China’s National Medical Products Administration (NMPA) has released a draft proposal titled “Opinions on Reforming and Improving the Administration of Review and Approval of Radiopharmaceuticals,” seeking public feedback. The document outlines a series of reforms aimed at enhancing the regulatory framework for radiopharmaceuticals in the country.
Expanding Expertise in Radiopharmaceutical Review
The draft proposal suggests expanding the team of experts involved in the review of radioactive drugs. It emphasizes the importance of leveraging expert input in policy formulation, the development and revision of guidelines, and technical reviews of drugs. This move aims to strengthen the scientific basis of regulatory decisions and improve the overall efficiency of the review process.
Encouraging Innovation and Prioritizing Review
The document encourages innovation in radiopharmaceuticals with a focus on clinical value. It proposes prioritizing the review and approval of filings for radiopharmaceuticals, establishing a long-term mechanism for early intervention, continuous tracking, and active service. Enhanced communication and guidance throughout the R&D and regulatory filing process are also highlighted as key measures to support the development of these critical medicines.
Improving Technical Review Systems
The draft outlines the need to improve the technical review system for radioactive drugs to better reflect their unique characteristics. This includes refining acceptance criteria, technical reviews, verification, and inspection processes. The document also calls for the study and improvement of management and classification of radioactive particles, microspheres, radioimmunoassay kits, and other related products. Additionally, it suggests enhancing the filing pathways and data requirements for nuclides, generators, and cold kits by referencing international experience and aligning with China’s regulatory reality.
Strengthening Regulatory Capacity
The document proposes strengthening the technical evaluation system for radioactive drugs and enhancing the capacity for inspection and testing. It also calls for increased supervision of production and distribution, as well as the promotion of revisions to relevant laws and regulations. These measures aim to ensure the safety, efficacy, and quality of radiopharmaceuticals throughout their lifecycle.-Fineline Info & Tech
