Your shortness is showing.
“
No. The real question is why does anybody think this relates to NWBIO MAA at all?”
Now let’s think about Flaskworks…
MHRA SI 2025 No. 87 refers to The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025.
This Statutory Instrument (SI) was signed into UK law on January 23, 2025, and is set to come into force on July 23, 2025.
Its primary purpose is to amend the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004 to establish a new regulatory framework for the manufacture and supply of innovative medicinal products that require decentralised manufacture. This specifically addresses:
* Point of Care (POC) medicinal products: Medicines that, due to factors like very short shelf life or highly personalized nature, need to be manufactured at or very near the place where the patient receives care (e.g., in a hospital, community setting, or even at home).
* Modular Manufacture (MM) medicinal products: Medicines manufactured in self-contained modular units that can be deployed to different locations, allowing for flexibility and proximity to patients.
The new regulations aim to:
* Ensure the appropriate quality, safety, and efficacy of these innovative products.
* Provide the necessary regulatory oversight while facilitating increased patient access to these medicines.
* Allow for a more flexible manufacturing approach for products that cannot be produced in traditional, centralized factory settings. The tumor needs to be removed in an operating room, not a factory
The MHRA (Medicines and Healthcare products Regulatory Agency) has published extensive guidance to support the implementation of these new regulations, covering aspects like the designation step for decentralised manufacture, marketing authorisation applications, clinical trial authorisations, good manufacturing practice, and pharmacovigilance.
You’re really going to play stupid? I’m embarrassed for you!
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