Extension of the interim acceptance decision option
From September 2021 the interim acceptance decision option has been extended to include medicines with MHRA Early Access to Medicines Scheme (EAMS) and/or Innovative Licensing and Access Pathway (ILAP) status. This may support earlier patient access, where a medicine is plausibly cost-effective and data to be generated in the near future is expected to resolve clinical uncertainty.
The abbreviated (therapeutic class) submission route is also a potential entry point to interim acceptance, as well as a full submission.
If an ILAP or EAMS medicine that does not have a conditional marketing authorisation is accepted by the Committee on an interim basis, we will liaise with the company to agree on further regular points of contact about the clinical evidence, to ensure a practical and mutually acceptable date can be set with the company for a full submission.
This change will be effective from September 2021 and there will be no disadvantage to submissions that are currently in process.
More information can be found here
Please contact the secretariat if you require further information at firstname.lastname@example.org