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EMA Guidance on GVP for PPP & Parallel EMA/EUnetHTA 21 Consultation

Guideline on Good Pharmacovigilance Practices (GVP) for Pregnancy Prevention Programs

A public consultation was launched by the European Medicines Agency (EMA) for the recently released guideline on "good pharmacovigilance practices (GVP) for pregnancy prevention programs" in the European Union.

This new guidance defines the elements of a pregnancy prevention programme and provides for deciding when such programme is needed or other risk minimisation measures are considered appropriate to avoid adverse pregnancy outcomes due to use of medicines and to preserve health of both the mother and the child.

EMA and the Member States finalized the draft guideline in November 2021 and released it for public comment in March 2022.

EMA expects the finalized guideline will be published in the first quarter of 2023 after the public has had the opportunity to comment on it.

Guidance on Parallel EMA/EUnetHTA 21 Joint Scientific Consultation

On March 4, 2022 EMA updated its guidance parallel consultation guidance and renamed it to “parallel EMA/EUnetHTA 21 Joint Scientific Consultation”.

Key modifications in this version include:

  1. the Written-only meeting format has been suspended for the current Open Call within EUnetHTA 21 (all partners will continue to collaborate and discuss future options for different meeting formats besides the face to face (F2F) meeting format);

  2. Transformation of the early dialogue working party (EDWP) into Committee for Scientific Consistency and Quality for Joint Scientific Consultation (CSCQ JSC), update of the definition and composition of the CSCQ JSC and of the information regarding the EUnetHTA 21 JSC Secretariat

The European Network for Health Technology Assessment (EUnetHTA) was established to create an effective and sustainable network for HTA across Europe. All Parallel Scientific Advices will be conducted through this Parallel Consultation Platform.

For more detailed information on this guidance click this LINK


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