Regulatory Roadmap for the development of human medicinal Products (Europe focus)
Just click on the various stages below to reveal the information.
|DESCRIPTION||Under the medicines legislation which was implemented on 30 October 2005, marketing authorisations (MAs) will be valid for five years and then may be renewed on the basis of a re-evaluation of the risk-benefit balance. Once renewed, the marketing authorisation will be valid for an unlimited period unless there are justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal. In addition, the five-yearly cycle of Periodic Safety Update Reports (PSURs) with renewal has been replaced by a three-year cycle.|
Periodic Safety Update Reports (PSURs)
GMP : Product Manufacturing
Renewal of licences
Computer Systems Validation
|OUTPUTS||Renewed Product Licence|