PharmTech Europe News
Five Additional EU Member States Able to Perform GMP Inspections Equivalent to US Level
November 30th 2018Five additional European Union member states have been confirmed by the US Food and Drug Administration (FDA) as capable of performing good manufacturing practice inspections at a level equivalent to that of the United Sates
Coalition of UK’s Health Sector Request Protection for Public Health Post-Brexit
November 20th 2018A coalition group from the UK's health sector has called on both the UK and EU to ensure the protection of patients and public health when considering the future relationship of the regions post-Brexit.
EMA Publishes Guidance on Pediatric Drug Safety
November 15th 2018The new good pharmacovigilance practice chapter IV on specific considerations for the pediatric population offers a holistic view of pediatric pharmacovigilance and provides guidance on how to address the specific needs and challenges of safety monitoring of medicines used in children.