EMA issues new draft GVP guidance
The EMA has released for comments the draft of a new Product or Population-specific considerations guidelines, which covers the population of pregnant and breastfeeding women.
EMA & Signal Detection
The EMA has announced that the Signal Detection Pilot, which started on 22-Feb-2018, has now been extended until the end of 2021 following the review of the experience gained in the first year of the pilot.
New EMA report on PV legislation
The EMA has issued a new report on the implementation of the Pharmacovigilance legislation, which describes the key achievements over the period 2015 – 2018 and their impact on public health.
New GVP Guideline in Algeria
The CNPM has published a new Guide that describes the Pharmacovigilance System in the country and the role of the stakeholders. The guide covers various topics and brings new changes to the safety reporting requirements.
Hot topics are taken from Safety Observer Lite 163, Jan 2020