Drugs subject to 2nd evaluations may submit data by Oct

to meet standard requirements and preserve current listed price

Period was extended in consideration of inevitable circumstances as for the drugs that received 1st evaluations

The changes were briefed to companies on the 10th... drugs that did not select reference drugs, etc. will be able to earn time to conduct bioequivalence tests and generate required data

Drugs that were to receive the 2nd series of reevaluations by HIRA and were required to submit data by July will also be deemed to have met their requirements even if they exceed their submission deadline and submit the Ministry of Food and Drug Safety review completion notice by the end of the objection period.

 

This will allow companies an additional 3 months of time, until October, to submit data.

 

The measure has been made in consideration of the unavoidable circumstances, just as the first series of drugs that were subject to receive evaluations this year.

 

According to the Health Insurance Review and Assessment Service on the 7th, oral and sterile preparations that were subject to receive evaluations in the second review were required to submit data by July 31 will be deemed to have satisfied their requirements if they submit their MFDS review completion notice within the objection period in consideration of the delay in MFDS review.

 

A total of 5,905 oral and sterile preparations that were expanded and designated to conduct bioequivalence tests were set to receive the second set of evaluations.

 

Some of the items have not even started bioequivalence tests , being unable to designate reference drugs.

 

The authorities had previously announced that it will register priority review requests from drugs subject to receive the first set of evaluations and need to submit their data by February, and deem those companies that submit MFDS review completion notice within the objection period to have satisfied standard requirements.

 

Therefore, relevant companies will first submit review requests to the MFDS by February, then submit their review completion notice by May.

 

The data submission deadline had been extended in consideration of the COVID-19 situation, and HIRA explained that the same consideration will be provided to drugs subject to the second series of evaluations.

 

Therefore, drugs subject to receive the second series of evaluations will be allowed to first submit review requests by July and submit the review completion notice by October to satisfy the standard requirements.

 

HIRA believes that the 3-month addition to the deadline of the drugs subject to receive the second series of evaluations will allow drugs whose bioequivalence tests have been delayed due to reasons including non-announcement of reference drugs or difference in the sorbitol additive with its reference drug, to fully conduct reevaluations.

 

A HIRA official explained, “Although discussions will still need to be made with the MFDS, we believe most drugs will be able to submit data within the evaluation period." Meanwhile, HIRA will hold a briefing session on its reevaluation of standard requirements on reimbursed ceiling price of listed drugs at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association office from 3:30 p.m.

 

on the 10th and provide guidance on frequently asked questions in a Q&A format.

 

Afterward, after collecting the opinions of the pharmaceutical industry on the series of evaluation subjects that will follow, the final list of drugs subject to evaluation will be released on HIRA’s webpage once again.