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April 2022

Safety Observer 188

The EMA started a new consultation on the draft GVP Addendum that covers Pregnancy Prevention Programmes (PPP).

Released 08-Apr-2022
Pages 33

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EMA Draft Guidance on PPP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.

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