Sounds like delivering on press reform would also be key if we want to protect democracy!

I see frog-face, 'man of the people commodities trader' Farage is also making an appearance. Hope someone asks him whether he's happy that the Brexit he orchestrated cost the UK £140bn, knocked 5% of GDP and made common folk £2k poorer per year.

so well deserved!

It's going to be a *very* stern letter.

The UK was already behind other countries such as Australia, Belgium, USA, Portugal in recognising and facilitating use of non-GMP phages in salvage therapy. I worry things have just been made worse either intentionally (with no supporting evidence), or unintentionally through choice of language.

People are dying now from drug-resistant bacterial infections that phages could treat. Case studies have shown them to be safe and effective time and time again, and in very few of these case studies were GMP-certified phages used.
www.mdpi.com/2079-6382/11...

If the route of using safe, but non-GMP phages in the UK has indeed been closed, one can only hope that the Government accelerates its commitment to consider the case for the development of a UK-based GMP facility to support phage innovators
questions-statements.parliament.uk/written-ques...

In their report, the SITC stated "Regulators should address these issues at pace. The MHRA should consider using a ‘magistral monograph’, as is the case in Belgium, to allow non-GMP phages to be produced in the UK to an acceptable standard for compassionate cases."

It really feels like a regressive move that runs counter to the recognised need for phage therapeutics as outlined by the Commons SITC Select Committee (who tasked the MHRA with providing clear guidance) publications.parliament.uk/pa/cm5804/cm...

So, even if they are just stating their original position, without further clarification, I fear the MHRA has just made it harder to access phage therapy in the UK, and it wasn't exactly easy before
www.telegraph.co.uk/news/2024/10...

Regardless of which interpretation is correct, the likely outcome is that without prior knowledge of the MHRA's position on GMP-like phages being OK to import, the wording of the new guidance very much sounds like 'you can only import GMP phages'.

An alternative interpretation, is that the use of the phrase 'GMP expectations' rather than 'GMP certified' is deliberate and simply clarifies the previous view of the MHRA that imported phage products, didn't have to be GMP certified, but did have to be made under GMP-like processes.

If this is interpreted as phages 'must be GMP certified'. then we can no longer use phages from Belgium, closing a viable (but still challenging!) route to access phages for salvage therapy.

However, section 4.1.2 of the new guidance states "Medicines imported into the UK as unlicensed medicines would be expected to comply with
GMP expectations like unlicensed medicines manufactured in the UK."

Belgium do not make phages under GMP, but they are made in a highly-controlled, GMP-like process. Previously this was deemed sufficient by the MHRA to accept them as of suitable quality for clinical use, and to approve use in UK salvage therapy.

There are no GMP certified phage manufacturers in the UK, so we were reliant on importing phages (usually from QAMH in Belgium). Section 5 of Guidance note 14 allowed this. Importantly section 5 does not stipulate GMP manufacture, but does require MHRA sign-off and assessment of quality.

This is how phages could be used in theory in the UK before. Unlicensed specials made in the UK needed to be manufactured to GMP standard by a GMP certified manufacturer (section 4 of Guidance Note 14)
assets.publishing.service.gov.uk/media/645e19...

On the whole, the purpose of the document appears to be to provide clarity of the existing position, rather than alter the regulation in the UK to make phages more accessible. As an example, it refers to Guidance Note 14 for the supply of unlicensed specials for information.