The Ministry of Food and Drug Safety said Tuesday pharmaceutical companies applying for the re-evaluation of new drugs should submit reports on their safety, sales, and approval status on a global scale.
The ministry issued a public notice about a revised version of “Criteria for Re-evaluation of New Drugs.”
According to the revision, a company holding the government’s approval on its new drug should estimate the first sales of the drug during the re-evaluation period. Within three months after the completion of the estimation, the company ought to submit a report that includes the first sales results, analysis, and evaluation of the first sales.
The re-evaluation will also need reports on the drug’s safety and sales status in and outside of Korea. A company with a sales license should submit a safety report based on local and overseas documents and research papers, which should include adverse drug reactions.
The revised criteria went into effect upon the announcement.
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