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Timelines & submission scheduling

A company may make a submission for a product once it has received a positive opinion from the European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP) or approval from the Medicine and Healthcare products Regulatory Agency (MHRA). The usual assessment timeline is 18 weeks, i.e. from scheduling of a submission to publication of advice. A longer timeline, e.g. 22 - 26 weeks, is required for submissions for:

  • end of life / orphan medicines that require a Patient and Clinician Engagement (PACE) meeting
  • medicines with a complex patient access scheme (PAS) and
  • occasionally for complex submissions e.g. ones which include multiple clinical studies or analyses.

The 18 week detailed product assessment timelines are available here. These timescales are a guide only and in periods where a high number of submissions is received we may need to prioritise submissions to meet the needs of patients, prescribers and the healthcare system.

When it is necessary to prioritise submissions for assessment we take into account factors including:

  • Patient need. As agreed with NHS boards and the industry User Group Forum, we may prioritise submissions for medicines where there is exceptionally high patient need. For example, a submission for a medicine used for a condition where no other treatment is available may be prioritised over one where an alternative treatment is available.
  • Health service need. This includes consideration of, for example, a situation where an unlicensed product is currently being used or where an existing treatment requires a specialist service for delivery.
  • First in class medicine. A submission for a 'first in class' (i.e. the first of its kind) medicine would generally be given a high priority.
  • Date that product is due to become available in the UK. A submission for a medicine that is already available may be prioritised over others that do not yet have marketing authorisation.
  • Patient Access Scheme Assessment Group (PASAG) timeline. If a submission involves a complex PAS, NDC will not consider the medicine until a PASAG decision on the operational feasibility of the scheme is available.