Addressing Key Challenges and Pain Points: 2023 Digital Therapeutics Product Registration and Regulatory Policy Forum to Be Held in Haikou
Recently, the digital therapeutics industry has been shaken by news concerning an overseas unicorn company. Nevertheless, the complementary value of digital therapeutics to traditional therapies remains intact. According to Gartner’s Hype Cycle for Emerging Technologies, every industry undergoes reshaping and integration of its value chain, which is an inevitable stage in the development of new technologies.
In this process of dynamic adjustment, policy guidance often serves as a stabilizing force for the industry. Notably, relevant departments in Hainan Province have taken the lead in introducing a series of policies to support the development of the digital therapeutics industry across “industry, academia, research, clinical practice, and inspection.”
To further promote the development of the digital therapeutics industry,The Hainan Provincial Medical Products Administration, the Digital Therapeutics Professional Committee of the China Association for Medical Devices Industry, and the Administrative Committee of Haikou National High-Tech Industrial Development Zone plan to jointly host the “2023 Summit Forum on Policies, Regulations, and Registration Approval for Digital Therapeutics Products” in Haikou from April 27 to 28, 2023.(hereinafter referred to as the “Forum”).
This forum will focus on discussions regarding the clinical research, registration submission, and review and approval of digital therapeutic medical device products, aiming to facilitate key steps for digital therapy companies to achieve market access.
It has become an industry consensus that digital therapeutics, in the full sense of the term, require integration with clinical trials. Against this backdrop, clinical trials for digital therapeutics in China have witnessed rapid growth in recent years.
According to incomplete statistics from VCBeat, there were only 13 clinical trials related to digital therapeutics in 2021. The number of clinical trials increased nearly threefold in 2022, reaching 37. In the first quarter of this year alone, 10 such clinical trials have been registered, representing a twofold increase compared to the same period last year.
Clinical trials underpin a series of activities related to the registration, review, and approval of digital therapeutics products. Therefore, for the entirely emerging digital health industry, the rapid growth in clinical trials also signifies the emergence of numerous systemic challenges.
First, due to the lack of unified clinical trial standards that align with the characteristics of digital therapeutics in the market, companies have lacked a profound understanding of the regulatory review framework for digital therapeutic medical devices. This has led to compliance issues with regulatory requirements during product registration and approval. As a result, many companies have taken detours or even wrong turns, delaying their market commercialization process.
Although numerous regulatory documents on digital health are currently available, merely reading these documents is often insufficient for companies to clearly understand how to get started, stillInterpretation and collaboration from regulatory agencies, registration specialists, and clinical professionals are required.
Furthermore, companies often conduct product research and development and regulatory registration sequentially rather than in parallel, indicating room for improvement in overall integration. As software-driven medical device products, digital therapeutics need to be addressed from the outsetConsider product development and market access from the perspective of a medical device quality management system. This is a systematic endeavor that requires careful consideration at every stage, including quality system establishment, project initiation, product testing, and clinical trials for registration.
To this end, the forum has invited leaders, industry experts, investment institutions, and corporate representatives from the Center for Medical Device Evaluation of the National Medical Products Administration, the Hainan Provincial Department of Industry and Information Technology, the Hainan Provincial Health Commission, the Hainan Provincial Healthcare Security Administration, the Haikou Municipal People’s Government, the Hainan Provincial Medical Products Administration, the Digital Therapeutics Professional Committee of the China Association for Medical Devices Industry, and the Haikou National High-Tech Industrial Development Zone, to jointly explore solutions to current challenges.
As a pioneer in digital therapeutics (DTx) policy, Hainan Province released 21 measures directly addressing the current pain points in the DTx industry’s development. It provided clear support and encouragement particularly in research, clinical application, promotion, and payment, becoming the first region in China—and indeed globally—to introduce comprehensive, full-lifecycle industrial support policies for digital therapeutics. It can be said that Hainan Province has set a robust example throughout the entire process from policy formulation to implementation, fully demonstrating its sincerity and determination.
Notably, the Hainan Provincial Medical Products Administration (MPA), as the primary regulatory authority, has been deeply involved in promoting the development of the digital therapeutics industry in Hainan Province. From establishing a cohort of clinical trial centers for digital therapeutics and public service and management platforms, to formulating guidance documents for classified regulation and registration approval of digital therapeutic products, creating a specialized channel for registration counseling of Class II medical device digital therapeutic products, issuing a catalog to encourage the development of digital therapeutics, and establishing a green approval channel for specific categories of digital therapeutics, and further to exploring a filing system for digital therapeutics and encouraging the application of real-world data in product registration, approval, and post-market clinical validation, the Hainan Provincial MPA has played a crucial role in providing guidance, support, and impetus.
On June 23, 2022, Kangai Medical, a high-tech enterprise specializing in innovative disease diagnostics and precision rehabilitation therapy, welcomed Hainan’s first listed digital therapeutics product. In addition to support from policies and relevant authorities, the Haikou National High-Tech Industrial Development Zone, where the company is located, has also drawn the attention of VCBeat.
It is reported that the Haikou National High-Tech Industrial Development Zone, serving as the “main stronghold” for the high-quality development of Hainan Free Trade Port’s biopharmaceutical industry, has gathered national Class A incubators and various types of innovation and entrepreneurship platforms. By establishing the Haikou National High-Tech Industrial Development Zone Pharmaceutical and Medical Device Innovation Service Station, the zone provides pharmaceutical and medical device enterprises with full-process professional consulting services, including product registration applications, on-site inspections, pre-review and pre-assessment, and post-market surveillance.
According to the 2022 Top 100 Biopharmaceutical Industrial Parks in China, Haikou National High-Tech Industrial Development Zone ranked 30th among 386 national-level industrial parks across the country, an improvement of 10 positions compared with 2020. Since the launch of the Hainan Free Trade Port initiative, the high-tech zone has signed agreements with 55 new pharmaceutical companies, including landmark projects such as Viatris, IQVIA, and Rohto.
Haikou National High-Tech Industrial Development Zone Digital Therapeutics Industrial Park
(Shichuanglian Innovation Workshop, International Science and Technology Innovation Center, Haikou High-Tech Zone)
The forum will also witness the unveiling ceremony of the Shichuanglian Innovation Workshop at the International Science and Technology Innovation Center of Haikou National High-tech Industrial Development Zone, marking the establishment of the Digital Therapeutics Industrial Park, as well as the signing ceremony with the first batch of enterprises settling in the park. In the future, Haikou National High-tech Industrial Development Zone and the Health Commission of Hainan Province will continue to provide support to accelerate the implementation of digital therapeutics initiatives, jointly explore innovative models for digital therapeutics in Hainan, create a favorable development environment for R&D enterprises, and deliver high-quality medical services to patients.
