The European Medicines Agency (EMA) has officially launched Step 2 of the eCTD v4.0 Technical Pilot, focused on Centrally Authorised Products (CAP). This phase invites a limited number of Marketing Authorisation Holders (MAHs) to participate based on readiness and alignment with defined pilot scenarios.
Key Highlights:- Environment: Submissions will be processed in EMA’s Test Environment (not the EMA Gateway).
- Validation: A first draft of validation criteria will be published soon, but initial submissions will not undergo standard validation.
- Scenario 1 – Initial MAA (sequence 1): EMA will prioritise processing for MAHs who can resubmit sequence 1 for an existing or previously authorised CAP (initially created in eCTD 3.2.2, sequence 0000), now re-created or converted (fully or partially) in eCTD v4.0.
- Scenario 2 – Initial MAA (sequence 1) for a Duplicate product: The duplicate can be a mock product to support early testing of Grouped submissions functionality, planned for Step 3.
- Scenario 3 – Validation responses (starting with sequence 2): Includes responses to validation outcomes.
- Scenario 4 – Post-authorisation activities: Involves various procedure types and multiple sequences related to products submitted in sequence 1.
Note: Step 2 will not focus on Grouped Submissions or Forward Compatibility — these are planned for Step 3.
At Masuu Global, we actively support regulatory advancements like the EMA’s eCTD v4.0 Technical Pilot. As regulatory landscapes evolve, early participation in initiatives such as this enables Marketing Authorisation Holders (MAHs) to align their processes with future eSubmission requirements. Our team is equipped to assist clients in preparing compliant eCTD v4.0 submissions, including sequence conversions and validation readiness. With Step 2 focusing on real-world scenarios for CAPs, it’s an ideal opportunity to gain hands-on experience ahead of full implementation. Masuu Global remains committed to guiding pharmaceutical partners through regulatory innovation with confidence and efficiency.