Pilot Drug Approval·Review Coordination Committee extended

by one year

Operation will continue through August 28 of next year…after that date, a review will take place to transition the committee into a full-scale project

The pilot operation period for the Pharmaceutical Approval and Review Coordination Committee will be extended by one year.

 

According to the pharmaceutical industry on September 3, the Ministry of Food and Drug Safety (MFDS) decided to extend the pilot period for the Coordination Committee by one year, starting from August 29.

 

The committee had been operating on a trial basis for one year since June 17 of the previous year.

 

This extension is based on a revision of the committee's operational guidelines.

 

For the past year, applications for adjustment were limited to cases involving safety and efficacy review data, quality review data, and documentation related to data protection.

 

However, starting this year, the scope has been expanded to include 'all matters' for which the Pharmaceutical Approval Management Division has requested supplementary data.

 

The scope of applications for adjustment following the Pharmaceutical Approval and Review Coordination Committee extension.

The Coordination Committee was established last June to make the drug product approval and review process more transparent and rational.

 

It allows applicants to request an adjustment when supplementary data is asked for during the drug product approval and review process.

 

The committee, chaired by the Director of the Drug Safety Bureau, includes the Head of the Pharmaceutical Review Department, the Director of the Pharmaceutical Policy Division, the Director of the Pharmaceutical Approval Management Division, relevant review department heads, and experts from the Central Pharmaceutical Affairs Council.

 

They proceed with adjustments through a majority vote.

 

With the pilot program extended for another year, it will apply to applications submitted to the Pharmaceutical Approval Management Division.

 

The MFDS plans to evaluate the operational results at the end of this period to decide whether to terminate the pilot program, transition it to a full-scale operation, or further expand the scope of adjustment applications.

 

The scope of applications for adjustment includes ▲Review data specified in Article 5 of the 'Regulations on Drug Product Approval, Notification, and Review' ▲Data related to the eligibility for clinical trial data protection, as per Article 31-6 of the 'Pharmaceutical Affairs Act' and Article 21-2 of the 'Rules on the Safety of Pharmaceuticals, etc.' ▲Other matters for which adjustment is deemed necessary in response to a request for supplementary information (excluding requests for supplementary data needed for evaluating the implementation status of Good Manufacturing Practice (GMP) and clinical trials).

 

An applicant wishing to request an adjustment must submit an application form, as specified in Annex No.

 

1 of the guidelines, to the Pharmaceutical Approval Management Division within 30 days of the request for supplementary information.

 

The committee plans to process the adjustment applications, in principle, within the 60-day supplementary request period.

 

Only the applicant listed on the application form can request an adjustment; an agent cannot make this request.

 

Meanwhile, once an application is selected for adjustment, it will be thoroughly discussed at a Coordination Committee meeting, which is composed of both internal and external experts.

 

A two-thirds majority vote of the committee members present decides on the supplementary requirements.

 

The results of the adjustment are then communicated to the relevant divisions and the applicant.