NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

I am still uncertain about the four regulators, who could receive a marketing application or grant approval.

My reason for revisiting this, is, I'm curious as to whether there is any possibility that the fourth regulator is outside of both Europe and N. America. (Japan, Australia, China?)

I'm not particularly interested in who the SAP's went to/are going to. I'm interested in the 'four chances to win', which surely refers to approval and not just giving a nod to an SAP.

As things stand, the EMA centrally approves all ATMP's for member states. So as I read it, neither Germany or the UK can currently grant marketing approval to an ATMP.

Apply for a marketing authorisation for an advanced therapy medicinal product

All ATMPs to be placed on the market in the EU must have a marketing authorisation and are regulated through the centralised authorisation procedure.

The Committee for Advanced Therapies (CAT), established by the European Medicines Agency (EMA), is responsible for preparing a draft opinion on the quality, safety and efficacy of each ATMP that needs a marketing authorisation.

The CAT’s opinion goes to EMA’s Committee for Medicinal Products for Human Use (CHMP) (link) for final approval.

Further information about the CAT, EMA’s role in the regulation of ATMPs and guidelines specific to ATMPs is available on EMA’s website.

https://www.gov.uk/guidance/advanced-therapy-medicinal-products-regulation-and-licensing


But, in the case of the UK, everything is in flux due to the Brexit situation. Most probably in the case of a no-deal Brexit, UK approval responsibility will for ATMP's will revert to the MHRA.

It's probably the case that the MHRA will be the fourth regulator, in addition to the FDA, the EMA, and the Canadian regulator.
But nothing I've heard makes this definitive for me.
And I have seen nothing to suggest that Germany separately receives applications and/or grants approvals.


So I retain a degree of uncertainty about this, and wonder if a different regulator is on the horizon.

I'm not aware of anything that would preclude regulatory application further afield, nor anything that mandates the order in which applications should be made.

If not fourth, who will be fifth?