Advanced biologics to receive expedited review

To expand treatment opportunities for rare and intractable diseases

MFDS to expedite the review process for drugs that have improved safety and efficacy over to existing treatments

Advanced biological drugs that have demonstrated a significant improvement in safety or effect compared to existing treatments will be regarded as ‘drugs with no alternatives’ and allowed to receive expedited review in Korea.

 

Until now, only advanced biopharmaceuticals with limited scope of application (such as patients who have positive or negative biomarkers) compared to existing treatments or those for patients who are unresponsive to existing treatments were regarded as ‘drugs with no alternatives.’ However, the Ministry of Food and Drug Safety decided to expand treatment opportunities for patients with rare and incurable diseases by revising the regulations and allowing expedited processing for biopharmaceuticals that have proven improved safety or efficacy compared to existing treatments.

 

On the 7th, the MFDS issued a pre-announcement of administration of the ‘Partial amendment of the marketing authorization and review regulations for advanced biopharmaceuticals' and announced that it will expand patient treatment opportunities and harmonize domestic and foreign standards and regulations.

 

Article 21 of the regulations that will be amended contains the designation of subjects eligible for fast-track review, which includes cases where there are no alternative treatments.

 

Such cases were defined as ▲ cases where there are no domestically approved drugs, and ▲ cases where the target of application is limited due to the existence of positive or negative biomarkers compared to existing treatments, or cases where existing treatments cannot be used.

 

When targeting patients who could not receive it or were unresponsive, it was limited to cases where there were no alternative treatments.

 

However, through the amendment, the government decided to designate advanced biopharmaceuticals that have proven to have significantly improved safety or effectiveness, as well as drugs where production, import, and supply have been suspended and supply has not been resumed, as those subject to fast track review.

 

In addition, probiotics were included in the definition of biological drugs, and the legal basis for restricting marketing authorization for gene therapies was specified as 'Article 11 (1) 9 (c) and (1) of the Rules on the Safety of Drugs, etc.' Also, terms such as quality review and quality evaluation were unified into standards and test method review, and provisions based on submitted data for conditional approval were also revised.

 

The MFDS is accepting opinion submissions about the pre-announced administrative notice until November 6.