Bioequivalence reevaluation may hinder drug license renewal

MOHW plans to revive bioequivalence reevaluation and tighten renewal review

Drug industry “Needs consistent review approach with detailed standards”

Korean pharmaceutical industry is voicing their concerns about the Ministry of Food and Drug Safety’s (MFDS) plan to revive bioequivalence reevaluation and to toughen the item license renewal review procedure.

 

Arguing the government’s redundant review could harm them, the industry claims the ministry should set down more consistent review approach to avoid having a series of contradicting review results.

 

The industry sources reported on Mar.

 

31, MFDS has unveiled the first Master Plan for Pharmaceutical Safety Management (valid from 2020 to 2024) containing details of reviving bioequivalence reevaluation and strengthening license renewal review.

 

The ministry means to enhance credibility of approved drug quality through strenghtened bioequivalence test system for prescription drugs.

 

Basically, the ministry is bringing back the regular bioequivalence reevaluation that was removed in 2018 due to the newly implemented renewal system.

 

MFDS would finalize a master plan for bioequivalence reevaluation by 2024, after compiling a list of reevaluation subjects within this year.

 

Some of the pharmaceutical industry agrees that bioequivalence reevaluation on already-approved items would be unavoidable due to the expanded bioequivalence test policy.

 

Oral drugs would be required submit bioequivalence test results from this year, injection and sterile medicinal products from 2021, and all drugs from 2022.

 

Already-approved drugs without qualifying bioequivalence test result would need to submit the test result to maintain their original pricing.

 

However, the industry points out reviving the bioequivalence reevaluation, after the government has replaced the old reevaluation procedure with the current renewal system, would become a redundant procedure.

 

An insider in government affairs explained, “An item approved through bioequivalence reevaluation could fail to renew and lose its license, because it was not listed in a foreign pharmacopoeia.” At the movement, the item renewal review prioritizes listing on an overseas pharmacopoeia.

 

Apparently, some drugs have had their license revoked unfairly, only because they were not listed on overseas pharmacopoeia.

 

Pharmaceutical industry expert groups argue the renewal review should have its own review standards, instead of relying on pharmaceutical status in other countries.

 

Another government affairs associate criticized, “The Korean government should step away from outdated style of depending on certificate of pharmaceutical product (CPP) issued by an advanced country, but rather it should set forth an independent review standards,” and “the safety management master plan does specify its objective, but it is missing detailed standards.” Seemingly conscious of these criticisms, MFDS has announced the license renewal review would be updated through the master plan.

 

From 2021, the ministry would mandate submission of prompt and regular report on safety issues including adverse event, data analysis and evaluation result, and safety control report.

 

And from 2023, the ministry would also mandate collection and analysis of safety issue data from home and abroad and submission of post-marketing safety management report.

 

However, the pharmaceutical industry predicts that items with mediocre sales and limited safety profile data would have gap in data submission, compared to originals with high overseas sales.

 

This is the reason why the industry is concerned possible discrimination in the renewal review procedure.

 

The industry insider in government affairs said, “Amid COVID-19 outbreak, it is frustrating to see the communication channel between the government is cut, when we need to discuss about tools to fill up the gaps it unfolds the new policy.” The insider added, “The government should convene a meeting to exchange questions and answers instead of disseminating information.”