Spring Intro 2023

30/03/2023

How and Where ? PIP Compliance Check

• Verification that some or all studies/measures in the agreed PIP have been completed in accordance with the PIP decision • Formal process conducted by PDCO (up to 60 days) • Required when submitting a • new MAA (if there are binding dates prior to the MAA submission – see below) • variation to change/add new indication, pharmaceutical form or route of administration • When is a compliance check not required? • When the initiation and/or completion of all studies/measures within the condition covered by the application have been deferred in the PIP decision and none of the dates falls before the date of submission of the Regulatory Application • If the applicant is not compliant with the PIP, this will prevent the submission of new MAAs and variations (as outlined above) and may be subject to financial penalties

The Organisation for Professionals in Regulatory Affairs

49

Who – Internal ?

CMC and Formulation Development • Paediatric formulations (small tablets, granules, suspensions etc) Nonclinical • Juvenile toxicology studies Clinical pharmacology • Bioequivalence studies • Pharmacokinetic modelling Clinical Research and Clinical Operations • Defining the paediatric indication/ area of study • Study design and operationalising US regulatory • Often a need to educate US colleagues on the importance of a timely filing Top tip – This is a high resource activity – Teams must be aware

The Organisation for Professionals in Regulatory Affairs

50