EU publishes new drafts of patient information and pharmacovigilance proposals
This article was originally published in Scrip
The European Commission has published the revised proposals on pharmacovigilance and information to patients, following its decision on 2 December last year to separate the two. The two proposals, which each take the form of a draft directive and draft regulation, have now been sent to the European Parliament and the Council of Ministers for discussion.
You may also be interested in...
A legislative provision under which future COVID-19 vaccines can be made available in the UK before they are approved is also being used to offer an unlicensed flu vaccine that officials say has undergone full safety, efficacy and quality tests.
With product shortages made worse by the pandemic, companies in the UK are being asked to use a new system for notifying potential supply disruptions and any plans to discontinue specific medicines.
Two new projects have begun, one on standardizing the assessment of immune responses in individuals vaccinated in clinical trials, the other to improve understanding of potential immunity in patients who have been infected with SARS-CoV-2.