China: NMPA to review supervision of cell and gene therapies through regulatory action plan

08-05-2019

China: NMPA to review supervision of cell and gene therapies through regulatory action plan

(Source: RAPS 2019-05-09)

China’s National Medical Products Administration (NMPA) has put oversight of cell and gene therapies at the center of its drug regulatory science action plan. NMPA has adopted the plan to foster development of new regulatory tools, systems and processes and drive scientific projects.

The first batch of action plan projects picked by NMPA include the aforementioned effort to improve the technical evaluation and supervision of cell and gene therapies, plus initiatives focused on the safety and quality of nano drugs and the clinical assessment of traditional Chinese medicines. NMPA will add more projects to the action plan in the future.

Universities and scientific research institutions will support the action plan by carrying out some of the assessments and helping to develop new tools, standards and methods. NMPA also hopes the initiative will promote the advancement of regulatory science and training of people in the field.

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