Spring Intro 2023

30/03/2023

Key points to remember in the US • US is almost always the major country that influences clinical development driving strategic decision making and timelines • Defined interaction points between Industry and FDA (“Type B” meetings) • Pre-IND, EOP1, EOP2/pre-phase 3, pre-NDA • Look to align other Agency meetings to get more complete/global feedback • Differences in FDA/EMA approach can usually be accommodated in Global Module 2 documents • Compromise may be required for one or other regions to maintain global Module 2s (potentially sharing multiple different analyses to satisfy both FDA and EMA) • FDA require all raw data in the dossier to perform their own analysis (bottom up analysis) • Can lead to differences in the EU SmPC and US PI reported numbers • Advisory Committee (Ad Comm) often required prior to approval • High resource requirements, High stress levels, often clashes with key points in the EU Marketing Authorisation Application (MAA) How ? Key regions - US

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How ? Beyond EU: GB Post-Brexit

Multiple filing routes to consider: • National Basic Filing Route [called Accelerated Access Assessment] (150 days) • Questions will need to be addressed and will require central resource • European Commission (EC) Decision Reliance Procedure • (initially until 1 Jan 2023 but extended to end 2023) • Submit to MHRA immediately post CHMP opinion • MHRA aims to determine GB MAA within 67 days • Shared/reference/ expedited filing routes: • ACCESS Consortium (previously called ACSS) • ORBIS • Innovation Passport – information still to be released (Dec) • New route for innovative medicines will integrate regulatory & access timeline • “ Rolling review ” Route (New in 2021) to enhance development of novel medicines • Eligibility: Any new active substances including biological products based on submission of a ‘full dossier’, On-going regulatory input and feedback

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