EU Regulatory Affairs Flashcards
What are key responsibilities of regulatory professionals?
Interpret regulations, identify compliance risks, lead HA interactions, support product launches and MA maintenance.
Name three key EU regulatory bodies.
EMA, HMA, National Competent Authorities (NCAs).
What are the four types of Marketing Authorisation (MA) procedures in the EU?
National, Decentralised (DCP), Mutual Recognition (MRP), Centralised (CP).
What is unique about the Centralised Procedure (CP)?
Single EMA-led approval valid across all EU states (except UK), Iceland, Liechtenstein, Norway.
What is the purpose of the Target Product Profile (TPP)?
Define ideal product characteristics, align regulatory/commercial strategies, aid submission planning.
List key components of a TPP.
Description, indication, patient population, dosage, storage, clinical/safety, regulatory, commercial, IP.
Why is EMA scientific advice important?
Ensures alignment with regulatory expectations and reduces risk of submission failure.
When should scientific advice be sought?
For innovative therapies, SMEs, or deviations from guidelines.
Name 3 EU expedited pathways and their benefits.
PRIME: early support; Accelerated Assessment: 150-day review; CMA: early approval + confirmatory trials.
What are Adaptive Pathways?
Stepwise approvals based on RWE for gradual indication expansion.
What are incentives for Orphan Drug Designation?
10 years exclusivity (plus 2 if paediatric), fee reductions.
What are benefits of a Paediatric Investigation Plan (PIP)?
6-month SPC extension, 10-year protection under PUMA.
What does the MAA include?
Modules 1–5 of the CTD (Common Technical Document).
What are the responsibilities of an EU Regulatory Lead during MAA?
HA engagement, global messaging alignment, brand name management, submission timeline oversight.
What are the three variation types under EU Regulation 1234/2008?
Type IA/IAIN (minor), Type IB (moderate), Type II (major).
How can variation approvals be streamlined?
Group related changes and use workshare procedures.
What are goals of upcoming EU pharma legislation reforms?
Boost R&D, ensure equitable access, address AMR and supply chain resilience.
What is essential for EU regulatory success?
Strategic alignment, planning, use of expedited pathways, lifecycle management, HTA awareness.
