The Ministery of Food and Drug Safety will ease regulations so that for minor changes, such as changes in the location of pharmaceutical manufacturers and importers due to administrative district reorganizations, companies can simply file a report without going through existing approval or notification procedures.
The Ministery of Food and Drug Safety said on the 21st that it gave advance notice of legislation for a revision to the Rules on the Safety of Drugs, etc., and will accept opinions through Oct. 21.
Key points include: ▲ switching to reporting for minor changes such as location changes due to administrative district reorganizations ▲ shortening the processing period for clinical trial plan approvals ▲ shortening the submission deadline for drug recall plans ▲ international harmonization of good manufacturing practice (GMP) for investigational drugs.
First, for changes such as location changes due to administrative district reorganizations affecting pharmaceutical manufacturing, import, and contract manufacturing and sales businesses, as well as clinical trial plans, clinical trial sample analysis institutions, and nonclinical testing institutions, procedures will be simplified so that companies need only report within one year instead of obtaining change approval, notification, authorization, or designation.
Approval for clinical trial plans (and amendments) will also be improved so that, if the preliminary review results are appropriate, the statutory processing period can be shortened. This is part of the "60 tasks for food and drug safety assurance," prepared to ease inconveniences in daily life and support the growth of new industries such as AI and biotech.
If safety or efficacy issues arise with drugs in distribution, requiring a recall, the submission deadline for the recall plan will be shortened from the current five days to three days. The measure is intended to respond quickly to recalls and enhance the safety of products in distribution.
Good manufacturing practice (GMP) standards that must be followed when making investigational drugs will also be revised to meet international standards. The changes of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which sets international good manufacturing practice standards for drugs, will be reflected.
The Ministery of Food and Drug Safety said it expects the revision to lay the groundwork for easing the regulatory burden on the pharmaceutical industry while strengthening drug quality and safety management.