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  • When Timelines Collide: How EMA Regulatory Milestones Can Impact the . . .
    Even a short clock stop of 30 days could reduce the HTD's submission time to just 25 65 days (accelerated standard EMA assessments) Assessment scope changes from label changes or new data could delay the JCA report by up to 18 months
  • CTIS Evaluation Timelines - ema. europa. eu
    introduced a harmonised procedure for the submission of Clinical Trial Applications (CTAs) regarding Clinical Trials (CTs) to be conducted in the EU (whether they are mono-national or multinational) The CT Regulation establishes an
  • Introduction to the EU Regulatory Submission Timeline - Almac
    • By Day 215 –Product information in all EU languages (plus Icelandic and Norwegian) to be submitted by applicant • Day 229 –Member States send comments on translations
  • Lessons on the EU-CTR
    Overall timeline regarding an EU CTR review is considered dynamic Request for Information (RFI) response time is limited (max 10 days during validation and max 12 days during assessment) If a response is not made within the period set by authorities, the trial application will be deemed lapsed Ensure the “right first time” approach
  • The importance of achieving a 180-day assessment timeline for medicines
    Reducing the EMA’s marketing authorisation evaluation period from 210 to 180 days presents a multifaceted opportunity to improve patient access to medicines, encourage pharmaceutical innovation, and attract investment to the EU increasing overall competitiveness
  • Navigating the Landscape of Clinical Trial Applications under the EU . . .
    One of the most significant changes since the EU CTR came into effect in January 2022 is the use of a single electronic portal, the Clinical Trials Information System (CTIS), for the submission, evaluation, and authorisation of a clinical trial, and communication between the Sponsor and Member States Concerned (MSC)
  • Transition of Ongoing Clinical Trials in the EU — Scendea
    Scendea anticipate potential delays in Agency review in the coming months due to the anticipated rush from sponsors needing to transition before the January 2025 deadline, and the resulting backlog issues Therefore, we strongly recommend submitting the transitional application as soon as possible Background
  • REGULATORY COMPARISONS FOR STARTING FIRST-IN-HUMAN . . . - Altasciences
    In the EU and UK, submission of a CTA is via an online portal In Canada, the application is submitted via email in non-eCTD format or a portal (CESG) for eCTD format 60 days for CTA (Part I and II) if no issues ~1 week for validation and 30 calendar days for initial outcome and issuing if the RFI 30-day default review for initial IND filing
  • EU CTR: Practical experiences and lessons learned
    EU CTR states that the RFI response timeline is up to 12 calendar days, however, due to multiple factors the RFI response window may in practice be shorter than those stipulated in the regulation Thus, making it even more important to follow a right-first-time approach for documents submitted
  • Lifecycle management: EU and US variation requirements - TOPRA
    product distributed at risk, 30 days after the FDA receives the sNDA, unless the FDA notifies the applicant otherwise Approval should be completed after six months However, if the submission is rejected, a recall may also be required • PAS: Prior Approval Supplements This category covers major changes that are





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