Historically (and still referenced in many older documents and systems like EudraCT), the final EMA decision on a Paediatric Investigation Plan (PIP) was commonly identified by a short “P reference number” in the format P/xxx/yyyy (or sometimes P/xx/yyyy), where:
- “P” indicates a positive/agreed PIP decision (other codes like RP for refused, PM for modification granted, W for waiver, etc.).
- “xxx” is a sequential number (1–3 digits).
- “yyyy” is the year of the decision.
This short “P/…” code appeared prominently on the title page of the EMA’s PIP decision letter/document, and it was (and often still is) the key identifier used in contexts like clinical trial applications (e.g., in EudraCT field A.8 for EMA Decision number of Paediatric Investigation Plan), marketing authorisation submissions, or cross-references.
However, in recent years (particularly post-Brexit and with procedural updates), EMA has shifted emphasis toward including the full paediatric procedure number (also called the paediatric procedure reference or core number) in the decision documents themselves. This full procedure number is typically in the format:
- EMEA-xxxxxx-PIPxx-yy (for initial PIPs/waivers, where xxxxxx is a 6-digit sequential number, xx is the sequential PIP for the substance, yy the year).
- Or variations like EMEA-xxxxxx-PIPxx-yy-Mxx for modifications.
This full procedure number is assigned early (upon receipt/acknowledgement of the submission) and is used throughout the procedure for all correspondence, document naming, and tracking. It appears in:
- Acknowledgement emails.
- PDCO opinions.
- Final EMA decisions (often in headers, footers, or as a primary reference alongside or instead of just the short P code).
- Public EMA databases/lists of opinions and decisions on PIPs.
Confirmation from Sources
- Older/legacy references (e.g., EudraCT guidance, some pre-2020 documents) highlight the P/xxx/yyyy format as the “EMA PIP decision number.”
- More recent procedural guidance (e.g., EMA’s “Guidance on paediatric submissions” documents from around 2017–2021, still referenced) stresses the full EMEA-…-PIPxx-yy format for document naming, validation, and all procedural steps.
- In public EMA PIP search results and decision publications, both may appear, but the full procedure number is retained and prominent for traceability (especially for modifications, compliance checks, or linked procedures).
- UK MHRA guidance (post-Brexit, as of 2025 updates) still cross-references EU PIPs using the P/xxxx/yyyy format when citing legacy EMA decisions, but for new/ongoing, the full procedure context is key.
In summary:
EMA has not entirely abandoned the short P reference (it’s still used and valid for identifying positive PIP decisions), but they now routinely retain/include the full paediatric procedure number in the decision letter/document for consistency across the lifecycle. This shift makes sense for better tracking in complex or multi-procedure cases.