The global regulatory system for innovative drugs is undergoing profound changes. Under the ICH framework, China has moved beyond alignment and implementation of guidelines to deep engagement and joint development. China Pharmaceutical Innovation and Research Development Association(PhIRDA) has long been committed to advancing global regulatory harmonization. PhIRDA has nominated Chinese experts to join the International Federation of Pharmaceutical Manufacturers and Associations(IFPMA) ICH Task Forces. This enables China to take a greater part in participating in international pharmaceutical regulations, improving R&D efficiency, enhancing regulatory science, facilitating mutual recognition of quality standards, and supporting the global development of innovative medicines.

I. Focus on Cutting-edge Topics, Engage Early and In-depth in Formulating New Guidelines

In recent years, approvals for rare diseases contribute an increasing and sustained proportion of new active substances. Because clinical trials in rare disease drug development are often multinational and with small or very small populations, it becomes imperative to maximize the use of reliable and high-quality real-world data, such as natural history studies, to design and conduct informed trials that may be the only opportunity for both patients and developers to reliably demonstrate the safety and efficacy of an investigative product. Against this backdrop, a new topic ICH E24: Natural History Studies and Registry Data to Advance Rare Disease Drug Development was endorsed by the Assembly at the ICH Madrid Meeting. This guideline will address high level principles and practical guidance on how to initiate natural history studies and registries to generate data, that can fully utilize in rare disease drug development R&D. PhIRDA has successfully nominated five experts to join the IFPMA ICH E24 Task Force. Experts will take an active part in the drafting and formulation of this guideline and promote the harmonization of relevant international regulations.

II. Strengthen Regulatory-Industry Collaboration, Promote Global Data Sharing

As a highly specific standardized medical terminology, MedDRA is used for registration, documentation and safety monitoring of medical products before and after a product was authorised for sale and serves as a fundamental pillar for international regulatory data exchange, risk assessment and scientific evaluation. During the ICH Madrid Meeting in May 2025, the National Medical Products Administration of China has been appointed by the ICH MC to join the MedDRA Steering Committee. This enables China to directly participate in the operation and governance of this core medical standard at the national level and advance international data sharing and collaboration.

Dr. Meng Yuan, Chief Medical Officer and R&D Head at TJ Biopharma, one of PhIRDA’s member organizations, was selected via internal review by IFPMA to serve as a representative of the MedDRA Task Force. He, together with Dr. Guo Xiaojun, Vice President, Drug Safety and Pharmacovigilance of HutchMed, will directly engage in the global governance of MedDRA. Both experts also attended the recent ICH Meeting held in Brazil. This milestone demonstrates that regulatory-industry collaboration has extended to all aspects of relevant governance work across multiple dimensions. Chinese industry will share practical experience and insights to improve the scientific soundness and efficiency of global regulatory data sharing.

III. Data Structuring, Reshaping the Global Regulatory Submission System

Driven by the advancement of global harmonization for pharmaceutical registration standards, ICH M4Q(R2): Common Technical Document on Quality has become the core standard for pharmaceutical registration submissions, particularly for international registration. On 13 February 2026, ICH released the M4Q(R2) Mock-ups, which bring major innovations to the structure and content of the Technical Document on Quality. Recently, the Center for Drug Evaluation(CDE) launched a public consultation on the eCTD v4.0 Guideline. The transition from traditional CTD to eCTD represents a comprehensive upgrade of technical specifications and workflow paradigms for pharmaceutical registration.

PhIRDA has recently nominated seven experts to join the IFPMA ICH M4Q(R2) and M8 Task Forces, which will further integrate China’s drug submission and review system into the global framework, and promote China’s pharmaceutical registration into a new era featuring refinement, standardization and internationalization.

As of June 2026, PhIRDA has nominated 83 experts (including 13 Leads and 12 Alternates) to 35 IFPMA ICH Task Forces, accounting for 43% of IFPMA’s global expert pool.

During May 30 to June 3, the ICH Meeting was held in Rio de Janeiro, Brazil. Four Task Force leads from PhIRDA attended the meeting upon invitation, fully demonstrating the professional influence of Chinese industry experts within the global regulatory science system. They have contributed Chinese expertise and industry insights to enhance the scientific rigor, practicality and global applicability of international standards.

Click to view PhIRDA IFPMA ICH Expert List