NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

From the MHRA Guidance

From 1 January 2024, the EC Decision Reliance Procedure (ECDRP) will be replaced by the new International Recognition procedure (IRP). The Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) will be incorporated under the umbrella of IRP.

ECDRP and MRDCRP submissions received before 1 January 2024 will be processed under the existing practices. For ECDRP applications, the Committee for Medicinal Products for Human Use (CHMP) positive opinion (but not necessarily the European Commission Decision) should be received before 31 December 2023.

IRP will be open to applicants that have already received an authorisation for the same product from one of MHRA’s specified Reference Regulators (RRs). A CHMP positive opinion or an MRDC positive end of procedure outcome is an RR authorisation for the purposes of IRP.

Regardless of the submission date, this does not change the process in the UK as -L is not approved by any of the other RAs.

For other countries that follow later we will have to see what they do. My guess is that the access consortium countries will likely follow. The big boys likely not. We shall have to wait and see though.