Category: Publications
EU Clinical Trials Regulation: EMA steers away from transparency by misinterpreting exception provisions
Joint response to an EMA public consultation
The European Medicines Agency (EMA) must stay true to the Clinical Trials Regulation: non-disclosure has to remain the exception, not become the norm!
Press release and joint response attached as PDF:
European Medicines Agency (EMA) softens its conflict of interest policy: Does this further open the door to undue influence instead of closing it?
28 November 2014
Joint Press Release
At the end of November 2014, the European Medicines Agency has announced the adoption of a “more balanced approach to handling conflicts of interests” to become effective on 30 January 2015. In reality, this revised EMA COI policy relaxes EMA’s position in relation to the conflicts of interest of experts with pharmaceutical companies. The evaluation of the efficacy and harms of medicines must be free from undue influence and be based on scientific data, so that the Agency’s work can benefit public health. The Agency’s integrity is at stake
Newsletter November 2014
Attachment: isdbnewsletter_2014_november.pdf
Medicines are not just a commodity
Medicines are not just a commodity: the International Society of Drug Bulletins (ISDB), the Medicines in Europe Forum (MiEF) and the Nordic Cochrane Centre (NCC) welcome the decision to leave responsibility for medicinal products with Health Commissioner (joint press release).
Attachment: 20141016_dghealth_juncker.pdf