Companies can apply for multiple clinical protocols at once

to accelerate global entry of Korean pharmaceutical companies

MFDS completes preparing procedures as a follow-up to Regulatory Innovation 3.0

Pharmaceutical companies can now apply for multiple clinical trial at the same time for a single investigational drug that is being approved for the first time.

 

The measure is presumed to have been implemented to accelerate global entry of domestic pharmaceutical companies.

 

The Ministry of Food and Drug Safety has upgraded its computer system that manages same-ingredient investigational drugs to allow companies to apply for multiple clinical trial protocols at the same time.

 

According to the pharmaceutical industry on the 23rd, the MFDS has prepared a follow-up measure to the 16th Task of the 'Food and Drug Regulatory Innovation 3.0' plan it had announced on May 2nd.

 

Until now, every investigational new drugs was managed under one approval number for systematic management and to facilitate batch changes of quality data, so companies had to receive approval for one initial clinical trial protocol, then additionally apply for changes to add protocols.

 

However, there has been industry opinion that it is difficult to conduct clinical trials swiftly in Korea during multinational clinical trials, as the company is required to add a protocol again if it seeks to target a different disease after receiving approval for the first protocol.

 

Regarding this, MFDS Director Kyung-Seung Shin, Director of the Clinical Trials Policy Division at MFDS said, "In the case of clinical trials, multiple protocols are submitted for a single drug candidate to test it on multiple diseases, and the successful outcome of some of the trials lead to the drug’s final approval.” Shin explained, "It has been pointed out that the formulation, content, and route of administration cannot be clearly specified because the MFDS manages each drug candidate under one approval number.

 

From now on, it will be possible to apply for a single clinical trial that contains various trial protocols at once for a same-ingredient drug” The MFDS expects the simultaneous application for clinical trials for a same-ingredient drug to accelerate the domestic industry's initiation of global clinical trials.

 

However, even though companies can apply for multiple protocols of a first-approved investigational new drug at the same time, companies would need to submit the data and fees for each protocol approval application separately.

 

However, for quality changes, the company would need to separately apply for approval of the change in each protocol.

 

This means that quality changes cannot be applied unilaterally to all trial protocols.

 

Also, companies can apply for additional protocols (modifications) after receiving initial protocol approval as in the past.