The standards for medical products excluded from the application for the relief of harm resulting from side effects of drugs have become clearer.

The Ministry of Food and Drug Safety (MFDS) _{식품의약품안전처} recently announced the partial revision of its rule on the “designation of medical products excluded from the relief of harm resulting from side effects of drugs.”

The revision calls for further clarifying standards for excluding the relief of harmful side effects. Instead of deleting the compound list of medicines to be exempt from the relief of harm resulting from side effects, the minister of food and drug safety will announce them.

As the previous notices failed to clarify the “standards of exclusion,” changes in the excluded drug lists have often led to controversies.

To prevent the dispute, the ministry has retained “the scope of exclusion” at the existing level but added some “criteria of exclusion.”

The new provision has added the exclusion criteria of “drugs which reported more than 10 percent of grave adverse drug reactions, including diseases and death, in pre-approval clinical trials or cause side effects to similar extent,” in addition to the existing provision specifying medical products used for cancer and other special diseases and are designated by the minister of food and drug safety.”

The current notice has designated the excluded drugs as “compounds asterisked 1 used to treat cancer asterisked,” or “compound asterisked 2 used to prevent rejection resulting from the transplants of organs or bone marrow.” The new notice, however, will change them to “medical products used for cancer and other special diseases and are designated by the minister of food and drug safety.”

Also, the ministry has worked out grounds for allowing manufacturers of medical products, medical experts, and customer organizations to present their opinions about the exclusion list.

If these parties want to raise an objection or add or delete compounds to the exclusion list, they have to submit the name of a drug, appropriate reason, and documents to the director of Korea Institute of Drug Safety & Risk Management (KIDSRM) 한국의약품안전관리원. The head of the institute writes a review report and submits it to the minister. The minister then can get advice from the deliberation committee about the report. The announcement will go into effect on next Jan. 1.

The ministry said it expects the revised notice will allow for more flexible administration by announcing the list of excluded drugs, and reasonable management of excluded drug compounds by collecting views from related organizations more actively.

lhs@docdocdoc.co.kr

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