MFDS reviews enacting a separate and special law for drugs

Analyzes domestic pharmaceutical environment conditions, surveys areas in need of legal management

The Ministry of Food and Drug Safety (MFDS) is considering enacting a 'special law' to separately manage drug safety management.

 

For this, the MFDS recently launched a call for researchers for the ‘Study for the Analysis of the Legal System of the Pharmaceutical Affairs Act and Review of the Special Act on Drug Safety Management'.

 

The research will be conducted for 7 months from the date the research service is outsourced, and a budget of KRW 50 million will be invested to review reorganizing the legal structure of the ‘Pharmaceutical Affairs Act' in line with the newly changing regulatory environment and to lay the foundation for the enactment of a special law.

 

The 'Pharmaceutical Affairs Act' was enacted in 1953, and has evolved with the development of the pharmaceutical industry, covering a wide range of pharmacist functions and drug licensing, management, and use.

 

The MFDS raised the need for a comprehensive review of the law, explaining, "The law has been partially revised 48 times over the years, limited to only those necessary to introduce new systems and improve operational problems." Therefore, the study will review the legal system and consistency of the law through analysis of the history of the enactment and amendment of the Pharmaceutical Affairs Act, and identify revisions needed under the jurisdiction of MFDS, based on the results.

 

The special law on drug safety management will analyze the domestic pharmaceutical environment and administrative conditions for drug safety management, and conduct demand surveys through industry-wide surveys, etc.

 

The MFDS will conduct a demand survey on major issues and stakeholders' positions on areas that need to be managed by a separate law, the Special Act.

 

In terms of areas requiring drug safety management, the research team will review clinical and licensing, manufacturing and quality control, licensing patent linkage system and data protection system, post-marketing safety management, and the supply system in place for drugs such as essential medicines.

 

The MFDS explained, "Through the study, we will classify, organize, and systematically review the provisions in the Pharmaceutical Affairs Act regarding the areas where special laws need to be enacted.

 

We will also investigate the statutes of special laws enacted in major countries such as the United States and Europe by field with regards to the areas where special laws need to be enacted." In addition, the study will include research on the effective regulatory operation plans for new drugs that cannot be managed by existing laws, such as converged medical products and new drugs utilizing AI.

 

Meanwhile, the MFDS has been enacting and implementing the 'Special Act on Imported Food Safety Management' since February 4, 2016.

 

The Special Act on Imported Food Safety Management aims to improve the consistency and efficiency of the administrative measures posed by unifying the provisions on imported food safety management that were dispersed into the Food Sanitation Act, the Livestock Hygiene Management Act, the Health Functional Food Act, and the Livestock Epidemic Prevention Act.

 

After discussions, the MFDS decided to improve and complement systems already in place in the Food Sanitation Act while maintaining the current status quo, and the scope of regulation was expanded and strengthened by introducing a new registration system for overseas manufacturing companies and establishing new business types such as imported food declaration agencies and internet purchase agencies.