"Any allegation against medicines produced by our members is treated seriously not only by our members but by our regulators." said Dr Virginia Acha, Executive Director - Research, Medical and Innovation.
28 Jan 2016 Posted in By Dr Virginia Acha
"All of our medicines undergo rigorous testing for quality, safety and efficacy by our regulators in the UK, in Europe and globally. This happens not only as part of the licensure process, through both non-clinical and clinical evidence, but in the continuing pharmacovigilance. Our members provide this evidence to the regulators and as recent research has shown (1) our members are meeting their transparency commitments to make clinical trial evidence available, something that will be made a legal requirement with the European Clinical Trial Regulation when it comes into force. We also provide regular safety evidence to the European Medicine Agency (EMA), and the EMA Pharmacovigilance Risk Assessment Committee (PRAC) exists precisely to pursue cases where evidence suggests a review of the risks and benefits of a medicine is required. The potential is there for the PRAC to recommend the removal of a medicine from use, and this has happened in cases already. The review of antidepressants described in the BMJ articles will certainly be reviewed by companies, regulators and other stakeholders; although we still need to reflect on the work, any conclusions from that assessment must be considered alongside all of the evidence and the views of the stakeholders involved, including our member companies."