Hainan Launches Rapid Implementation of 21 Measures to Advance Digital Therapeutics, Opens Call for Clinical Trial Center Applications

On October 14, the Hainan Provincial Health Commission issued the “Notice on Organizing the Application for the Establishment of the Hainan Provincial Digital Therapeutics Clinical Trial Center.” The notice provides specific arrangements regarding the application content, targeted disease areas, basic eligibility criteria, construction objectives, application and approval procedures, and other requirements.

Earlier that day, relevant departments in Hainan Province held a press conference to provide an official interpretation of the “Several Measures for Accelerating the Development of the Digital Therapeutics Industry in Hainan Province.”

Notably, the “Notice” represents the first concrete implementation measure released following the issuance of the “Measures,” with only a four-day interval between the two, underscoring the unique development acceleration of the Hainan Free Trade Port. According to the plan outlined in the “Measures,” additional specific implementation measures are expected to be rolled out throughout the year.

The full text of the Notice is as follows:

Notice of the Hainan Provincial Health Commission on Organizing the Application for the Establishment of the Hainan Provincial Digital Therapeutics Clinical Trial Center

To the Health Commissions of all cities, counties, and autonomous counties; the Administration Bureau of Boao Lecheng International Medical Tourism Pilot Zone; Hainan Medical University and its affiliated hospitals; all units directly under the Commission; and all relevant entities:

To thoroughly implement the spirit of General Secretary Xi Jinping’s speech at the ceremony commemorating the 30th anniversary of the establishment of Hainan Province and its special economic zone, which called on Hainan to deepen supply-side structural reform, leverage its advantages, gather innovative factors, and actively develop the next-generation information technology industry and the digital economy, and in accordance with the deployment arrangements outlined in the “Several Measures of Hainan Province for Accelerating the Development of the Digital Therapeutics Industry,” we aim to advance the construction of a nationally leading clinical research demonstration base for digital therapeutics. To this end, we intend to launch the application process for the Hainan Provincial Digital Therapeutics Clinical Trial Center (hereinafter referred to as the “Trial Center”). Notice is hereby given regarding the relevant matters:

I. Application Content

Hainan Digital Therapeutics Clinical Trial Center (hereinafter referred to as the "Trial Center")

II. Disease Areas for Declaration

Focusing on key disease areas and technical fields suitable for digital therapeutics, such as respiratory diseases, neurological disorders, endocrine, nutritional, and metabolic diseases, circulatory system diseases, mental, behavioral, and cognitive disorders (including sleep disorders, etc.), ophthalmic diseases, and oncological conditions.

III. Basic Eligibility Requirements

(I) Entities applying for the “Clinical Trial Center” designation shall, in principle, be tertiary hospitals within the province with independent legal person status. They must possess clinically advanced diagnostic and therapeutic capabilities that are leading within the province and advanced nationwide, demonstrate prominent professional strengths, and have sufficient patient caseloads to ensure the smooth implementation of clinical trial research projects.

(2) The talent pipeline in relevant clinical departments is stable and well-structured. There is outstanding capability in clinical medicine and translational research within the declared field, with extensive experience in clinical trials of drugs and medical devices (see attached basic information on undertaken drug and medical device clinical trial projects). In the past five years, the institution has served as the lead investigator for at least one national-level science and technology program project or at least three provincial/ministerial-level science and technology program projects related to the declared field. The head of the clinical trial center shall hold a senior professional title and have served as the principal investigator for at least one provincial/ministerial-level or higher science and technology program project in the past five years.

(3) Possessing the qualification of a medical device clinical trial institution. Priority will be given to national and provincial key specialty construction units; medical institutions undertaking major new drug development projects; and provincial engineering research center construction units.

(4) Priority shall be given to tertiary specialized hospitals in the field of mental health and psychiatric care. If they do not possess the qualifications for medical device clinical trial institutions, they may jointly apply with qualified provincial-level tertiary hospitals.

(5) The undertaking entity shall be capable of providing the necessary conditions to support the construction of the proposed center, including the allocation of dedicated clinical research personnel, research facilities, instrumentation and equipment, and financial support.

IV. Development Objectives

(I) Disease Diagnosis, Treatment, and Achievement Transformation: Complete the key research tasks of the center as outlined in the application proposal, and translate into practice a batch of disease diagnosis and treatment protocols with distinctive therapeutic efficacy and ease of promotion and application.

(2) Evaluation and Translation of Digital Therapeutics: Actively conduct clinical research and evaluation of digital therapeutics, and promote the clinical translation of key technologies and products.

(3) Technological Innovation and Scientific Research Breakthroughs: Building on the existing foundation, accelerate technological innovation in the center’s advantageous disciplines, conduct key research on digital therapeutics, and actively undertake scientific research projects at or above the provincial level.

(4) Build specialized service platforms: Establish collaborative research networks and actively complete high-quality research on clinical diagnosis and treatment standards for digital therapeutics.

V. Application Process and Approval

(I) Applications shall be submitted in both hard copy and electronic format. Applicant institutions are required to submit the “Application Form for Hainan Provincial Digital Therapeutics Clinical Trial Center” (Attachment 1) along with supporting materials, with five copies of the hard copy materials. The hard copies shall be delivered to the Science and Education Division of the Commission by October 20, 2022, and the electronic version shall be sent to the email address: kjc_hnswjw@hainan.gov.cn.

(II) Recommending entities shall make recommendations based on actual construction needs, taking into account the overall requirements for the establishment of the testing center, and commit to providing continuous and stable conditions and funding guarantees necessary for construction during the construction period.

(3) Projects will be approved based on merit following evaluation.

VI. Application Requirements

The applicant entity bears primary responsibility for the authenticity of the project application and shall strengthen integrity management. The applicant entity, its legal representative, and the head of the clinical trial center shall have no adverse records in social credit or research integrity. The applicant entity and the person in charge of the application must ensure that the submitted materials are truthful, lawful, complete, and valid, and shall bear corresponding legal liabilities. The recommending entity shall focus on reviewing the authenticity, legality, and compliance of the application materials for the recommended “clinical trial center” and shall be held accountable thereof.

VII. Application Consultation and Contact Information

Hainan Provincial Health Commission Digital Therapeutics Task Force

Contact Person and Phone Number: Zhang Lei, 65388351;

Fu Jiaowen, 65391848.

Mailing Address: Hainan Provincial Health Commission, No. 38 Haifu Road, Meilan District, Haikou City, Hainan Province, Postal Code: 570203.

Attachment: Application for the Hainan Provincial Digital Therapeutics Clinical Trial Center

Hainan Provincial Health Commission

October 14, 2022