Clinical Trials Regulatory Affairs Flashcards
What is a Clinical Trial Application (CTA)?
A regulatory dossier submitted to the Health Authority and Ethics Committee before starting a clinical trial.
When is a CTA required?
For investigational medicinal products and approved drugs seeking new indications.
What is the average CTA review timeline in Japan?
14 days.
How long does the CTA approval typically take in the EU under EU-CTR?
~90 calendar days.
When did the EU-CTR go live?
31 Jan 2022 with a 3-year transition period.
How does EU-CTR differ from the previous directive?
EU-CTR centralises CTA submission and harmonises regulatory and ethics reviews via a single platform.
What are the key components of Part I in the CTA submission?
Cover letter, IMPD, protocol, investigator brochure, quality documents, IMP labeling.
What does Part II of the EU-CTR submission include?
Site-specific documents and the Informed Consent Form (ICF).
What is the validation phase timeline in EU-CTR?
10 days.
What is the Part I and Part II assessment timeline?
Each lasts 45 days.
Which country is expected to approve a CTA fastest in the global case study?
Japan.
Name four mandatory documents for an initial CTA submission.
Protocol, IMPD, Investigator Brochure (IB), Informed Consent Form (ICF).
What qualifies as a substantial modification?
Changes affecting patient safety, scientific validity, or trial conduct.
Do substantial modifications require re-approval?
Yes, from both regulatory authorities and ethics committees.
What is the role of Regulatory Affairs in CTA processes?
Coordinating regulatory and ethical submissions, maintaining compliance, managing timelines globally.
What is a key benefit of EU-CTR?
Centralised CTA submission and harmonised approval across EU states.
