Τρίτη, 22 Μαρτίου 2016

EMA consulation: Draft guideline on GVP - and Draft guidance on format of the RMP

The European Medicines Agency has released for public consultation a draft guideline on good pharmacovigilance practices (GVP) 3 - Module V – Risk management systems (Rev 2) and a draft guidance on format of the risk management plan (RMP) in the EU – in integrated format.

Good pharmacovigilance practices (GVP) module V, released in 2012, advises developers of medicines, marketing authorisation holders and regulators on the design of effective risk management systems and plans. This draft guideline on good pharmacovigilance practices (GVP) 3 - Module V – Risk management systems (Rev 2) is the first major revision clarifyings the activities a risk management plan should focus on during the life cycle of a product. This will help to ensure that a risk-proportionate planning of activities directs resources to areas where the need for additional information and risk minimisation is greatest.

The document open for consultation is available by clicking here.

The European Medicines Agency is consulting stakeholders, through the draft guidance on format of the risk management plan (RMP) in the EU – in integrated format, on an amended risk management plan (RMP) template, to be used by medicine developers. The revision of the template is based on the principles described in the updated good pharmacovigilance practices (GVP) module V in the view of getting a focused risk management system and simplifying the way information is submitted to the regulators.

The document open for consultation is available by clicking here.

Σημειώστε ότι η καταληκτική ημερομηνία για αποστολή σχολίων και για τα 2 έγγραφα είναι η Πέμπτη 31 Μαΐου 2016. Αν επιθυμείτε να εκφράσετε την άποψη σας ή έχετε κάποιο σχόλιο για οποιοδήποτε από τα δύο παραπάνω έγγραφα, επικοινωνήστε με την ΠΕΦ για να σας παράσχουμε τη φόρμα της EIPG για να την συμπληρώσετε και να την προωθήσετε καταλλήλως.

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