The government said it would limit the healthy number adults can participate in clinical trials to two times from four times a year, to protect study subjects from adverse drug reactions.

The Ministry of Food and Drug Safety on Wednesday reported to the National Assembly’s Health and Welfare Committee that the ministry would strengthen the state management of adverse drug reactions.

To protect participants from adverse drug reactions, the government decided to limit the number of study participation to two times a year and make insurance subscription compulsory.

To enhance punishment on violation of clinical trial conducting criteria such as false reports of adverse reactions occurred during tests, the government will come up with various measures such as imposing punitive penalties, halting new patient registration, and excluding those responsible for the trials by September.

The government said it would also expand the compensation range in the pharmaceutical damage relief system. The damage relief has been limited to reimbursed drugs, but the relief will extend to non-reimbursed treatment costs that were unavoidable.

The government will also strengthen monitoring of side effects, recalls, and tracking of nonconforming products. By June, the ministry will establish a center for research and analysis of the electronic medical records of hospitals, to analyze the causal relationship between drugs and abnormal events. If a side effect occurs, the research center will receive questions. Then, a medical institution will analyze it and take safety measures based on the evaluation result.

To enhance patient safety, the government will manage octafluoropropane gas kit products, currently classified as industrial products, as medical devices from August. Octafluoropropane gas kit products are used in ophthalmology to treat retina. The decision came as blindness occurred in some patients who had a gas injection procedure.

lhs@docdocdoc.co.kr

<© Korea Biomedical Review, All rights reserved.>