The European Medicines Agency’s new guideline on optimizing pharmacovigilance practice for medicines taken during pregnancy and breastfeeding has been delayed to take into account the need for building consensus with all stakeholders and will now be issued for public consultation towards the end of this year.
The EMA’s pharmacovigilance risk assessment committee (PRAC) was initially due to be consulted on the draft version of the guideline in the second quarter of 2016. This will now take place in Q2/Q3 this year, with PRAC aiming to adopt the draft guideline in Q3/Q4 2017.
The initial timeline proposed to develop the guideline was “adjusted to take into account the need for consensus building,” an EMA spokesperson told the Pink Sheet. When ready, the document will include pharmacovigilance and risk minimization activities in relation to:
- medicines taken during pregnancy
- medicines taken during breastfeeding
longer term effects of medicines taken before and during pregnancy and breastfeeding on infants, children and adolescents.
The guidance document will be included as a new chapter (P III) under the EMA’s good pharmacovigilance practice (GVP) guideline on product- or patient-specific considerations.
PRAC will aim to adopt the draft guideline in Q3/Q4.
The EMA is also developing a new chapter (P IV) on pharmacovigilance requirements for geriatric population. It intends to publish the geriatrics guideline for public consultation in the third quarter of 2017. The aim of this guidance will be to take into account specific issues such as altered physiology, frailty and frequent comorbidity in pharmacovigilance processes, the agency spokesperson said.
The EMA has already issued two other chapters on product- or patient-specific considerations under its GVP guideline on: vaccines for prophylaxis against infectious diseases (P I); and biological medicinal products (P II). (Also see "EU Regulators Ramp Up Safety Monitoring Efforts For Biologicals" - Pink Sheet, 5 Feb, 2016.)
From the editors of Scrip Regulatory Affairs.