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.
16 November 2015
82nd HMA Meeting
Dubrovnik, 21-23 October 2015