Friday, January 8, 2010

PIP EU - Pediatric Investigational Plan - Clinical/Regulatory Submission

Due to recent legislation in the EU governing the development and authorization of medicines for use in children, a PIP now needs to be written and an opinion adopted, prior to clinical/regulatory submission of a MAA - Marketing Authorization Application.

The preparation of a PIP presents the unique challenge of concisely presenting information on the disease to be treated in children and current knowledge of the drug being developed, together with assembling a convincing rationale for the pediatric development program being proposed.

PIPs can be developed, prepared and submitted in most therapeutic areas, applicable to pediatrics.

In several ways, the PIP is more complicated than most clinical/regulatory submissions. Therefore, it is strongly advised that all pharma sponsor functions be proactively involved. Literature based information, post-marketing information, safety surveillance information and otherwise as well as previously submitted and approved filing for the adult in all indications, if applicable, are readily available to the writing and QC teams at development start of the PIP.

Acceptance and use of the PIP clinical/regulatory submission in the EU is in its first year and I believe just in the recent past, the first approval was awarded, so the SOPs, the structure and content are still under scrutiny and is currently monitored and reviewed with rigor.

From the Desk of Dante and Dante Colleagues.

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