EU position paper on medical devices
EU position on pharmaceutical products
Up to now the negotiation about the TTIP has avoided health care and has focused on pharmaceuticals and medical devices. This is the latest summary:
Round 9
Pharmaceuticals
The progress of the task force in charge of assessing the equivalence of EU and US Good Manufacturing Practices (GMP) systems was reviewed. Audits of Member States GMP inspectorates observed by US FDA took place and will continue during 2015. The EU will audit the US inspectoratate in September 2015. Other areas such as biosimilars, generics and international cooperation were discussed. The EU welcomed the first authorisation of a biosimilar by FDA. EU committed to submit a proposal for cooperation on generics ahead of next round.
Medical devicesOn May 27th, a meeting in Brussels will be held with all stakeholders. Position papers on both issues are available. The assesment of the whole implications of this Treaty is still pending. A general approach is available in the paper by LSE scholars. The key documents and position papers are here.
The EU presented its position paper on medical devices recently published in the web site. The US asked clarifications on the mutual recognition of quality management system audits concept (one of the objectives detailed in the paper) and its relation with the international Medical Devices Single Audit Programme (MDSAP). The EU noted that while it is committed to MDSAP work, a legal basis needs to be established for it to be able to accept audit reports carried out by US inspectors (TTIP could serve as such legal basis). Both sides took stock of progress on the two other TTIP priorities (Unique Device Identifier -UDI and Regulated Product Submission - RPS). Next steps were agreed for each topic.
A summary of the current regulation is here. As far as there is only limited information I will avoid any opinion about it by now.
PS. Alberto Alemanno paper on TTIP
