The GMP reinforcement bill passed the plenary session

신약개발 제약사 지원 지속 가능·GMP 위반 처벌 세져

Sustainable Support for New Drug Development Pharmaceutical Companies Increasing Punishment for Violations of GMP A bill to extend special cases for innovative pharmaceutical companies and a bill to significantly strengthen the level of GMP regulatory management compared to the previous one passed the plenary session of the National Assembly on the night of the 29th.

 

With the revision of the Special Act on the Promotion and Support of the Pharmaceutical Industry, the deadline for special provisions on the construction of research facilities for innovative pharmaceutical companies and exemption from various levies will be extended to March 30, 2032.

 

It is expected that it will continue to support innovative pharmaceutical companies that lead the development of new drugs in the future and boost investment in the biohealth industry.

 

The level of regulation will increase as the National Assembly passes the revision of the Pharmaceutical Affairs Act, which promotes the improvement of the quality of domestic distributed drugs by strengthening the standards for drug manufacturing and quality management.

 

The standards for drug manufacturing and quality management are strengthened to secure the effectiveness of the system and strengthen the international competitiveness of products, ▲ upgraded the basis for determining compliance with drug manufacturing and quality control standards (GMPs) to the law, ▲ establishment of sanctions standards for serious violations, such as being judged to be suitable for GMP by false or illegal means, ▲ appointment of GMP investigators and grounds for entry, and ▲preparation of the basis for publication of the details of disposition to drug-related business operators whose administrative disposition has been confirmed.

 

Currently, in order to manufacture and sell medicines, the MFDS stipulates that they are suitable for GMP by formulation or manufacturing method, but it was raised to the law to strengthen the management of serious violations related to GMP.

 

Sanctions standards have been established for serious violations related to GMP-related violations, punitive fines, and penalties of up to 5 years or 50 million won.

 

In order to increase the administrative efficiency of GMP investigation and evaluation work, GMP education and training were appointed as manufacturing and quality control investigators for medicines, etc., and provided a basis for entry and investigation.

 

The head of the MFDS has prepared a basis for informing the public of the violation and the details of the disposition to those whose administrative disposition has been confirmed.