The EMA started a new consultation on the draft GVP Addendum that covers Pregnancy Prevention Programmes (PPP).
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.
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.
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).
The Drug Regulatory Authority of Pakistan (DRAP) has published the first edition of the guidelines on Good Pharmacovigilance Practices for Product Registration Holders.
The Malaysian authorities have issued guidance to support a new programme of voluntary Good Pharmacovigilance Practices (GVP) Inspections.