[Reporter’s View] Deleting exemptions for industry dev.

Deletion of the special exemption regulation provided for drugs listed on the foreign drug formulary

Until now, the pharmaceutical authorities had partially exempted the safety and efficacy review for ETCs and OTCs listed on drug formularies of 8 advanced countries – the US, Japan, UK, Germany, France, Italy, Switzerland, and Canada - for the prompt introduction of drugs to Korea.

 

This special exemption system for drugs listed in foreign drug formularies was introduced and operated to promote domestic drug approval and production in 1970 in consideration of Korea’s relatively low drug development capabilities then.

 

For the past several years, the system has been repeatedly criticized for impeding the development of the pharmaceutical industry and increasing unnecessary waste of health insurance finances, and there is little need to maintain the system.

 

The Ministry of Food and Drug Safety accepted the National Assembly’s request for discontinuation of such special administrative measures and the regulation that exempts part of the data required for ETC and OTC drug approvals will be deleted from November this year.

 

As a result, the safety and efficacy hurdle for OTC and ETC drugs listed on foreign drug formularies will be raised somewhat compared to now.

 

The domestic industry and MFDS should use the amendment as a turning point to increase the quality and safety level of drugs in Korea.

 

Breaking away from the past when the drugs were more leniently approved just because they were used in advanced countries, the regulatory environment should be restructured in which pharmaceutical companies directly generate and submit safety and efficacy clinical data, and the MFDS reinforces its review expertise in granting marketing authorizations.

 

The Korean pharmaceutical industry today has secured competitivity by improving its own capabilities and even some global competitivity.

 

In addition, the domestic pharmaceutical industry now bears the fate of needing to continuously evolve and develop as the new growth engine and national key industry.

 

Based on the competitivity acquired in the pharmaceutical industry, experts believe that the government should generalize the verification process without exempting approval and review data for drugs taken by the people in Korea to further foster basic growth of the pharmaceutical industry and increase the possibility of development.

 

In addition, more meticulous verification of the efficacy and safety of ETCs that are granted marketing authorization should be made for the more efficient management of health insurance finances.

 

Some have raised the concern that non-essential regulations may be added due to the deletion of the special regulations for drugs listed on the foreign drug formulary, but it is predicted that the domestic pharmaceutical industry and approval and review authorities will be able to discover and approve effective and safe drugs based on the capabilities it had built until now.

 

In 2020, in response to the NA’s criticism regarding the special exemption system for drugs listed in foreign drug formularies, the MFDS Minister at the time, Eui-Kyung Lee, had answered that “The domestic industry has enough expertise to conduct review and assessments..” With the revised regulations this time, it is the reporter’s hope that the pharmaceutical companies prepare data for pharmaceutical approvals based on scientific evidence, and that the MFDS strengthen the drug review environment through self-reviews to strengthen quality-based drug approvals and public trust.