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The European Commission Decision Reliance Procedure (the
“Reliance Procedure”) was introduced after Brexit as a
way of ensuring patients in Great Britain were not denied access to
new medicines as a result of the the new requirement that they be
separately authorised by the MHRA. The Reliance Procedure allows
the MHRA to rely on positive European Commission decisions in order
to fast track the approval process for GB marketing authorisations,
with the MHRA aiming for approvals to be issued within 67 days from
the date of the positive EU opinion.
On 30 September 2022 the MHRA announced that the Reliance Procedure
would be extended by an extra year to “ensure
British people continue to have timely access to medicines while
MHRA develop proposals for a new international reliance
framework“. Although details are scarce, another recent
announcement, published on 24 January 2023, provides a little more
information about the new system – an expanded version of the
existing Reliance Procedure (by continuing to rely on EMA
decisions) which would also cover authorisations from
“certain other regulators”.
It is not yet clear which regulators might be included in this
expanded system, but it is worth noting that since January 2021 the
MHRA has already been working with a number of different regulatory
authorities in Project Orbis, a programme set up by the FDA in
2019 to allow international collaboration on the submission and
review of new cancer treatments. Project Orbis now includes
regulatory authorities from the US, UK, Australia, Canada,
Singapore, Switzerland and Brazil (but not the EMA).
This recent announcement will no doubt be welcome news to
companies who see Great Britain as a key part of a
multi-jurisdictional launch strategy. Whilst the current system was
introduced to align the GB approval process with the EU, allowing
the MHRA to “piggy-back” on potentially speedier
authorisations from other regulators might present other
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