MFDS, "will make all efforts to pass and land the 1+3 bill"

“To limit co-development and prevent GMP violations… will make efforts to increase planning and monitoring personnel”

MFDS's responses to the National Assembly Health and Welfare Committee’s written QA

The Ministry of Food and Drug Safety announced its plan to pass the revised Pharmaceutical Affairs Act at the National Assembly's plenary session and soft-land the system afterward.

 

The revised Act contains a clause that limits the number of consignees to three for each company that conducts the bioequivalence test for generics and drugs requiring data submission (incrementally modified drugs, iMD).

 

The Ministry also reaffirmed its position regarding the 1+3 bill for generics and IMDs, on how the bill will partially resolve the rampant drug production issue in Korea, and have a positive influence on preventing recurrence of GMP violations of domestic pharmaceutical manufacturers like Binex and Vivozon.

 

In addition, MFDS said it will actively increase its manpower to systemize and operate the 'GMP Special Planning Inspection Team' at all times through discussions with the Ministry of Public Administration and Security.

 

The answers above were provided on May 1st as a response to the written questions sent by the members of the National Assembly's Health and Welfare committee, In-soon Nam, Yeong Suk Seo, and Hye-young Choi of the Democratic Party of Korea.

 

The three lawmakers questioned the MFDS on the countermeasures against GMP violations of domestic pharmaceutical companies, its position on the 1+3 regulation bill, and the direction the domestic pharmaceutical industry should pursue.

 

On the reason why domestic pharmaceutical manufacturers intentionally violate GMP when producing drugs, MFDS pointed to ▲ financial reasons, such as the time and cost of receiving approval for changes ▲ the internal perception that violations are okay as long as the company avoids drug surveillance and ▲ the small scale of punishment.

 

As for countermeasures to prevent recurrences, the MFDS will continue to conduct random spot inspections with the GMP Special Planning Inspection Team while improving the system, with measures such as increasing the punitive fines and implementing one strike-out system for the GMP acceptance test.

 

In particular, the MFDS responded that it was “necessary” to operate the GMP Special Planning Inspection Team at all times.

 

Also, the Ministry added that it will actively implement policies to increase MFDS personnel to allow the Special Planning Inspection Team to operate at all times.

 

“We are grimly aware of the illegal activities conducted by pharmaceutical companies that should have been tending to public health.

 

This is not a universal problem in the industry, but still, we are operating random spot inspections at all times in case similar cases arise,” wrote MFDS.

 

“We believe a year-round operation of the Planning and Inspection Team is necessary to prevent illegal activities in advance.” Also, it wrote, "We will actively discuss measures to increase personnel in local governments with relevant ministries including the Ministry of Public Administration and Security," adding that the Ministry "asks for active support from the National Assembly.” Regarding the bill that restricts sharing bioequivalence and clinical data between companies to prevent rampant production of generics and IMDs, the MFDS strongly agreed on the need for its legislation and promised to make every effort to implement the post-revised system.

 

On the question of how to strengthen the competitiveness of the domestic pharmaceutical industry, the MFDS responded that it intends to make efforts to build a development-oriented pharmaceutical industry by reducing the development period and cost of drugs through measures such as providing advice on clinical trials, technical support after authorization, and training professional manpower.

 

“The domestic pharmaceutical industry has been continuing its efforts to invest in R&D to produce new products, however, the current circumstances are not enough to reorganize the current sales structure that is focused around generic sales competition,” wrote MFDS.

 

“We will foster a development-focused industry environment.

 

The 1+3 bill is one of the measures that may improve the quality of drugs while preventing rampant drug production, so we will do our best to pass the bill at the plenary session.”