Materials for medicine reassessment get stricter

Published: 2017-11-23 15:58:44

Updated: 2017-11-23 15:58:44

In the future, when applying for reassessment for a novel drug, a pharmaceutical company must turn in reference data, such as sales and approval records.

On 21 November, the Ministry of Food and Drug Safety(MFDS) officially announced a partial revision to the ‘Reassessment Standards for Novel Drugs’ containing articles about the change of data to turn in.

According to this, it becomes obligat...

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