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Saturday, April 04, 2026 1:03:57 PM
10/9/25 Inspection LINK HERE
You'll notice that Advent has received the license for "Procurement" of Tumor (ATMP) material - which Advent did not receive with the previous license.
09/08/23 Inspection LINK HERE
One might wonder if the long delay in the MHRA MAA approval had anything to do with this license for the procurement of tissue.
So I queried AI this question:
For a cellular biologic to receive an MHRA MAA approval, must the manufacturer have a procurement license from HTA?
And received this answer:
Yes, for a cellular biologic (specifically an Advanced Therapy Medicinal Product, or ATMP) to receive a Marketing Authorisation Application (MAA) approval from the MHRA, the starting materials (human tissues or cells) must be procured under an appropriate Human Tissue Authority (HTA) licence.
If the manufacturer does not hold a licence directly, they must operate under a third-party agreement with an establishment that does.
Key details regarding HTA licensing for cellular biologics (ATMPs):
Regulatory Scope: The procurement, testing, and donation of human cells/tissues used as starting materials for ATMPs are regulated by the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
HTA Requirement: Establishments conducting procurement must be licensed by the HTA.
Third-Party Agreements: If a manufacturer is not licensed, the procurement must occur through an organization that is licensed, with a clear third-party agreement in place to ensure compliance with HTA Directions 001/2021.
Joint HTA/MHRA Regulation: Once the starting materials are procured and supplied, the regulation shifts to the MHRA for GMP (Good Manufacturing Practice) in the manufacturing process.
Tumour Material & Blood: HTA licenses are required for the procurement of tissues like tumours. For blood starting materials, a tissues and cells licence or a blood establishment licence from the HTA is required.
In summary, HTA authorization is a strict requirement for the starting materials, which is then verified as part of the overarching MHRA MAA approval process.
And AI provided this helpful HTA link as back up:
CLICK HERE FOR LINK
Which states,
Regenerative medicine and the regulation of advanced therapies medicinal products
HTA licensing for those working with ATMPs
The procurement and testing of human tissues or cells used as starting materials in the manufacture of ATMPs, may only be carried out by establishments holding an appropriate HTA licence or by individuals or organisations working under the authority of a third party agreement with an establishment holding an appropriate HTA licence.
This applies to all tissues and cells which are covered by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended).
And then I asked my AI friend,
Can the receipt of a procurement license for a cellular biologic (ATMP) to receive an MAA approval from the MHRA hold up an MAA?
And this was the answer I received:
Yes, a delay in obtaining a procurement license—specifically a Human Tissue Authority (HTA) licence for the procurement and testing of starting materials—can hold up a Marketing Authorisation Application (MAA) for a cellular Advanced Therapy Medicinal Product (ATMP) with the MHRA.
While the MHRA regulates the MAA itself, the legality of the supply chain depends on proper procurement of starting materials, and the MHRA works closely with the HTA to ensure compliance.
Key Reasons a Procurement License Can Delay an MAA
GMP/GTP Compliance Chain: For an ATMP to receive an MAA, the entire manufacturing chain must be compliant, starting from the procurement of tissues or cells. If the supplier of the starting material does not hold the correct HTA licence, the raw material is considered non-compliant, stalling the quality module of the MAA dossier.
Pre-Inspection Compliance: The MHRA conducts in-depth evaluations of systems and facilities before approving an MAA. Discrepancies in the procurement documentation—such as missing HTA licensing for third-party suppliers—can lead to inspection findings that delay approval.
Third-Party Supplier Qualification: The onus is on the applicant to ensure that any tissues/cells are sourced from licensed establishments.
HTA/MHRA Joint Working: The MHRA and HTA share information regarding tissues and cells used as starting materials, meaning a breach in HTA regulations can immediately impact the MHRA’s evaluation of the ATMP's quality and safety.
Key Considerations
HTA License Requirements: If tissues/cells are being used as starting materials, the donation, procurement, and testing must comply with the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
Blood Starting Materials: For blood as a starting material, the collection can be carried out under either a tissues and cells licence (HTA) or a blood establishment licence.
Timing: The MHRA must know about the manufacturing and sourcing details as part of the pre-inspection compliance report, making it crucial that all licenses are in place early in the evaluation process.
In summary, the procurement license acts as a critical prerequisite for the quality compliance of the ATMP, and its absence or delay can cause significant pauses or rejection of the MAA.
CLICK HERE for AI's supportive LINK:
And it provided some interesting nuggets:
9. Manufacture of unlicensed ATMPs in the UK
There are 2 ways in which unlicensed ATMPs can be made available in the UK:
hospital exemption
the ‘specials’ scheme
Hospital exemption applies for ATMPs which are prepared on a non-routine basis and are used in a hospital with a prescription for a specific patient. To apply for a hospital exemption complete the hospital exemption form and email it to pcl@mhra.gov.uk.
See guidance on the UK’s arrangements under the hospital exemption scheme (PDF, 164 KB, 7 pages).
The ‘specials’ scheme applies to all types of medicinal products. Refer to the MHRA guidance on applying for licences.
Manufacturers need a manufacturer’s licence from the MHRA to use either scheme.
See non-routine guidance on ATMPs (PDF, 661KB, 3 pages).
10. Human tissues and cells in ATMPs
If tissues and cells are being used as starting materials in a medicinal product, the donation, procurement and testing of the cells are covered by the The Human Tissue (Quality and Safety for Human application) Regulations 2007. Under this regulation there are two competent authorities.
The Human Fertilisation and Embryology Authority (HFEA) is the competent authority for the use of gametes and embryos, which may be used in the derivation (development) of cells in the manufacture of ATMP.
The Human Tissues Authority (HTA) is the competent authority for the licensing and inspection for all other tissues and cells. If a human embryonic stem cell line is derived in the UK, a sample of the resulting cell line must be deposited at the UK Stem Cell Bank.
Once the starting materials have been made available, medicines legislation applies and is regulated by the MHRA. Advice on the regulatory routes is available from the Innovation Office.
The MHRA and Human Tissues Authority (HTA) work closely together in this area.
HTA and the MHRA have agreed that the collection of blood as a starting material for an ATMP can be carried out under either a tissues and cells licence or a blood establishment licence. See the joint HTA and MHRA position.
So under the specials program, one didn't require a "Procurement of Tumor Material" license. But one does require that for an MAA.
Super interesting, right?
All of this information does makes one wonder if this "Procurement of Tumor Material" license has been the hold up?
And now we have it.
