Updating list of effective pages
The European Medicines Agency is organising a webinar on signals and close monitoring, safety specification, product information / reference safety information and the use of summary tabulations on 22 September 2017.
This may seem counterintuitive but it actually makes sense: News Feed has controls for the number of ads a person sees and for the quality of those ads (based on engagement, hiding ads, etc.), but those same controls haven’t been as closely monitored for promotional Page posts.The Agency has published an explanatory note to module VII of the guideline on good pharmacovigilance practices (GVP) providing additional clarification on the content of PSURs.All MAHs should consult the explanatory note when preparing PSURs.Our goal with News Feed has always been to show people the things they want to see.When people see content that’s relevant to them, they’re more likely to be engaged with News Feed, including stories from businesses.MAHs should no longer submit PSURs to national competent authorities directly.
For more information on the changes to the submission of PSURs and how to use the PSUR repository, see: The Agency carries out single assessments of related PSURs for medicines containing the same active substances or combinations of active substances.
It addresses specific challenges in the EU for nationally authorised products, however, it highlights issues that may also apply to centrally authorised products.
The explanatory note will form the basis of the upcoming revision of module VII of the GVP guideline and both documents should be read in conjunction.
For more information, see PSUR roadmap: joint industry/assessor training As of 13 June 2016, MAHs are required to submit all PSURs in the EU to the central PSUR repository, using the e Submission Gateway/ Web Client.
Use of the PSUR repository is mandatory for both centrally and nationally authorised medicines, whether they follow the EU single assessment or a purely national assessment procedure.
They overrule the submission schedule described in Article 107c (2) of Directive 2010/84/EU, and any conditions related to the frequency of submission of PSUR included in the marketing authorisation.