Surprise order by MFDS for all substance impurity risk test

Pharmaceutical industry “Found out from news, quickly looking for testing facility”

MFDS refers to EU and other foreign regulators requiring test results

The Korean pharmaceutical industry is shook up as Ministry of Food and Drug Safety ordered companies to conduct tests on impurity contamination in all synthetic active pharmaceutical agents.

 

Other foreign health authorities like European Medicines Agency (EMA) has released a new templates of carcinogen risk evaluation and confirmatory testing for pharmaceutical manufacturers fill in.

 

But the Korean regulator caught Korean pharmaceutical companies by surprise.

 

At the moment, unprepared companies are in a hurry to find a testing lab.

 

After the decision has been made to ban sales on 13 nizatidine products found with cancer-causing compound N-Nitrosodimethylamine (NDMA), MFDS ordered Korean pharmaceutical company on Nov.

 

22 to conduct an impurity risk test on all of their active ingredients to reinforce drug substance safety control.

 

Accordingly, active pharmaceutical ingredient manufacturing and importing companies, and complete product manufacturing and importing companies are to evaluate and test for impurity risk in active ingredients.

 

The risk evaluation result should be reported to MFDS by May 2020, and complete test result by May 2021.

 

Impurity risk evaluation comprehensively analyzes and evaluates possible risk of impurity contamination in active agents based on effect of substance manufacturing procedure, self-decomposition and complete product storage conditions.

 

The tests should follow test procedure verified by a Korean Good Manufacturing Practice (GMP) certified manufacturer, MFDS designated quality test institute, or city and provincial-managed environment research lab, according to test methodology officially disclosed by either Korean or international regulators.

 

And also companies with at least three product serial numbers in the market are required to take the tests.

 

MFDS stated Korean whole drug manufacturer may substitute required test result with data from active agent manufacturing and importing companies, but the ministry pressured that the ultimate liability would be on the companies.

 

The pharmaceutical industry clearly seemed perplexed with the news.

 

A mid-sized pharmaceutical company frustrated with the government order and complained, “The ministry unilaterally released the news on the media without a proper notice.

 

So we are at a loss.

 

They say there is an impurity risk evaluation program, but we are not sure if it could actually test all active ingredients.” Many also complain about overall cost and required time for the test are unknown.

 

A top pharmaceutical company insider commented, “If the required materials can be substitute with active ingredient manufacturer’s data, then more than a half of products are off the hook.

 

But for smaller-scale substance manufacturing companies may not have evaluation material, so probably complete product manufacturing companies would have to take the bullet”.

 

But testing for agents with risk of impurity contamination definitely puts a strain on the industry.

 

MFDS has reportedly disseminated an official notice demanding companies to hand in nizatidine product test results by next year.

 

“Apparently, there are only a handful of laboratories able to test drug substances.

 

As many pharmaceutical companies would rush to get the test done, our company is also promptly looking for a testing facility”, an executive from a mid-sized company explained.

 

Companies are concerned that testing price skyrocket from a normal rate of one million won per a case to few millions per a case.

 

“Regulators in EU and Switzerland have recently decided to reinforce safety management by requiring companies to submit impurity risk evaluation and test results of synthetic drug agents.

 

MFDS plans to continue tightening regulation for active pharmaceutical ingredient safety control”, said MFDS official.