District Governments and Relevant Units:

To promote the innovative development of Guangzhou’s biopharmaceutical industry, accelerate the cultivation of new drivers, and further advance the marketization and industrialization of the city’s innovative pharmaceutical and medical device products (hereinafter referred to as "products"), in accordance with the spirit and work requirements of documents such as Several Policy Measures for Promoting High-Quality Development of the Biopharmaceutical Industry in Guangzhou (Sui 府办规〔2024〕1 号), we are now launching the collection work for the second batch of the Guangzhou Innovative Pharmaceutical and Medical Device Product Catalog. Details are as follows:

I. Applicant Entities

1. The applicant entity shall be the holder of the product’s registration license, with the ability to independently assume civil liabilities, a good credit record, and a sound financial and accounting system.

2. The holder of the product’s registration license or all production units shall be enterprises, public institutions, or new R&D institutions legally registered in Guangzhou, and shall substantially engage in biopharmaceutical R&D, clinical trials, achievement transformation, production and operation, and service management in Guangzhou.

II. Application Requirements

1. Each applicant entity may apply for no more than 5 products.

2. The product shall have been approved for marketing and meet the following basic conditions:

• For pharmaceutical products: Approved for marketing by the national drug regulatory authority for the first time on or after July 1, 2021; or biological products, Class 1/2 chemical drugs, or Class 1/2 traditional Chinese medicines approved for new indications.

• For medical devices: Meeting any of the following conditions: (1) Class III medical devices approved on or after July 1, 2021; (2) Class II medical devices whose core technologies have won national or provincial science and technology awards and were approved on or after July 1, 2021; (3) Imported medical devices transferred to domestic production that are the only ones approved in China; (4) Products approved for marketing through national or provincial innovative product registration procedures or priority registration procedures.

• The product shall have valid invention patents or utility model patents with a term of more than 4 years, with the applicant entity as the patentee and clear rights status.

3. Products meeting the basic conditions and any of the following criteria will be prioritized for inclusion in the catalog by classification:

• Drugs included in breakthrough therapy procedures or priority review and approval procedures.

• The world’s first approved product or China’s first import-substituting product.

• National medical insurance negotiated drugs within the agreement period.

• Products from projects that have passed acceptance for municipal or higher-level major science and technology projects.

• Products certified by international authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Japan Pharmaceuticals and Medical Devices Agency (PMDA), or Australian Therapeutic Goods Administration (TGA).

• Products of enterprises recognized as high-tech enterprises, specialized and sophisticated enterprises (innovative SMEs, specialized and sophisticated SMEs, "little giant" enterprises), Guangzhou headquarters enterprises, or manufacturing single-item champion enterprises.

III. Other Instructions

This application is a competitive process. Our bureau will collaborate with relevant departments to evaluate the applied products, determine the selected products after approval in accordance with procedures. The catalog is generally valid for two years. Selected products within the validity period do not need to reapply; their eligibility will automatically expire upon expiration, and reapplication is required. The same product may be included in the catalog for a maximum of four years. After four years, the same product will no longer be accepted for application.

IV. Documentation Requirements

1. Applicant entities shall fill in the application materials in the specified format in strict accordance with this notice and submit relevant attachments. Applications failing to submit materials as required will be deemed 不合格 in formal review. Applicant entities shall be responsible for the authenticity, accuracy, and legality of the application projects and materials.

2. Districts shall conduct preliminary reviews of the applied products, summarize the projects that pass the preliminary review, fill in the Summary Table of Recommended Products (Annex 1), affix the official seal of the district competent authority, and submit it together with a recommendation letter.

3. Applicant entities shall provide the following materials:

• Cover page (Annex 2).

• Index table of materials (Annex 3, indicating the names of relevant project materials or supporting documents and their page numbers in the application).

• Application commitment letter (Annex 4).

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

• Guangzhou Innovative Drug Application Form (Annex 5) or Guangzhou Innovative Medical Device Application Form (Annex 6).

• 2024 financial audit report of the applicant entity.

• Objective documents (copies): Business licenses of the applicant entity and all product production units, product registration certificates, product production licenses, certificates of independent intellectual property rights, etc.

• Product photos: Front photos, photos showing the name of the marketing authorization holder, production enterprise, registration address, and production address, etc.

• Relevant supporting materials (copies): Explanations and supporting documents regarding product innovation (including but not limited to authorized patents, certificates of major awards), clinical advantages (including but not limited to inclusion in breakthrough therapy procedures, improved diagnosis and treatment methods, clinical innovation in priority review and approval procedures; inclusion in clinical guidelines, diagnosis and treatment standards, or expert consensus), technological leadership (e.g., awards from provincial or higher administrative departments, solving "bottleneck" issues, major breakthroughs in performance, materials, or design), import substitution (e.g., the world’s first approved product, China’s first or Guangdong’s first import-substituting product), etc.

• Other relevant materials (if available): Supporting documents for meeting the criteria for priority inclusion in the catalog, other highlights (e.g., municipal or higher-level honorary certifications obtained by the product), etc.

V. Application Guidelines

1. Application Channel

• This application is conducted online. The electronic version of the application guidelines can be viewed on the website of the Municipal Bureau of Industry and Information Technology.

• Applicant entities must apply online through the Guangzhou Industrial and Information Technology Development Special Fund Project Management System (hereinafter referred to as the "Application System", http://shenbao.gxj.gz.gov.cn/; technical support hotline: 020-83757015; technical support QQ customer service: 1428954896). The application materials shall include all required documents.

2. Specific Application Process

• Enterprise Application Process: (9:00 on June 26 – 17:00 on July 16)
  (1) Registration: The special fund management system no longer provides enterprise administrator account registration. If an enterprise already has a legal person account on the "Guangdong Provincial Unified Identity Authentication Platform" (https://tyrz.gd.gov.cn/), it can log in with the existing legal person account, which will be automatically linked to the existing administrator account in the special fund management system. For new enterprise administrator accounts, registration is required on the "Guangdong Provincial Unified Identity Authentication Platform". When logging in to this system from the platform for the first time after registration, enterprises shall supplement and verify basic enterprise information to complete the registration of the administrator account in the special fund management system, then click "Applicant Management" to create project applicants for the entity. Units that have already registered in the application system can log in with their original accounts without re-registration.
  (2) Filling in: Log in with the project applicant account to fill in project details and submit for review by the enterprise administrator.
  (3) Online submission: After review by the enterprise administrator, submit to the district for preliminary review through the system. The application system opens at 9:00 on June 26 and closes at 17:00 on July 16. Enterprises must complete the first online submission by 17:00 on July 16; late submissions will not be accepted. If the project is returned by the district competent authority for revision, it must be revised and resubmitted by 17:00 on July 18, after which the system will close the submission channel.

• District Competent Authority Workflow: (9:00 on June 26 – 18:00 on July 21)
  (1) Preliminary review: From June 26 to July 16, district competent authorities shall review enterprise application materials. If materials need to be returned to enterprises for revision or supplementation, the review and submission must be completed in the system by 18:00 on July 21, after which the system will close the review channel.
  (2) Submission of application materials: After review, district competent authorities shall submit the recommendation letter and project summary table (Annex 1) (both affixed with official seals) to our bureau by July 23.
  (3) System confirmation: Confirm the submitted projects in the application system and upload scanned copies of the submitted documents.

Annexes:

1. Summary Table of Recommended Products (submitted by district competent authorities)

2. Cover Page

3. Index Table of Materials

4. Application Commitment Letter

5. Guangzhou Innovative Drug Application Form

6. Guangzhou Innovative Medical Device Application Form

Guangzhou Bureau of Industry and Information Technology
June 24, 2025

(Contact number: 83726616 ext. 8013/8002)

Kind Reminder
To view or download the annexes, please visit the website of the Guangzhou Bureau of Industry and Information Technology (http://gxj.gz.gov.cn/).