Allergen Products in the EU
The EU Authorities have launched a consultation on Regulatory Approaches for Allergen Products. The purpose is to harmonise the status of these products that may have a Marketing Authorisation in some countries whereas they may be distributed as Named Patient Products (NPP) in others, with different Pharmacovigilance requirements.
New FDA Draft Guidance
The FDA has issued two new draft guidance documents that are intended to address the gap in scientific knowledge regarding the safety of drugs and biological products during pregnancy or breastfeeding.
MHRA and GCP Serious Breaches
The MHRA Inspectorate has posted a new article on its blog, which provides information and guidance in the wake of the publication of the 2018 report on GCP Serious Breaches, most of which relate to Patient Safety.
Cobert's Manual: 3rd Edition
Cobert's Manual of Drug Safety and Pharmacovigilance is a valuable manual for those working in the field. The third edition has just been published and is now available for purchase.
Hot topics are taken from Safety Observer Lite 157, June 2019