미국과 EU의 의약품 신속 개발 및 허가 프로그램의 동향과 쟁점

Expedited Drug Development and Approval Programs of the US and EU:

This study investigated the expedited drug development and approval programs of the US and EU, programs which intend to foster innovation and early access to new medicines addressing unmet health needs. I categorized the expedited programs into three types based on their distinctive features: shortening review time to advance the release date; approving drug based on the surrogate outcome imposing the responsibility of post-market confirmatory trials on the company;providing intensive guidance and close interaction with the company for successful development of new drug. Although those expedited programs have reduced drug development time and contributed to early access to medicines of patients, it is uncertain whether they have also facilitated innovation. Approvals based on the surrogate outcome raise concerns over insufficient evidence and safety issues. Studies have different results on whether safety-related warnings or withdrawals have increased after the introduction of expedited programs. Expedited programs have been criticized with regard to the post-market study obligation, obligation which is often neither fulfilled well nor supervised rigorously. Only implementing expedited program does not assure innovative development of medicines. Achievement of the goals will depend on the details of program-relevance of qualifying criteria, thorough supervision of confirmatory studies, transparency in evidence development.