Scientific innovation supervision "can have both fish and bear's paws"

On October 15, at the launching ceremony of the “National Safe Drug Use Month” in 2021, Qin Xiaoao, Director of the Department of Science and Technology and International Cooperation of the State Food and Drug Administration, stated that breakthroughs have been made in the implementation of the Regulatory Science Action Plan for more than two years.

Significantly shortened approval time

"Time is life", and faster approval means that innovative drugs can enter the market earlier to cure patients

The shortening of the approval time of the world's six major approval agencies is due to the use of the "Fast Track (FRP)" by various agencies

Table 1 Various types of "rapid approvals" by the six major regulatory agencies in 2020.

Figure 1 The use of "accelerated approval" channels by major institutions in 2020

Data source: Centrefor Innovation in Regulatory Science

Synergistically accelerate the launch of new drugs

The Access Consortium (Access Consortium) formed by the United Kingdom, Canada, Australia, Singapore, and Switzerland aims to promote more regulatory cooperation, maximize international cooperation and form unified regulatory requirements, reduce repeated approvals, and improve innovative drug Patient accessibility

In addition to the approval alliance, the Orbis program initiated by the U.

Escorting decision-making

New drug approval needs to balance the efficacy and risks, and use real-world data and pharmacovigilance to escort decision-making

The European Medicines Agency (EMA) launched a pilot project in 2014 to explore the feasibility of using real-world data for regulatory decision-making, and established a big data working group in 2017 to use big data to improve supervision Make decisions and improve the standard of evidence

In terms of pharmacovigilance, Chapter 21 of the CFR of the United States Code of Federal Regulations stipulates the construction of pharmacovigilance system, signal management and other aspects, and has issued nearly 30 guidelines on post-marketing drug safety

(Part of the content is selected from the "2021 China Innovative Drug Blue Book")