Bioequivalence reevals speed up in line with drug price reev

Authorities plan to strengthen communication with the industry... CHORUS’s 2H workshop set for this November

MFDS plans to require all generic prescription drugs to be subject to equivalence tests from this year

With the number of items requiring equivalence tests expanded as such, the Ministry of Food and Drug Safety is also accelerating the reevaluation of those that were previously approved.

 

In particular, it is said that the review is being further accelerated this year as its timing overlaps with the reevaluation of the insurance price ceiling amount, which requires self-bioequivalence tests.

 

So-Hee Kim, Director of the Bioequivalence Evaluation Division at the Ministry of Food and Drug Safety's National Institute of Food and Drug Safety Evaluation, said so at a press briefing it had held together with the Drug Evaluation Department.

 

Director Kim explained, "The initial results of the Ministry of Health and Welfare's 'insurance price ceiling reevaluations (standard requirements)' have come out, and pharmaceutical companies are showing mixed responses based on their results.

 

At the time of the drug pricing reevaluations that were conducted, the MFDS reviewed the equivalence reevaluation of many items in a short period of time, and have completed the first review and are reviewing the data again,” The MFDS has expanded the scope of equivalence reevaluations to include all prescription drug generics, starting with oral tablets (uncoated tablets) this year, tablets (film-coated tablets) in 2024, and capsules, granules, and syrups in 2025.

 

For the equivalence reevaluation, subject companies would have to submit a bioequivalence testing result or plan by March of every year.

 

If the companies find it difficult to submit the test result report by then, they may first submit a plan, and submit the results by December after completing the test according to plan.

 

The reevaluation results will be released around February of the following year.

 

The problem was the drug price reevaluations that took place this year.

 

Generic drugs subject to drug price reevaluations had to satisfy both requirements - conducting bioequivalence tests and using registered raw drug substances - to receive the highest insurance price.

 

For items that are subject to both equivalence reevaluations and drug price reevaluations, it was difficult for the companies to submit a notice of completion of their bioequivalence tests in accordance with the drug pricing reevaluation schedule under the Ministry of Food and Drug Safety’s plan.

 

Kim explained, “ The MFDS also had to conduct many equivalence reevaluations in a short period to meet the pricing reevaluation schedule.

 

The review of the items subject to drug price re-evaluation has been completed, and we are now reviewing the remaining equivalence re-evaluation data.” For companies to receive the highest price, the MFDS had to submit a notice of completion of the equivalence reevaluation review to HIRA within the drug pricing reevaluation period, which forced the MFDS to also accelerate its review.

 

Kim said, “Pharmaceutical companies have been expressing difficulties.

 

We have been guiding ways to resolve their issues to help them follow the government’s policies.”

(from the left) Sang-Ae Park, Director of the Advanced Drug Quality Division, Mi-Jung Kim, Director of the Pharmaceutical Standardization Division, Young-Rim Kim, Director-General of the Drug Evaluation Department, Ho-Jung Oh, Director of the Oncology and Antimicrobial Products Division, So-Hee Kim, Director of the Pharmaceutical Standardization Division

Regarding the need to engage in continuous communication with the pharmaceutical industry to respond to various issues including the recent reevaluations, Young-Rim Kim, Director-General of the Drug Evaluation Department, explained the plan.

 

Director-General Kim said, "Last March, we launched CHORUS (CHannel On RegUlatory Submission & Review) to discover two-way agendas between the industry and the MFDS industry, and we are forming and have been operating five branches to allow various companies to cooperate with working-level members that directly carry out the actual work.” He added that CHORUS plans to announce the performance of each branch this year and establish a plan for next year at the H2 CHORUS workshop.

 

In addition to related associations and industry meetings, it plans to strengthen communication with companies that directly meet reviewers.

 

Director-General Kim said, “We have procedures in place so that companies can officially request a supplementary meeting or in-person consultation when applying for marketing authorizations.

 

The temporary restrictions made on phone consultations for relevant departments due to COVID-19 have been lifted.

 

Now, companies can call for consultation without any time limit.” However, as only 124 review personnel are available in the Institute which needs 135, the institute lacks the manpower to address the absolute number of civil complaints.

 

For example, the U.S.

 

FDA has 8,000 review personnel.

 

Director-General Kim said, “We will take the domestic pharmaceutical industry environment into consideration, adjust the timing, and approach it step by step to ensure that the policy is well established and implemented, and we will fully listen to the industry’s opinions during the process.”