EMA Updates Pediatric Investigation Plan Reexamination Procedure

Drugmakers should notify the European Medicines Agency within 10 days of receiving an initial opinion on a pediatric investigation plan if they plan to request another review.

The official request, due 20 days later, should include the procedure number and a detailed justification for requesting the reexamination, according to updated guidance issued last week.

Sponsors should base their requests only on the information provided in the original application, the EMA says. New analyses of the same data will be considered, as will compromise proposals, such as minor protocol amendments to a previously proposed study, but the agency won’t accept significant changes to the pediatric investigation plan.

The agency prefers that requests be submitted via the eSubmissions gateway, but will accept them on CD or DVD if necessary, the guideline says.

Once a request for reexamination is received, the EMA’s Pediatric Committee will appoint a rapporteur to review the initial decision and contact the sponsor with any questions. The rapporteur is required to maintain a record of these contacts.

The EMA promises to return a final response within 30 days, along with a detailed rationale for that decision.

The agency provided guidance on submitting pediatric investigation plans, including comparative analyses of pediatric and adult pharmacodynamics and dosing and age range specifications, last fall. A question-and-answer document outlining how to go about compliance checks for PIP submissions was also released last week.

View the updated guideline at www.fdanews.com/01-22-15-newguideline.pdf. The Q&A document is at www.fdanews.com/01-22-15-QandA.pdf. — Lena Freund