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Tuesday, February 13, 2024 11:48:31 AM
Meanwhile:
MHRA February 12, 2024
Therefore, we are now in a position to confirm that an MAA is held for DC-Vax-L.
MHRA February 12, 2024.
We understand that this market authorisation application applies for this product to be used in a serious condition that is often associated with poor prognosis. However, the benefits and risks still need to be carefully weighed and considered. Please be assured that our assessment teams will endeavour to complete their reviews and assessments as soon as is reasonably possible without compromising on safety considerations.
🔑MHRA 2023/2024 business plan.
….Our explicit commitment to ‘risk-proportionate regulation’ also represents a significant intent to increase regulatory oversight on high-risk medical products, applications and indications, especially in relation to new technologies, with a parallel reduction in regulatory oversight on products where there is clear evidence of a lower risk to patients.
https://www.gov.uk/government/publications/mhra-corporate-plan-2023-to-2026/medicines-and-healthcare-products-regulatory-agency-corporate-plan-2023-to-2026
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