priority review approval records, inclusion in clinical guidelines, diagnostic standards or expert consensus;

• Technical leadership: provincial or higher-level awards, solutions to core bottleneck technologies, major breakthroughs in performance, materials or design;

• Import substitution credentials: global first approved products, provincial or national first import-substituted products.

• ⑩ For domestic-manufactured original drugs: the corresponding batch’s List of Reference Listed Drugs for Generic Drugs shall be attached.

• ⑪ Other supplementary materials (if applicable): supporting documents proving priority eligibility, honor certifications at municipal level or above, and other highlight materials.

V. Application Guidelines

(I) Application Channel

1.All submissions for this product database shall be completed online.

2.Applicants shall submit applications via the Guangzhou Special Industrial Development Fund Project Management System (hereinafter referred to as the Application System, URL: http://shenbao.gxj.gz.gov.cn/). Technical Support Hotline: 020-83757015; QQ Customer Service: 1428954896. The full set of application documents shall be uploaded online.

(II) Detailed Application Timeline & Procedures

1.Enterprise Application Period: 09:00, July 16 – 17:00, August 15 (1) Account Registration: The system no longer supports new registration of enterprise administrator accounts within the system. Enterprises with existing legal representative accounts on the Guangdong Provincial Unified Identity Authentication Platform (https://tyrz.gd.gov.cn/) may log in directly; the system will automatically bind existing administrator accounts. Enterprises without existing accounts shall register on the Provincial Unified Identity Authentication Platform. Upon first login redirected to this system, complete verification of enterprise basic information to finish administrator account registration, then create project submitters under the "Submitter Management" module. Entities with pre-registered system accounts may log in directly without re-registration. (2) Form Filling: Log in with a project submitter account to complete project information, then submit to the enterprise administrator for internal review. (3) Online Submission: After internal review by the enterprise administrator, submit the application to the district competent authority via the system. The application portal opens at 09:00 on July 16 and closes at 17:00 on August 15. All initial online submissions must be completed before the deadline; late submissions will not be accepted. If the district authority returns the project for revision, all revised materials must be resubmitted by 16:00 on August 20, after which the submission portal will be permanently closed.

2.District Competent Authority Work Period: 09:00, July 16 – 18:00, August 20 (1) Preliminary Review: Districts shall review all enterprise submissions between July 16 and August 15. If materials require revision or supplementation, all review operations must be finalized and submitted in the system by 18:00 on August 20, after which the review portal will close. (2) Document Submission: After preliminary review, districts shall submit the official recommendation letter and completed Summary Form of Recommended Products (Appendix 1) with official department seals to our Bureau no later than August 25. (3) System Confirmation: Confirm all submitted projects in the online system and upload scanned copies of all physical submission documents.

Appendices

1.Summary Form of Recommended Products (for submission by district competent authorities)

2.Cover Page

3.Document Index Table

4.Application Undertaking Letter

5.Application Form for Innovative Pharmaceuticals in Guangzhou

6.Application Form for Innovative Medical Device Products in Guangzhou

Bureau of Industry and Information Technology of Guangzhou Municipality July 15, 2026 Contact Hotline: 020-83726616 Ext. 8003

Friendly Reminder

To view or download all appendices, visit the official website of the Bureau of Industry and Information Technology of Guangzhou Municipality (http://gxj.gz.gov.cn/) or click "Read More" at the bottom left of the page.