Introduction
Directive 2001 versus proposed new Regulation: throwing out the baby with the bathwater?
Deregulation under the guise of “simplification”
Dangerous change to the definition of a clinical trial “Low-intervention clinical trials”: caution is needed
European Medicines Agency and pharmacovigilance: no to a fee-for-service system
Regrettably, the European Medicines Agency (EMA) is being turned into a mere provider of services to the pharmaceutical industry. Other strategies for funding that would help drug regulatory agencies to be more independent do exist. They should be carefully considered.
Comments on Quality Review of Documents (QRD): revision of the product information – Draft
Submission of comments on 'Quality Review of Documents (QRD) human product information annotated template: revision of the product information - Draft' (EMA/468498/2012)