All prescription drugs to hand in bioequivalence test result

3-step expansion on subjects, in order of oral, aseptic techniques, and others

Response to too many generics in market, bioequivalence regulation to cost 164.4 billion won

Specification submission leaves no exception, CMOs to also hand in GMP evaluation results

Subject for bioequivalence test is to expand out to all prescription drugs.

 

Also, drug specification with test criteria and procedure would be required, as well as Good Manufacturing Practice (GMP) evaluation result from external contract manufacturing companies.

 

Korean Ministry of Food and Drug Safety (MFDS) announced on Nov.

 

18 its plan to enact partially revised ‘Regulation on Pharmaceutical Safety’, as a follow-up to the excessive commercialization of generics and last year’s valsartan incident with carcinogen contamination.

 

The ministry is to accept public opinion on the matter until Jan.

 

20, 2020.

 

For Korean pharmaceutical industry that bases most of business off of generic products, the revised regulation is the most detrimental level of regulation to hinder the industry.

 

Some of regulations were previously alleviated on a moderate level, but they are now tightened back again.

 

◆ Bioequivalence test for all prescription drugs: First, all prescription drugs are to be gradually obligated to hand in bioequivalence test data.

 

Currently only prescribed tablet, capsule, suppository and other specific drugs designated to provide bioequivalence test result were required to submit the material.

 

About 60 percent of prescription drugs are included in the said subject group.

 

But from now on, the applicable drug regimen types would expand out to all kinds.

 

The administration method types required to provide bioequivalence test material would expand on oral in 2020, aseptic techniques including injection in 2021, and all the other types in 2022.

 

Based on its cost-benefit analysis, MFDS projects affected pharmaceutical companies would spend about 164.4 billion won according to the revised regulation.

 

The analysis estimated a single case of bioequivalence test would cost about 220 million won.

 

◆ Specification submission exemption removed: All prescription drugs would be obligated to hand in specification material.

 

Specification, containing pharmaceutical test procedures and acceptance criteria for new drug, is to provide information on the drug’s manufacturing and test methodology and criteria for quality control, which also includes evidence and test performance data.

 

Except for biopharmaceuticals, currently a drug listed on an official compendium, such as Korean Pharmacopoeia, was exempted from the material submission.

 

Some officially recognized compendium include Korean Pharmacopoeia, Korean Herbal Pharmacopoeia, Good Manufacturing Practice criteria, and other official compendium or pharmacopoeia acknowledged by Minister of Food and Drug Safety (i.e.

 

U.S.

 

Pharmacopeia, Japanese Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia, German Pharmacopoeia, and French Pharmacopoeia).

 

However, there would be no exception from now on.

 

As of 2017, 51 percent of prescription drugs applying for approval were listed on the official compendium.

 

MFDS suspects additional cost would be spent on evaluation service fee, as companies would already have documented specification related materials.

 

The industry is expected to spend about 3.2 billion won, due to the revised regulation.

 

◆ CMOs to hand in GMP evaluation results: Besides the bioequivalence test, MFDS is also requiring contract manufacturing organizations (CMOs) to submit GMP status report and evaluation results.

 

At the moment, the submission is exempted for drugs wholly manufactured in contracted manufacturer.

 

GMP status report and evaluation result should include manufacturing plant floor plan, plant facility and environment management information, GMP-dedicated organization chart and related documentation rules, product specification related to applicant item, record of product and quality control, and copy of validation result.

 

MFDS analyzed that annually 738 items are manufactured by CMOs.

 

The ministry deduced the average number based on approved CMO products from 2012 to 2017, assuming items sharing joint bioequivalence test result are entirely manufactured in external facility.

 

The health authority estimated the revised regulation would have companies to spend about total of 3.7 billion won.

 

MFDS also clarified no additional documentation on GMP evaluation is required other than the materials filed by the client company, but explained additional cost would be probably spent on human resources and evaluation service fee.