Pharmacovigilance quality management specification

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In: Medicine/medical devices
On May 13, the National Medical products Administration issued the “quality management specification for Pharmacovigilance quality management “, which shall be implemented officially as of December 1st, 2021. The holder of a drug listing license shall complete the registration of information in the national adverse drug reaction monitoring system within 60 days from the date of the announcement. The specification is applicable to Pharmacovigilance activities carried out by drug listing license holders and drug registration applicants who are allowed to carry out drug clinical trials. It clarifies the responsibilities and requirements of the holders and applicants in drug alert work,Read More →

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