[Reporter's view]Will arbitrary manufacturing be eradicated?

A revision to the Pharmaceutical Affairs Act, which allows the imposition of "punitive fines" on pharmaceutical companies that violate GMPs, passed the National Assembly.

 

It also included canceling the judgment of suitability for the GMP if a violation is found, and allowing a prison term of up to five years or a fine of up to 50 million won, apart from the fine.

 

It contains the will of the MFDS that there is no longer tolerance for deceiving the authorities of permission by false or fraudulent means.

 

What is noteworthy in the revised Pharmaceutical Affairs Act is that a 'GMP exclusive investigator' was appointed.

 

In order to increase the administrative efficiency of GMP investigation and evaluation work, GMP manufacturing and quality control investigators were appointed and pharmaceutical manufacturers were allowed to enter and investigate.

 

It is interpreted that the GMP Special Planning and Inspection Team, which was temporarily operated after a series of GMP violations were detected last year, will be changed to a regular operating system.

 

There has been a role in managing and supervising pharmaceutical companies' compliance with GMP.

 

Article 36 of the current Pharmaceutical Affairs Act designates a "Manufacturing Manager" and manages and supervises the overall drug manufacturing work.

 

But it's actually a private law.

 

Many manufacturing managers have long acquiesced in the evil practice of the name.

 

There are also many expedient ways to fill out related documents in double and then take a new pharmacist to sign them.

 

Manufacturing managers were unable to make a proper opinion from the standpoint of receiving a salary from the company.

 

Pharmaceutical companies forced them to be loyal, and the Ministry of Food and Drug Safety remained unaware.

 

It means that there is no role in managing and supervising drug manufacturing, so GMP violations have not continued.

 

It's just that the law hasn't been used properly.

 

The MFDS has steadily detected GMP violations through the pharmacist monitoring system.

 

According to data released at last year's parliamentary audit, the MFDS conducted 1,277 pharmacist monitoring (regular monitoring + special monitoring) for 5 years and 9 months from 2016 to September 2021.

 

In the process, 485 violations of 189 companies were detected.

 

It means that four (38%) of the pharmacist monitoring were caught 10 times.

 

The problem is that 118 companies have been caught twice or more.

 

There were 45 companies caught more than four times, and two companies were caught more than 10 times.

 

This means that there was no appropriate follow-up by the MFDS even after detecting GMP violations.

 

The main point of the new system is to strengthen surveillance and punishment.

 

The plan is to strengthen surveillance through GMP investigators and impose strong penalties on companies caught to prevent recurrence.

 

Strengthening surveillance and punishment in the new system require appropriate interaction.

 

The focus should not only be on detecting GMP violations.

 

Without proper follow-up measures to prevent recurrence, it is meaningless even if the number of GMP violations is doubled or tripled.