Cancellation policy for innovative pharmas certification

Gov't has decided to implement innovative measure for economic regulation…will establish related standards next year

"Strict standards related to illegal rebates discourage novel drug development"

Choi Sang-Mok, deputy prime minister and Minister of Economy and Finance

It has been reported that the cancellation standards of 'Innovative Pharmaceutical Companies Certification' will be relaxed for pharmaceutical companies fined for rebates.

 

Some argue that certification requirements for illegal rebates are strict.

 

Further criticism is anticipated as these measures deviate from the government’s longstanding anti-rebate policies.

 

On December 4, the government finalized the "Innovate Economic Regulatory Plan for Enhancing Corporate Dynamism and Promoting New Industries" at the Emergency Ministerial Meeting on Economic Affairs.

 

This plan was prepared by the Ministry of Economy and Finance and the Office for Government Policy Coordination of South Korea, actively·promptly reflecting suggestions from economic organizations and companies.

 

◆Improvement of certification cancellation standards for 'Innovative Pharmaceutical Companies' = The government has determined that the strict certification requirements related to illegal rebates in the 'Innovative Pharmaceutical Companies Certification' system could discourage pharmaceutical companies from developing new drugs.

 

In detail, the government plans to revise the standards stipulating that certification can be canceled if ▲A company receives two or more penalties for violating the Pharmaceutical Affairs Act due to illegal rebates within three years or ▲The total amount of rebates exceeds KRW 5 million.

 

After consulting with experts from the industry and academics, the government plans to devise a draft for the revision to the cancellation standards for the 'Innovative Pharmaceutical Companies Certification' (according to the Ministry of Health and Welfare notice) next year.

 

Meanwhile, 'Innovative Pharmaceutical Companies Certification' offers several benefits, including: ▲Incentives when participating in government R&D projects related to new drug development ▲Corporate tax deductions for research personnel development costs ▲Eased location regulations for constructing research facilities ▲Special loan arrangements for policy funds.

 

◆'Advanced regenerative clinical research' results to be used for drug approvals = Different standards from clinical trials under the Pharmaceutical Affairs Act have been applied to Advanced regenerative clinical research, making it difficult to use as a basis for approval in developing advanced biopharmaceuticals.

 

Guidelines will be established this month to allow advanced regenerative clinical research results to be used as approval review data for advanced biopharmaceuticals.

 

Guidelines will be established this month to allow advanced regenerative clinical research results to be used as approval review data for advanced biopharmaceuticals.

 

A draft guideline, tentatively titled "Guidelines relating to the Advanced Regenerative Medicine Clinical Research and Marketing Authorization," will be developed to utilize research results that meet specific standards as part of the review data for marketing authorization.

 

◆To introduce simultaneous analysis methods for vitamin B products in functional foods = Currently, the "Standards and Specifications for Functional Foods" do not include a test method for simultaneously analyzing the Vitamin B group (B1, B2, B6, niacin, and folic acid), which has delayed the product development.

 

In response, the government plans to develop·implement a test method capable of analyzing properties across various formulations for functional foods through a research project starting in January next year.

 

◆To develop a pilot service of a health management system for young children·adolescents = A health management service utilizing AI and digital technology will be implemented to minimize long wait times for treatment and reduce public inconvenience.

 

In particular, with declining birth rates exacerbating the reduction of pediatric medical demand and resources, the government aims to develop a health management system for young children to address reduced access to pediatric care.

 

The system will be designed to include AI-based support for diagnosis and treatment guidance, assistance with medical record documentation, health consultations for managing pediatric diseases and providing information to caregivers on pediatric rare diseases.

 

The government will allocate a total of KRW 32 billion over four years for this project.

 

Additionally, the government suggested other innovative measures, ▲Establishment·operation of a regulatory support center for digital medical products ▲Regulatory improvements for consumer direct-to-consumer (DTC) genetic testing for minors ▲Enactment of legislation to promote alternatives to animal testing ▲Support for precision oncology technology development using next-generation sequencing (NGS) panel data ▲Simplification of required documentation for filing innovative medical technology applications.