EU: Heads of Medicines Agencies – Highlights of the 82nd Meeting

Implementation of the EU Clinical Trial Portal to be Postponed Until the End of 2017

Highlights from the meeting include:

• Document “Outcome of the public consultation on the EU Medicines Network Strategy to 2020” adopted, next steps endorsed.
• Implementation of the clinical trial portal to be postponed until the end of 2017.
• HMA is hopeful that as a result of the Transatlantic Trade Investment Partnership (TTIP) negotiations, inspections will be mutually recognized between the US and EU.
• The HMA/EMA Task Force is to arrange a workshop with industry trade associations in Q1 of 2016.
• HMA reconfirmed importance of the HMA Joint Audit Programme (JAP) to guarantee adherence on inspection standards within the EU.
• Improvement of EU medicines authorities’ performances was noted based on BEMA III findings.
• Mandate of the Task Force on the Falsified Medicines Directive successfully completed, formal dissolving of the Task Force endorsed.
• Close links to be maintained with ICMRA developments.
• Two out of three documents comprising Good Practice Guides on Medication Errors delivered by ERMS FG adopted, third document to be adopted via written procedure.
• Formation of a group of Veterinary NCAs to review the current legislation discussed.