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News about GMP/cGMP

2018-08-10

EMA scale back and suspend activities

EMA reported, that it will lauch the next phase of its business continuity plan on 1 October 2018 at the latest. This will allow the Agency to safeguard core activities related to the evaluation and supervision of medicines, while it has to intensify its preparations for the physical move to Amsterdam in March 2019 and cope with significant staff loss.

 

Activities initially impacted by phase 3 include:

  • Collaboration at international level, which will be temporarily scaled back to focus primarily on product-related requests, supply-chain integrity and procedures under Article 58; in other areas, such as the harmonisation of global medicine regulation, EMA will only take a reactive role; EMA’s engagement in other global public health issues such as antimicrobial resistance or vaccines will be maintained as long as possible, but reviewed on a case-by-case basis;
  • Development and revision of guidelines, which will be temporarily limited to those guidelines that address an urgent public/animal health need or are necessary to support and facilitate preparations for Brexit;
  • Holding of non-product-related working parties, which will be temporarily reduced as a consequence of the scaling back of guideline development or revision;
  • Programmes and projects, where activities in relation to project governance will be reduced in line with the reduction/suspension of projects;
  • Organisation and attendance at stakeholder meetings, which will be limited to Brexit-related interactions;
  • Clinical data publication, for which the launch of new procedures will be temporarily suspended as of 1 August 2018; data packages submitted for medicines until the end of July 2018 will be processed and finalised.

The implementation date for phase 3 of EMA’s business continuity plan is 1 October at the latest. Detailed plans for the implementation of these measures are currently being developed and will be communicated to stakeholders concerned and the public as soon as they are available.

 

Source:

EMA

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