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Ministry of Food and Drug Safety to disclose information on clinical trial plans, implementation status, and summary of results'임상시험 정보 등록 공개 제도 도입'

[The Hwankyung Ilbo] The Ministry of Food and Drug Safety announced that it has revised and publicly announced rules on safety of medicines, which include registering and disclosing information on clinical trial plans, clinical trial status, and summary of clinical test results.

Major revisions include establishment of grounds for registering and disclosing information on clinical trial plans, establishment of administrative disposition standard when falsification of clinical trial records is made, and clarification of the target for reporting changes to the clinical trial plan.

The Ministry of Food and Drug Administration (FDA) will disclose information on clinical trial plans, implementation status, and summary of results to provide information for patients who want to participate in the clinical trial and release the information on its website.

The Ministry of Food and Drug Administration said that it would establish a consumer-centered legal system and a thorough manufacturing and distribution management system to ensure the supply and distribution of high-quality medicines.

조수빈 리포터  press@hkbs.co.kr

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