European Medicines Agency [to 18 July 2015]
:: FDA, European Commission and EMA reinforce collaboration to advance medicine development and evaluation
US and EU regulators aim to enhance trust in quality, safety and efficacy of medicines
Senior leaders from the United States Food and Drug Administration (FDA), the European Commission and the European Medicines Agency (EMA) reviewed their ongoing cooperative activities and discussed strategic priorities for the next two years at their regular bilateral meeting held on 19 June 2015, at FDA Headquarters in Silver Spring, Maryland, USA.
Over the past years, EMA and FDA have significantly increased their level of collaboration and sharing of information to advance regulatory excellence worldwide. There are now daily interactions, most of them structured around scientific and regulatory working groups or “clusters”. The focus of the cluster reviews during this bilateral was pharmacovigilance, biosimilars, paediatrics and veterinary medicines….
:: Call for civil society members of EMA Management Board
Expressions of interest to be submitted to European Commission by 20 September 2015.
:: How to improve the availability of veterinary vaccines in Europe
EMA publishes workshop report on requirements for the authorisation of vaccines…
:: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2015
EMA to further clarify safety profile of human papillomavirus (HPV) vaccines
The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of HPV vaccines to further clarify aspects of their safety profile. Like all medicines the safety of these vaccines is monitored by the PRAC. The review will look at available data with a focus on rare reports of two conditions: complex regional pain syndrome and postural orthostatic tachycardia syndrome. The review does not question that the benefits of HPV vaccines outweigh their risks.
Article-20 procedure: Human papillomavirus (HPV) vaccines