Pharmaceutical companies in Korea will have to conduct a test for any impurities, including N-Nitrosodimethylamine (NDMA), a possibly cancer-causing chemical, in their products and report the test results to the Ministry of Food and Drug Safety.
The ministry’s order came after it detected NDMA in ranitidine - and nizatidine-containing synthetic drugs, following the last year’s recall of valsartan due to the carcinogenic risk.
The ministry announced the measure on Friday to control foreign substances in raw drug materials and ordered all drug manufacturers and importers to follow the new rule.
Manufacturers and importers of synthetic drug substances and finished medicines should evaluate the possibility that impurities such as NDMA may be contaminated in the manufacturing or storage process, and report the results to the food and drug ministry by May 2020.
Companies must voluntarily and immediately test drugs that are likely to contain harmful substances, and if they detect any impurities, they should be reported to the health authorities without delay. They should also send an official document displaying the results of the test to the food and drug safety ministry’s pharmaceutical product management division by May 2021.
If a company finds NDMA in a drug, it must report to the food and drug safety ministry immediately and take a necessary measure, such as a recall.
Drug importers may use the results of the evaluation of the original manufacturer overseas, but the final responsibility lies with the importer. Manufacturers of finished medicines can also use the test results by the maker or importer of raw materials, but the ultimate responsibility lies with the finished product maker.
The food and drug safety ministry said it would conduct its study on raw materials that are likely to contain NDMA by August next year.
From September, the ministry will obligate drugmakers to submit data on harmful chemicals before they make any changes in the process of drug approval and manufacturing.
To enhance the management of raw material manufacturing sites overseas, the ministry will also introduce the “Overseas Factory Pre-registration System” next month and expand overseas inspections to confirm compliance, management, and supervision of Good Manufacturing Practice (GMP) standards.
To share safety information with other countries, the ministry said it plans to enhance joint efforts with the European Directorate for the Quality of Medicines (EDQM) for raw materials, with Switzerland’s Swissmedic and Singapore’s Health Sciences Authority (HAS) for GMP mutual certification, and with European Medicines Agency (EMA) for a memorandum of understanding over nitrosamine-group materials.