The Ministery of Food and Drug Safety will overhaul the approval and review procedures for new drugs, biosimilars, and new-technology medical devices. To shorten approval times, it plans to change review methods and expand staffing.
The Ministery of Food and Drug Safety said on the 11th that it has prepared drafts to establish and revise guidelines related to new drugs, biosimilars, and new-technology medical devices reflecting the "innovative plan for medical product approval and review," and will gather industry opinions through the 20th.
The overhaul follows policy measures to improve bio regulations discussed at the president-led strategic meeting on rationalizing core regulations in Oct. last year.
The core is streamlining approval and review procedures. First, it will introduce a "rolling submission, supplement, and receipt system" that allows data submission and review to proceed in parallel. Previously, reviews began only after all application materials were filed at once, but going forward, sequential review will be possible as materials are ready.
It will also newly provide checklists by approval and review area. The aim is to reduce requests for supplementation by allowing industry to pre-check submission materials.
A "pre-NDA meeting" system, in which the Ministery of Food and Drug Safety and corporations discuss directly before filing, will also be introduced. The idea is to coordinate approval issues in advance during development to reduce review delays.
Along with this institutional overhaul, the Ministery of Food and Drug Safety plans to shorten approval times for products in the new drug and bio sectors by expanding approval and review personnel.