The State Food and Drug Administration replied to "artificial blood development": It is of great significance, and if it meets the requirements, the review can be accelerated

China News Network, October 26 The website of the State Food and Drug Administration released the "Letter on the Reply to the Proposal No.
4278 (Political and Legal No.
314) of the Fifth Meeting of the 13th National Committee of the Chinese People's Political Consultative Conference" on the 26th, the State Food and Drug Administration said that the development of safe and effective blood substitutes is of great significance for emergency treatment in the case of blood shortage, and if it is assessed to meet the above procedures and standard requirements at the time of declaration, the corresponding accelerated channel
can be applied.

Screenshot of
the NMPA website.

According to the NMPA, in order to support clinical value-oriented drug innovation, the Measures for the Administration of Drug Registration (Order No.
27 of the State Administration for Market Regulation) and the Announcement of the NMPA on the Release of Three Documents including the Working Procedures for the Evaluation of Breakthrough Therapy Drugs (Trial Implementation) (No.
82 of 2020) have established four accelerated channels for breakthrough therapy drug procedures, conditional approval procedures, priority review and approval procedures, and special approval procedures, clarifying the scope of application and encouraging and supporting policies
。 Combined with the rules of product research and development and the needs of applicants, encourage and support policies
such as communication and exchange guidance, rolling submission of materials, and shortening the time limit for review and approval during different periods such as clinical trials, marketing authorization applications and marketing authorization reviews.
For innovative pharmaceutical companies in China in the process of R&D and creation of new drugs, applicants are encouraged to communicate with the drug review center during the research and development period and before application, and those who meet the breakthrough therapy drug procedure and conditional approval procedures can apply
separately.
When applying for marketing authorization, if the applicant is assessed to meet the priority review and approval procedures, it may be included in the priority review and approval procedures to speed up the review and inspection and other work, so as to ensure that the drug is put on the market
as soon as possible.
(End)