DIA Global Annual Meeting China Session: Regulatory reform and clinical capabilities are two-wheel drive, and China’s pharmaceutical innovation is ushering in new global opportunities
On the afternoon of June 16, 2026, Eastern Time, the "China Special" was successfully held at the 2026DIA Global Annual Meeting. The venue was packed with nearly 200 representatives of pharmaceutical companies, regulators and investors gathered to pay attention to the latest changes in China's pharmaceutical industry.
The meeting was chaired by Dr. Su Ling, a global fellow of DIA.
First, Ms. Shi Hui, head of the Development and Research Office of China Food and Drug International Exchange Center, gave a detailed introduction to the National Medical Products Administration (NMPA)’s international exchange and cooperation initiatives in the field of drug supervision. She introduced that China is actively integrating into the global drug regulatory system through multi-level and multi-dimensional international cooperation and promoting institutional openness to create a more open and efficient development environment for global pharmaceutical companies.
- The global regulatory cooperation network continues to expand
Shi Hui said that NMPA continues to expand cooperation with drug regulatory agencies in countries along the “Belt and Road” and BRICS countries, and has strengthened communication and exchanges in regulatory policy coordination, docking of laws and regulations, capacity building, mutual recognition of market access standards and post-marketing supervision. At the same time, China has long maintained effective communication with the World Health Organization (WHO), actively participated in global drug governance, and has been elected as a member of the Management Committee of the International Council for Coordination of Technical Requirements for Pharmaceuticals for Human Use (ICH) for three consecutive terms. At present, China has fully adopted and implemented all ICH guiding principles and is actively promoting its participation in the International Pharmaceutical Inspection Cooperation Scheme (PICS) in order to integrate with international standards at a higher level. In addition, in the field of traditional Chinese medicine, NMPA actively promotes the international harmonization of pharmacopoeia standards for Chinese medicinal materials, and took the lead in establishing the Western Pacific Herbal Medicine Coordination Forum to promote the global integrated development of traditional medicine.
Shi Hui introduced that NMPA has proposed a series of new institutional opening measures aimed at further enhancing regulatory transparency and international participation. Specific measures include: comprehensively supporting international multi-center clinical trials (MRCT), optimizing the review and approval procedures for overseas new drugs, and exploring pilot cross-border segmented production of biological products. These measures will not only shorten the launch cycle of innovative drugs in China, but also provide multinational companies with more flexible production and supply chain layout options.
Shi Hui, Head of Development Research Division, China Food and Drug International Exchange Center
Subsequently, Ms. Zhou Huijuan from the Exchange Office of China Food and Drug International Exchange Center shared the progress of China's drug regulatory reform. In recent years, China has continued to promote the integration of the drug regulatory system with international standards through measures such as improving laws and regulations, optimizing the review and approval process, and strengthening technical guidance, and the results of the reform have gradually emerged.
On May 15, 2026, the newly revised "Implementation Regulations of the Drug Administration Law" were officially implemented, clearly supporting clinical value-oriented drug research and development, optimizing the drug registration review and approval process, establishing accelerated procedures for drug marketing registration, and clarifying drug re-registration procedures; granting a market exclusivity period to qualified children's drugs and drugs for the treatment of rare diseases, and providing data protection for drugs containing new chemical ingredients. In March 2025, the "Pharmacopoeia of the People's Republic of China" (2025 Edition) was released and officially implemented in October. It proposed more standardized technical requirements for pharmaceutical preparations, production processes and registration applications, providing a solid guarantee for drug quality.
In terms of reform of the review and approval system, in September 2025, the National Medical Products Administration (NMPA) launched a 30-day clinical trial review and approval channel for some categories of innovative drugs based on the original 60-day implicit approval, which significantly shortened the waiting time for innovative drugs to enter the clinical stage. At the same time, a total of 49 technical guiding principles were released throughout 2025, focusing on areas such as cutting-edge technology, major diseases, and medication for special populations. To date, a total of more than 600 guiding principles have been released, providing systematic guidance for industry research and development.
NMPA actively promotes the implementation of a number of reform results, including optimizing the review and approval pilot projects for clinical trials of innovative drugs, optimizing the review and approval procedures for drug supplement applications, and segmented production of biological products, and comprehensively deepens the implementation of various measures for drug regulatory reform. In order to speed up the launch of innovative drugs, NMPA encourages companies to strengthen research and development, and adopt precise service measures such as "early intervention, one company, one policy, full guidance, and research and review linkage" for key varieties, which has effectively improved the quality and efficiency of research and development. A total of 76 innovative drugs will be approved for marketing in 2025, fully reflecting the dividends of reform.
Looking forward to the future, Zhou Huijuan said that NMPA will continue to improve the drug laws and regulations system, enhance regulatory capabilities, and promote the construction of smart supervision; at the same time, it will further accelerate integration with international practices, promote simultaneous R&D applications for overseas new drugs, actively participate in global drug governance, and contribute China's strength to building a human health community.
Zhou Huijuan Exchange Office, China Food and Drug International Exchange Center
Professor Chen Xiaoyuan from Tsinghua University School of Medicine systematically sorted out the "evolution" of China's clinical trial landscape from 2015 to 2025. She pointed out that the past decade was a critical period for China's clinical research to achieve leapfrog development, with significant breakthroughs made in terms of quantity, resource capacity, and policy environment.
Data shared by Professor Chen Xiaoyuan shows that the number of clinical trials in China has continued to grow over the past decade. In 2025, the number of clinical trials in China will account for 50% of the global total, showing strong growth momentum. Judging from the composition of sponsors, nearly 90% of clinical trials initiated by Chinese companies were conducted in mainland China, showing the continued release of local innovation vitality; while the proportion of international multi-center clinical trials (MRCT) conducted by foreign-funded companies in China has increased significantly, jumping from 2% in 2015 to 11% in 2025, confirming the dual enhancement of China's participation and attractiveness in the international multi-center trial system.
In terms of clinical resources, the number of registered institutions has steadily increased, forming a multi-level pattern with traditional centers such as Beijing, Shanghai, and Guangdong taking the lead, and emerging centers such as Chengdu, Wuhan, and Shenzhen accelerating their rise. The team of principal investigators (PI) has grown rapidly, but the top 50 senior researchers still bear a larger proportion of experimental tasks, reflecting the concentration of high-level talent resources. In terms of clinical trial efficiency indicators, the start-up time of both tumor and non-tumor clinical trial projects has been greatly shortened, and the efficiency of phase I trials is particularly outstanding. The recruitment efficiency of phase I trials of oncology drugs in China is 1.0 (number of patients/center/month), while the global rate is 0.3 (number of patients/center/month).
Professor Chen Xiaoyuan also introduced the important measures related to clinical trials recently launched in China. In terms of review and approval, the new policy further reduces the review time for clinical trial applications to 30 days for certain categories of innovative drugs and MRCT projects led by Chinese researchers, significantly improving the efficiency of R&D startup. In terms of management paths, my country has formed three parallel clinical trial development models: the traditional IND registration path, the researcher-initiated post-marketing research path (IIT), and the biotech path established in accordance with Document No. 818. The three paths are mutually systematic and aim to promote high-quality clinical research and innovative development.
Professor Chen Xiaoyuan finally said that the evolution of China's clinical trial landscape in the past decade is not only the result of regulatory reform and industrial investment, but also indicates that China will play a more important hub role in the global innovative drug research and development network in the future. With the continuous optimization of review efficiency and the continuous improvement of clinical capabilities, China is expected to bring more high-quality clinical research data and innovative treatments to patients around the world.
Chen Xiaoyuan Professor at Tsinghua University
In the expert discussion session of this special meeting, Dr. Zhang Wei, Senior Vice President of Boehringer Ingelheim and Head of Greater China R&D and Medical Department, and Dr. Wang Qinghua, Founder, Chairman and CEO of Guangzhou Innogen Pharmaceutical Group Co., Ltd., shared their wonderful insights on the strategic direction of enterprises in the new environment from the perspectives of multinational enterprises and local Chinese bio-innovation enterprises respectively, providing participants with diversified industry thinking.
Dr. Zhang Wei pointed out that in the face of increasingly fierce global competition, companies must put innovation at the core, dare to get involved in new treatment modalities and innovative practices, and demonstrate competitiveness on the global stage. He emphasized that while Chinese local companies are actively expanding overseas markets, they also need to carefully balance the relationship between "going global" and deeply exploring the Chinese market and achieving local business success. In addition, he suggested that the government further strengthen its support for "thesis innovation", that is, encouraging basic research and early proof of concept to help companies obtain more key resources and lay the foundation for long-term development.
Dr. Wang Qinghua started from local innovation practices and proposed that innovation should start from the real needs of patients, especially in the field of chronic diseases such as metabolic diseases, and is committed to providing effective, safe, convenient and affordable long-term health service solutions. He particularly emphasized that Chinese companies should standardize on global technical standards from the beginning, independently establish complete clinical research, CMC (chemistry, manufacturing and control), QA (quality assurance) and TV (treatment verification) systems, and drive research and development with clear clinical evidence and value. In terms of globalization, Dr. Wang Qinghua suggested conducting international clinical trials in emerging markets. This will not only help verify the global applicability of China's local clinical data, but is also an effective way to expand overseas markets and enhance international competitiveness.
Participants said that China is no longer just a market, but also a player in rules and a benchmark for efficiency. The speed of regulatory integration with international standards, the maturity of clinical resources, and the tolerance of policies for innovation are all providing new windows of opportunity for global pharmaceutical companies. More and more overseas innovative pharmaceutical companies are paying great attention to China's development, especially early clinical investment. The person in charge of an overseas startup company expressed on the spot that he hopes to set up his company in China to speed up the clinical development of projects.
From left: Zhou Huijuan, Wang Qinghua, Zhang Wei, Su Ling, Chen Xiaoyuan, Shi Hui
During this DIA Global Annual Meeting, the US FDA, EU EMA, UK MHRA, Health Canada and Brazil ANVISA held special drug supervision sessions respectively, as well as special sessions for Japan, the Middle East, Indonesia, India and other countries.
Source of article: Shanghai Representative Office of International Pharmaceutical Information Association