Hi DD. you may be right that in many cases a CMC update to an ATMP review does not require a PR to shareholders but neither is that requirement in place when a post MAA amendment (variation) is installed and that is exactly what GZ told you that we will have.
I therefore expect an MAA approval based on the artisan methodology
relatively soon and will be waiting for the automatic manufacturing
ASAP thereafter.
" Adding a CMC (Chemistry, Manufacturing, and Controls) update during the initial Marketing Authorisation Application (MAA) review with the MHRA (Medicines and Healthcare products Regulatory Agency) is fundamentally different from submitting a post-approval variation (amendment) because the former is part of the initial assessment of the product's core quality, while the latter is a change to an already approved product, requiring specific variation types (Type IA, IB, II) and regulatory procedures post-licensing. The MAA focuses on establishing the product's fundamental quality, safety, and efficacy, while post-approval variations manage ongoing lifecycle changes, with ATMPs (Advanced Therapy Medicinal Products) having specific quality aspects (e.g., cell processing) impacting this.
MAA Submission (Initial Phase):
Context: You're presenting the complete data for the first time to get approval.
CMC Role: CMC data (Module 3 of the dossier) is foundational, defining the product's identity, quality, and manufacturing process, crucial for the MHRA to assess if the product can be consistently made to a high standard.
ATMP Specifics: For ATMPs, this includes detailed controls over starting materials, cell processing, and release testing, which are inherently complex and scrutinized heavily during the initial review.
Post-Approval Variation (Amendment):
Context: You already have a license and are making changes to an approved product.
CMC Role: The update is classified as a variation (Type IA, IB, or II), depending on the impact on quality/safety, and must follow specific timelines and reporting rules.
ATMP Specifics: Changes to ATMP manufacturing (e.g., new cell line, different viral vector, altered processing) are often substantial and require rigorous Type II variation assessment and formal MHRA approval before implementation.
Key Differences:
Timing & Purpose: MAA is before approval (establishing quality); Variation is after approval (maintaining/improving approved quality).
Regulatory Pathway: MAA is the full application; Variation uses specific post-authorisation change routes (e.g., annual updates for minor changes, Type II for major ones).
Scrutiny Level: An MAA establishes the baseline, while variations manage deviations from that baseline, with ATMPs often triggering more significant variations due to their biological nature.
In essence, your MAA proves the ATMP is good to go; a variation adjusts how it's made once it's already on the market"
Bullish
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