The National Assembly is trying to enact GMP legislation

There is a possibility that the Ordinance of the Prime Minister notification will be upgraded to the Pharmaceutical Affairs Act

The MFDS requests an increase in manpower for regular operation of planning and monitoring

As domestic pharmaceutical manufacturers' GMP (Good Manufacturing Practice) violations occur one after another, the National Assembly and the MFDS are struggling to prevent recurrence by strengthening regulations.

 

The National Assembly is considering reinforcing the administrative disposition of pharmaceutical companies violating GMP through the legalization of the Ordinance of the Prime Minister and the Pharmaceutical Affairs Act of the GMP regulation, which is operated by public notice, and the MFDS is trying to organize a special planning inspection team regularly and operate it on a regular basis.

 

On the 4th, the National Assembly and the MFDS are discussing to resolve the problem of GMP violations in Binex, Vivozon, and Chong Kun Dang.

 

The National Assembly is reviewing a bill that raises the current GMP regulations, centering on members of the Health and Welfare Committee.

 

Currently, the MFDS is issuing a GMP conformity certificate based on the Ordinance of the Prime Minister, the safety regulations for pharmaceuticals.

 

Other detailed GMP regulations are managed by administrative regulations.

 

The National Assembly is preparing to legislate as it is necessary to raise and legislate the GMP regulations to the Pharmaceutical Affairs Act rather than administrative rules due to the illegal manufacturing situation of domestic pharmaceutical companies.

 

It is to raise the GMP regulations and conformity assessment to the Pharmaceutical Affairs Act and to establish a legal basis for the cancellation of GMP certification for pharmaceutical companies that violate the regulations.

 

Some pharmaceutical companies' discretionary manufacturing will strengthen the overall pharmaceutical industry's GMP regulations and penalties for violations.

 

The MFDS is planning to request an increase in manpower for the regular organization and regular operation of the GMP special planning and inspection team for pharmaceutical manufacturing establishments, and taking this voluntary manufacturing situation as an opportunity to monitor pharmaceutical manufacturing establishments at any time to strengthen quality control.

 

Currently, the MFDS operates a GMP special planning and inspection team as a TF composed of two teams.

 

In addition, the factory's intentional and unethical illegal activities are being detected.

 

It is the duty to detect acts such as changing the permission information or falsely writing or concealing manufacturing records without approval from the MFDS.

 

The MFDS will appeal to the National Assembly and related ministries about the need to increase manpower in order to incorporate regular personnel in the planning and inspection team in the future.

 

An official in the National Assembly's Health and Welfare Committee said, "The issue of GMP violation has had a significant impact on the overall pharmaceutical industry in Korea, and various changes have occurred.

 

It influenced the legislation of the National Assembly, and the pharmaceutical association and the pharmaceutical industry reflected on themselves.The National Assembly is determining the need to strengthen GMP regulations." He added, "It is a violation of some pharmaceutical companies, but the necessity of strengthening GMP regulations has been steadily raised.

 

If additional legislation can prevent recurrence of drug quality problems, it is a situation that should be discussed prospectively while avoiding over-regulation."