2022-04-26

Beijing issues document: Conducting the initial review of clinical research institution and project filings for stem cells and somatic cells in 2022

The notice states: "Carry out the preliminary review of clinical research institutions and projects involving stem cells and somatic cells, strengthen policy advisory services, and provide pre-application guidance." Recently, the Beijing Municipal Health Commission released the "Notice on Issuing the 2022 Key Work Priorities for Health Science and Education in Beijing" on its official website. The notice emphasizes the importance of conducting thorough initial reviews for clinical research institutions and projects related to stem cells and somatic cells, while also enhancing policy advisory services and pre-application support. **Image** **Full Text:** **Key Work Priorities for Health Science and Education in Beijing, 2022** In 2022, Beijing’s health science and education initiatives will deeply implement the strategic plans for building the Beijing International Science and Technology Innovation Center and the city’s "Two Zones," aligning with national and municipal health science and education guidelines. Focusing on capacity building as the main driver and quality improvement as the core objective, these efforts aim to comprehensively advance health-related scientific innovation, accelerate innovative developments in medical education, strengthen the biosecurity assurance system, and foster sustained progress from both the perspectives of innovation and practical implementation. This will provide robust scientific and talent support for high-quality development of the capital’s healthcare sector. **I. Effectively Drive the Successful Implementation of COVID-19 Prevention and Control Research Projects** Initiate joint research projects aimed at evaluating the effectiveness of public health initiatives. Specifically, assess the outcomes of collaborative public health projects such as emergency COVID-19 testing, respiratory disease monitoring and early warning systems, molecular tracing efforts, protective and disinfection products, intelligent supervision of laboratory biosafety, 5G-based emergency medical information platforms, emergency blood supply strategies for public health crises, and integrated peacetime-wartime pandemic response frameworks. Conduct comprehensive analyses of project results and forecast their potential applications. **II. Fully Advance Scientific and Technological Innovation in Healthcare** **(1) Strengthen Clinical Research Capacity Building** Launch the third batch of demonstration projects for research-oriented wards, supporting Capital Medical University in establishing research-focused hospitals. Refine the evaluation index system for research-oriented wards, conduct comprehensive assessments of their development, and formulate reform plans tailored to research hospitals and specialized wards. Pilot the development of standardized local data elements for specific diseases, gradually rolling out standardized contract templates for select conditions to enhance the efficiency and quality of clinical research services. Additionally, encourage research-oriented wards to attract industry partnerships, thereby enabling the capital’s pharmaceutical and healthcare industries to play a unique and pivotal role. **(2) Enhance the System for Commercializing Scientific and Technological Achievements in Medical Institutions** Firmly implement the "Several Measures to Remove Bottlenecks in the Commercialization of Scientific and Technological Achievements from Universities, Institutes, and Medical Institutions in Beijing," refining working mechanisms, improving institutional frameworks, and organizing regular outreach activities that deliver policies, services, and opportunities for collaboration. Expand the scope of pilot programs allowing researchers to gain ownership or long-term usage rights over their institutionally-owned scientific and technological achievements. Adopt a multi-pronged approach to support clinical healthcare professionals in initiating and advancing technology transfer projects. Launch the second phase of collaborative innovation centers integrating medicine, research, and industry, and organize activities focused on promoting advanced scientific and technological achievements and appropriate medical technologies in 2022. **(3) Implement Specialized Research Programs for Capital Health Development** Refine management approaches and institutional frameworks for special research programs supporting capital health development under the new context. Complete project approvals for 2022 and fully kick off 494 research initiatives. Continue strengthening the Clinical Research Quality Promotion Center by leveraging the 36 newly accredited Beijing Clinical Research Quality Promotion Centers. These centers will implement a three-tiered quality control system—including self-assessments by project teams, institutional reviews, and independent third-party audits—while expanding and reinforcing audit and inspection teams. Optimize quality control processes to ensure higher standards throughout project execution. Conduct post-project evaluations, including acceptance checks, performance assessments, outcome tracking, and analysis of technology transfer trends, to gauge the overall impact of completed research endeavors. **(4) Enhance Industry-Specific Scientific Governance Capabilities** Deepen efforts to bolster ethical review capacities in biomedical research involving human subjects, further promoting mutual recognition of ethics review processes. Explore mechanisms for cross-regional recognition of ethics review outcomes between Beijing, Tianjin, and Hebei, and initiate capability assessments for ethics committees to develop region-specific governance models. Additionally, carry out preliminary reviews for clinical research institutions and projects involving stem cells and somatic cells, providing enhanced policy advisory services and pre-application guidance. Ensure compliance with national and municipal directives on strengthening research integrity, refining relevant management systems, and standardizing research practices. Initiate comprehensive audits of clinical research projects, conducting thorough evaluations and oversight to promote the proper conduct of clinical studies.(1) Reform and improve the process assessment, annual assessment, and graduation assessment systems, accelerating the pilot program for unified process assessments. Gradually enhance the standardization of process evaluations, while building on the foundation of objective and structured graduation exams. Explore diverse assessment methods, including piloting a phased, competency-based modular evaluation system. Additionally, establish an arbitration mechanism for clinical practice competency assessments to further enhance the objectivity of the evaluation process. (2) Steadily advance standardized training programs for specialist physicians. Develop and implement comprehensive training plans and supporting measures tailored to specialist physicians. Conduct graduation assessments for the first cohort of specialists trained in neonatal perinatal medicine and neurosurgery. Revise the integrated residency-specialist training programs for oncology (medical and surgical specialties), refining assessment methodologies that closely align with real-world clinical practice. Based on the national specialty catalog, refine training frameworks for endocrinology, gastroenterology, critical care medicine, orthopedics, urology, obstetrics and gynecology, ultrasound medicine, and diagnostic radiology. Simultaneously, drive the development of specialized training programs in fields such as general surgery, rheumatology-immunology, and oral and maxillofacial surgery, while also working on establishing clear standards for training facilities. (3) Strengthen capacity-building efforts for primary healthcare professionals. Implement the spirit of the "Beijing Implementation Plan for Reforming and Improving the Training and Incentive Mechanisms for General Practitioners," placing a strong emphasis on cultivating a robust team of general practitioners at the grassroots level. Expand training initiatives targeting assistant general practitioners, general practitioner faculty members, physicians transitioning into general practice roles, mandatory continuing education courses for community health technicians, on-the-job training for rural doctors, advanced training programs for key physicians from district-level hospitals, and targeted training programs for rural and village doctors under order-based agreements. Additionally, launch various other training initiatives designed to bolster the skills and expertise of primary healthcare personnel. (4) Enhance management of continuing medical education (CME). Comply rigorously with national CME management guidelines, reinforcing local accountability. Update and refine existing management protocols to elevate the standardization of CME administration. Align with the National Health Commission’s directives aimed at reducing administrative burdens on grassroots CME providers, exploring specific Beijing-based strategies—such as innovative approaches to remote CME delivery and flexible credit-granting mechanisms. Participate in the national "Verifiable Self-Study Model" initiative, piloting verifiable self-study methods within the Beijing region. Leverage "Internet + CME" initiatives by upgrading Beijing’s CME Management Information System (ICME), enhancing its functionalities for credit tracking, program management, and personnel oversight. Integrate advanced learning tools to transform the platform into a comprehensive information hub for healthcare professionals in Beijing, offering services ranging from educational training and learning record management to competency assessments. Furthermore, roll out online training and certification programs focused on infectious disease prevention and control, ensuring that CME offerings remain relevant, effective, and cutting-edge. Establish a dedicated expert panel of CME professionals to oversee the development of high-quality, specialized CME programs. Adopt a balanced approach to CME regulation—combining regulatory oversight with ongoing project monitoring and rigorous credit verification processes—to continuously elevate the quality of CME initiatives. Strengthen leadership capacities by organizing targeted management training sessions, fostering knowledge-sharing opportunities, and enhancing overall CME governance capabilities. (5) Explore and implement integrated training programs for hospital pharmacists and clinical pharmacists. Pilot the establishment of a unified training model for hospital and clinical pharmacists, refining both training curricula and collaborative management frameworks for training institutions. Strengthen efforts to build a robust faculty network and develop comprehensive course structures. (6) Continue advancing training and capacity-building efforts in public health-related fields. Solidify the foundational framework for integrating medical and public health practices, refining training standards, expanding access to essential resources, and bolstering healthcare IT infrastructure. Broaden pathways for graduate-level education in public health, including master’s and doctoral programs. Revise and enhance existing training frameworks for public health physicians, aligning them with national benchmarks. Initiate the accreditation process for collaborative public health training centers and clinical training sites, while simultaneously strengthening faculty development initiatives.

2022-03-23

The Ministry of Science and Technology releases the "Detailed Rules for the Implementation of the Regulations on Human Genetic Resources (Draft for Comments)"

To effectively implement the "Regulations on the Administration of Human Genetic Resources of the People's Republic of China," ensure that all provisions are fully put into practice, and further enhance the efficiency of human genetic resource management in China, the Ministry of Science and Technology has drafted the "Detailed Rules for the Implementation of the Regulations on the Administration of Human Genetic Resources (Draft for Public Comment)." These rules are now open for public consultation.

2022-03-11

A National People's Congress delegate has proposed: vigorously promoting the application and translation of stem cell technology, and establishing a national-level platform dedicated to advancing the entire stem cell industry chain.

Yang Keng suggests establishing a national-level promotion platform dedicated to the entire stem cell industry chain, addressing the core "patent technology pool," focusing on breakthroughs in critical technologies, and facilitating the seamless integration of upstream, midstream, and downstream industries—thereby effectively boosting the growth of the stem cell ecosystem.

2022-03-08

Cell therapy makes headlines at the 2022 Two Sessions across China! Stem cells emerge as a key direction in medical advancement.

Let’s take a look at what suggestions regarding stem cells have been submitted by people’s congress representatives, CPPCC members, and others from various regions!

2022-03-08

A member of the National Committee of the Chinese People's Political Consultative Conference has proposed moderately opening up diversified investments in areas such as stem cells and gene technology, aiming to strengthen and expand the bioeconomy.

To accelerate the development of China's biopharmaceutical industry, it is recommended that, on one hand, we moderately open up diversified investment in areas such as stem cells, gene diagnostics, and therapeutic technology development and application. On the other hand, we should refine and optimize the national centralized procurement policies, while giving special attention and support to companies independently developing innovative drugs—particularly those in the biopharmaceutical sector.

2022-03-08

Nine national ministries and commissions jointly issued a document: prioritizing the development of stem cell, immune cell, and gene therapy products.

Focus on developing immune cell therapies such as chimeric antigen receptor T cells (CAR-T) and chimeric antigen receptor NK cells (CAR-NK), which target novel targets and indications, along with stem cell therapies, gene therapy products, and specific immunoglobulins.

2022-03-08

National Committee of the Chinese People's Political Consultative Conference (CPPCC) 13th National Conference, Session 5: Commends Stem Cell Research for Pioneering in "Uncharted Territory"

Guo Weimin stated that in recent years, China has witnessed a flurry of groundbreaking scientific and technological achievements: "Chang'e" and "Tianwen" missions have ventured into the depths of space, while quantum information and stem-cell research have boldly explored uncharted territories. Meanwhile, cutting-edge technologies like 5G and high-speed railways have significantly enhanced people's daily lives. At the recently concluded Winter Olympics, we showcased numerous high-tech innovations across key areas such as venue construction, event operations, and service delivery. Indeed, China’s scientific and technological advancements have achieved globally recognized milestones.

2022-02-18

Stem cells deliver another breakthrough! The world’s first woman to achieve HIV remission has been born.

On February 15, at the 29th Conference on Retroviruses and Opportunistic Infections (CROI) held in Denver, USA, a research team from Weill Cornell Medicine reported a groundbreaking case: a woman in New York who was living with HIV and acute myeloid leukemia (AML) became the world’s first known woman—and only the third person overall—to achieve HIV remission after receiving a stem cell transplant from a donor naturally resistant to HIV.

2022-02-15

The Winter Olympics are underway! Did you know which athletes have used stem cells to save their careers?

With the rapid advancement of stem cell technology, more and more athletes are turning to stem cell therapy—and are already reaping remarkable results. Let’s take a look at which athletes have used stem cells to salvage their careers.