Medicines regulator completes impurity data collection
The Ministry of Food and Drug Safety (MFDS) said local pharmaceutical companies have submitted test results for impurities, including N-nitrosodimethylamine (NDMA), a potential carcinogen. The ministry will then do with the data to get the attention of the pharmaceutical industry.
The MFDS said it collected nitrosamine impurity data from all Korean drugmakers on Tuesday.
“Based on the test results, we will take the necessary security measures,” the MFDS said. “We have allowed extended deadlines for those who need more time for testing. It is therefore expected that some will ask for an extension of time.
The MFDS did not disclose the number of pharmaceutical companies that have completed data submissions.
In November 2019, the MFDS asked local pharmaceutical companies and drug importers to review their drug and raw material manufacturing, assess the possibility of nitrosamine impurities, and submit test results by November 2019. May 31, 2022.
The move came after the regulator found NDMA, a WHO-listed Group 2A carcinogen, in blood pressure medications containing valsartan in 2018. The MFDS also detected NDMA in blood pressure medications. -ulcers such as ranitidine and nizatidine in 2019.
In May 2021, Korean pharmaceutical companies submitted reports that predicted the possibility of impurities, including nitrosamine.
This year, the submitted data includes the types of impurities that can be detected in all raw materials and pharmaceuticals, impurity test plans and test results.
The MFDS said it would use the submitted data to identify the types of drugs containing nitrosamine and the cause.
The government also plans to take preventive and remedial measures to safely manage impurities.
The MFDS said it would comprehensively review the data submitted and all drugs containing nitrosamine. Thus, the ministry indicated that certain products previously recognized as safe could be subject to new corrective or preventive measures.
The ministry did not specify the timeline for safety measures because it needs cooperation with regulators in other countries to set criteria for managing impurities.
“While we cannot predict how long it will take to review submitted data, we will do so as quickly as possible,” an MFDS official said.