The Ministry of Food and Drug Safety said Thursday that it has revised the Pharmaceutical Affairs Law to set up a basis for the registration and inspection of drug-making plants in foreign countries.
The agency also mandated that such factories must provide insurance for patients participating in the clinical trials.
This revision aims to expand the safety management of medications, protect the health rights of participants in clinical trials, and increase the reliability of clinical trials.
The amendment comes after the domestic drug industry went into confusion, as regulators uncovered carcinogen, N-Nitrosodimetylamine, in the valsartan supplied by China’s medical material maker Zhejiang Huahai Pharmaceuticals.
The new regulations also include improving the safety management system for drugs, prevention of illegal circulation of drugs, and the strengthening of clinical trial safety management.
To improve safety management system for drugs, the ministry will establish the basis for the registration and on-site inspection of overseas factories, specify the consignment manufacturing and sales businesses within the business scope of the Korea Rare and Essential Drug Center, and create the foundation for integrated safety management of medicines.
To prevent the illegal circulation of drugs, the regulatory agency plans to introduce a penalty for those advertising or provide the illicit drugs, while requesting the information of the service providers that helped advertise or arrange the illegal drugs.
The ministry also plans to impose up to 5 percent of the production fee when manufacturing or importing unlicensed pharmaceuticals as a penalty.
Besides, the ministry will require clinicians to comply with insurance and reimbursement procedures, preserve evaluation records for clinical trial drug safety information, and limit the number of healthy people participating in clinical trials from four times a year to two times a year for clinical trial safety management.
“We will continue to improve the system so that the people can empathize with the system,” a ministry official said. “The ministry will also provide a thorough safety management system so that safe and high-quality medicines can be supplied to the people.”