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The status of clinical trials is reported annually

By Lee, Tak-Sun | translator Choi HeeYoung

21.10.19 09:53:25

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Priority review targets such as drugs for severe and rare diseases are permitted within 40 days

The MFDS announced the legislation of partial amendments to related rules


The subject of conditional approval and Priority review will be more clarified, and follow-up management will be strengthened. Previously, conditional approval regulations were in the notice, but it is expected that management and operation will be strengthened, including related contents in the Pharmaceutical Affairs Act, and procedural justification will be secured. The MFDS announced on the 19th that it had announced some amendments to the rules on drug safety.

The revision was prepared to stipulate detailed standards for matters delegated by the revised Pharmaceutical Affairs Act on July 20. The revised bill included ¡ãsimplification of the sample collection procedure for drugs approved for shipmen

Lee, Tak-Sun(hooggasi2@dailypharm.com)
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