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  • MFDS prepares a list of pre-requisite data for inspections
  • by Lee, Hye-Kyung | translator Kim, Jung-Ju | Feb 7, 2023 05:47am
of overseas manufacturing plants
Efforts to improve administrative predictability and consistency after the regulatory innovation industry meeting
The Ministry of Food and Drug Safety has prepared a list of pre-requisite data for local inspections of overseas pharmaceutical manufacturing plants. A total of seven data submission lists, including the list of drug manufacturing over the past three years, have been prepared to enhance the predictability and consistency of administration during field inspections of overseas manufacturing plants. This list of data is one of the suggestions submitted by the pharmaceutical industry through the first meeting of the regulatory innovation industry in the pharmaceutical sector held in July last year.

At the time, the pharmaceutical industry requested that data should be prepared at the site of due diligence and submitted
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