INTERNATIONAL NEWS MARCH 2017

ElisaNews EN

First anniversary of PRIME – experience so far

Registration opens for stakeholder meeting on 19 May 2017

The European Medicines Agency (EMA) is organising a meeting with its stakeholders to review the experience gained with its PRIME (PRIority Medicines) scheme one year after it was launched.

The aim of the meeting is to:

  • receive feedback from users and potential users of the scheme;
  • provide information on how the rules on eligibility have been applied and what types of support applicants have received so far;
  • discuss practical examples that illustrate the benefits of PRIME and how it builds on existing tools.

The meeting will bring together medicine developers who have applied to PRIME as well patients, healthcare professionals, academics, industry representatives and health technology assessment (HTA) bodies. Representatives of EMA’s scientific committees, which have a key role in the operation of the scheme, will present their perspective.

People interested in participating are invited to register by sending the registration form to prime2017mtg@ema.europa.eu by 21 April 2017. As the number of spaces is limited, EMA will allocate places per stakeholder group to allow attendance of a wide range of stakeholders. The event will also be broadcast live on the EMA website. Anyone can follow the broadcast by clicking on the ‘multimedia’ tab on the event page on the day of the event.

 

EU recommendations for 2017/2018 seasonal flu vaccine composition

EU vaccine composition advice is based on WHO recommendations

The European Medicines Agency has issued the European Union (EU) recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2017.

Trivalent vaccines for the 2017/2018 season should contain these three virus strains:

  • an A/Michigan/45/2015 (H1N1)pdm09-like virus;
  • an A/Hong Kong/4801/2014 (H3N2)-like virus;
  • a B/Brisbane/60/2008-like virus.

For quadrivalent vaccines with two influenza B viruses, a B/Phuket/3073/2013-like virus in addition to the strains mentioned above is considered appropriate.

These recommendations also apply to the manufacture of live attenuated influenza vaccines.

Every year, EMA’s ad hoc Influenza Working Group issues EU recommendations for the composition of seasonal influenza vaccines on the basis of observations by the World Health Organization (WHO). The recommendations for the influenza season 2017/2018 were endorsed by the Agency’s Committee for Medicinal Products for Human Use (CHMP) on 23 March 2017.

The Agency recommends that marketing-authorisation holders submit applications to change the composition of centrally authorised seasonal flu vaccines by 12 June 2017.

 

Report from the CMDh meeting held on 20-22 March 2017

Revision of the CMDh procedural advice on changing the RMS Following the triggering of Article 50 of the Treaty on the European Union by the United Kingdom and in preparation of Brexit, the CMDh, in liaison with HMA, has agreed an update of the CMDh procedural advice on changing the RMS. “The RMS has triggered Article 50 of the Treaty on the European Union” has been added as a justifed reason to request a change of the RMS. No changes to the usual procedure have been introduced. Agreement of both current and future RMS needs to be sought by the MAH as outlined in the document. As already stated in the paper, switches can only be performed when no pending procedures are outstanding. Applicants intending to switch should confirm that all procedures submitted are finalised before the switch. The updated document will be published on the CMDh website under “Procedural Guidance, General Information”