The Ministery of Food and Drug Safety will include biosimilars (biosimilar) in the fast-track review. As a result, the review period will be shortened from 406 days to 295 days.
The Ministery of Food and Drug Safety said on Apr. 6 that it will revise and implement the Regulations on marketing authorization and review of biological products to reflect this. This revision is a follow-up measure after the biosimilar approval period was shortened this year. By newly including biosimilars in the fast-track review, the agency established an administrative basis to enable faster approvals.
The system for managing changes to manufacturing methods was also adjusted. Easing the requirement that changes to manufacturing methods for biological products be made only through the change-approval process, the agency will allow changes through premarket reporting or postmarket reporting when the impact on quality is minor. The aim is to reduce the burden on corporations and to build a swift change-management system.
An official at the Ministery of Food and Drug Safety said, "This revision supports the development of the biopharmaceutical industry while also rationally improving the authorization and review system," and added, "We plan to continue strengthening administrative support and steadily improving related systems going forward."