The status of clinical trials is reported annually

for conditional approval drugs

Priority review targets such as drugs for severe and rare diseases are permitted within 40 days

The MFDS announced the legislation of partial amendments to related rules

The subject of conditional approval and Priority review will be more clarified, and follow-up management will be strengthened.

 

Previously, conditional approval regulations were in the notice, but it is expected that management and operation will be strengthened, including related contents in the Pharmaceutical Affairs Act, and procedural justification will be secured.

 

The MFDS announced on the 19th that it had announced some amendments to the rules on drug safety.

 

The revision was prepared to stipulate detailed standards for matters delegated by the revised Pharmaceutical Affairs Act on July 20.

 

The revised bill included ▲simplification of the sample collection procedure for drugs approved for shipment to the state in the event of a public health crisis,▲ regulations on the subject and procedure of conditional permission and priority examination, ▲ regulations on the subject and procedure of disclosure of the results of item permission and report examination, ▲adding the scope of raw materials and drugs subject to registration with overseas manufacturing companies, ▲ exemption from separate designation procedures for performing sample analysis work at a medical institution designated as a clinical trial institution, and ▲ the deletion of some exemption criteria for labeling and description of non-drugs such as sanitary pads and masks.

 

Conditional approval and priority review targets are defined as treatments for severe diseases and rare drugs.

 

▲Those who have obtained conditional permission report the clinical trial status by the end of March every year, and submit a report on the clinical trial results after the clinical trial is completed.

 

▲Drugs subject to the Priority Review will be reviewed within 40 days.

 

The subject of disclosure of the results of the product license and report review was defined as finished drugs, and the results of the review were disclosed within 180 days from the date of product license and report with the opinion of the product licensee.

 

The revision included medical institutions designated as clinical trial institutions so that they can perform related tasks even if they are not designated as clinical trial sample analysis institutions.

 

Currently, sanitary pads and masks were exempted from labeling such as efficacy, effectiveness, dosage, and consignment manufacturers, but in the future, they will be listed the same as other pharmaceutical products.

 

National lot release-targeted drugs, such as biological agents, should be collected by MFDS officials and sealed the number of lot release applications, but companies will be able to collect samples needed for testing and submit them to the Minister of Food and Drug Safety.

 

The MFDS said it expects the preparation of detailed regulations on conditional approval and priority review to help expand patient treatment opportunities and quickly supply medicines, and that it will actively review and improve the drug safety management system.

 

Organizations or individuals with opinions on this amendment can submit their opinions to the MFDS or the National Participation Legislative Center by December 20, 2021.

 

For more information on the amendment, visit Korea Ministry of Government Legislation (opnion.lawmaking.go.kr) or It can be found in the MFDS (mfds.go.kr) → statutes and data → legislative/administrative notices.