International news October 2016

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Hma Management Group

The Heads of Medicines Agencies (HMA) Management Group, as endorsed during the Irish Presidency in 2004, has as its main-objectives the co-ordination and facilitation of the operation of HMA, and the supervision and management of the HMAPermanent Secretariat.
The current composition of the HMA Management Group is:

  • Klaus Cichutek (Paul Ehrlich Institute, Germany), as Chairperson
  • Belén Crespo (AEMPS, Spain)
  • Luca Pani (AIFA, Italy)
  • Thomas Heberer (BVL, Germany)
  • Peter Borriello (VMD, United Kingdom)
  • Hugo Hurts (CBG-MEB, Netherlands)
  • Ian Hudson (MHRA, UK)HMA Procedures and Governance for the Permanent Secretariat Support to the HMA Management Group have been updated in September 2016

EMA website and online applications will be temporarily unavailable

All European Medicines Agency (EMA) information technology (IT) systems will be temporarily unavailable from 18:00 on Friday 28 October to 6:00 on Tuesday 1 November 2016 (UK time), due to an essential exercise to test the Agency’s IT recovery processes in case of a major event.

EMA Management Board: highlights of October 2016 meeting

The Management Board heard an update on EMA’s activities in the first half of 2016. In human medicine, EMA’s new scheme to support the development of promising medicines addressing unmet medical needs (PRIME) has been successful so far; 48 applications were received between its launch on 7 March 2016 and the end of June; to date, 64 applications have been received*.
Overall, the number of new applications for marketing authorisation received in the first half of 2016 was comparable to that received during the same period in 2015 (42 in the first half 2016 versus 45 in the first half 2015).