Korea's Drug Agency Shortens New Drug Approval Process to 10 Days

The Korea Drug Agency (KFDA) is set to ease administrative burdens on the pharmaceutical industry by changing the approval process for minor modifications to a reporting system. The approval processing time for clinical trial plans that pass preliminary review will also be reduced by up to one-third.

On August 21, the KFDA announced a legislative notice for amendments to the 'Regulations on the Safety of Medicines and Related Products,' inviting public comments until October 21.

The key focus of the amendments is to streamline the handling of minor changes due to administrative district reorganizations. Previously, if the location of a drug manufacturing, import, or contract manufacturing company changed due to such reorganizations, a modification approval or notification was required. Under the new rules, companies will only need to report these changes within a year. Similarly, changes in the location of clinical trial plans due to administrative district changes will now be handled as reports instead of requiring modification approval. Changes in the locations and representatives of clinical trial specimen analysis institutions and non-clinical trial conducting institutions will also shift from modification designation to reporting.

A significant change that the pharmaceutical industry will notice is the reduction in the approval time for clinical trial plans. Currently, the approval process for clinical trial plans and modifications takes 30 days, regardless of the preliminary review results. After the amendments, if the preliminary review confirms suitability, the processing time will be cut to 10 days. This change is part of the KFDA's '60 Key Tasks for Food and Drug Safety,' aimed at accelerating the clinical entry of new drug development companies.

While simplifying procedures, the KFDA plans to strengthen drug safety management. In cases where safety or efficacy issues arise with domestically distributed medicines, the deadline for the responsible party to submit a recall plan will be shortened from the current five days to three days. Additionally, actions that mislead consumers into thinking they are being directly advertised by professionals, such as doctors, using artificial intelligence (AI) will be prohibited. The manufacturing and quality management standards for clinical trial medicines will be aligned with international standards by reflecting the revised guidelines of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

The KFDA expects that these amendments will alleviate unnecessary regulations and administrative burdens on the pharmaceutical industry while enhancing the quality and safety management of medicines.