China’s National Medical Products Administration (NMPA) proposed rules that would give the regulator a direct role in initiating and overseeing nationally funded R&D projects spanning pharmaceuticals, medical devices and cosmetics.
The draft rules, released August 13 for comment through September 12, give the NMPA responsibility for proposing special projects under China’s National Key R&D Program, drawing up implementation plans and funding estimates, issuing annual project calls and overseeing their execution and evaluation.
NMPA-affiliated institutions have previously led regulatory science research under National Key R&D Program special projects administered by other authorities, while the regulator has worked to incorporate regulatory science priorities into national R&D programs. The new framework applies specifically to projects for which the NMPA itself serves as the lead responsible authority (主责单位).
NMPA has not disclosed which special projects it plans to lead, their research priorities or potential funding. Those details would be set out in subsequent project implementation plans and annual application guidelines.
What it covers
The nine-chapter draft establishes the governance framework for NMPA-led special projects across their full lifecycle, from project initiation and application through review, implementation and final evaluation. NMPA would retain authority over project approval, major adjustments and overall performance assessment, while delegating day-to-day administration to accredited professional management agencies.
The framework also sets requirements covering research integrity and ethics, funding management and intellectual property. Projects involving life sciences, medicine and artificial intelligence would be subject to ethics oversight, while research misconduct could result in sanctions. Intellectual property generated through funded projects would generally be governed by existing national laws, with the state retaining certain rights where national security or significant public interests are involved.
Industry to play prominent role
The proposed framework points to an industry-facing remit extending beyond regulatory science. NMPA-led projects may address major scientific questions, key common technologies and product R&D affecting the pharmaceutical sector’s core competitiveness and indigenous innovation capabilities, covering drugs, medical devices and cosmetics.
The rules call for enterprises to play a central role in technological innovation and require projects to emphasize practical outcomes and the conversion of research results into productive capacity and industrial competitiveness.