Safety Observer 214
EMA issues revised version of GVP Module XVI on Risk Minimisation Measures.
Report 214 — Highlights
GVP Module XVI on RMMs
The EMA has published Revision 3 of Module XVI on Risk Minimisation Measures (RMMs) and its Addendum on the methods for evaluating the effectiveness of RMMs.
New FDA Draft Guidance
The FDA has announced the availability of a new draft guidance to help assess and mitigate risks related to the user interface of combination products.
MHRA: New PV guidance
The MHRA has announced changes to Pharmacovigilance requirements in the UK following the agreement of the Windsor Framework, which will come into force on 01-Jan-2025.
Medsafe & Clinical Trial Safety
Medsafe launched a consultation on revised guidelines for the conduct of clinical trials in New Zealand. The proposal includes a new document on “Clinical Trial Safety Monitoring and Reporting”.
Safe Use & Pregnancy
A consultation has been launched in France on proposed changes to the pregnancy pictogram, which is presented on the packaging of medicines to warn about their teratogenic or foetotoxic risks.
