Safety Observer 188
The EMA started a new consultation on the draft GVP Addendum that covers Pregnancy Prevention Programmes (PPP).
Report 188 — Highlights
FDA: Device or Drug?
The FDA has issued an “Immediately in Effect Guidance” after a Court ruled that the FDA can no longer regulate as drugs the ophthalmic dispensers packaged together with ophthalmic drugs.
EMA Draft Guidance on PPP
The EMA has published a new draft GVP Module XVI Addendum III, which covers Pregnancy Prevention Programmes (PPP) and other Pregnancy-specific Risk Minimisation Measures.
France: Safety Reporting & EU CTR
The ANSM has published Module V and VI of the Notice to Sponsors, which clarify the safety reporting requirements for clinical trials under the new EU Clinical Trials Regulation (EU CTR).
Pakistan GVP Guidelines
The Drug Regulatory Authority of Pakistan (DRAP) has published the first edition of the guidelines on Good Pharmacovigilance Practices for Product Registration Holders.
Malaysia GVP Inspections
The Malaysian authorities have issued guidance to support a new programme of voluntary Good Pharmacovigilance Practices (GVP) Inspections.
