Table 2.
The three documents produced by the EMA outlining paediatric medicinal needs as described at the EMA website [16,17]. * Therapeutic areas in the inventory are being published one by one with 9 currently available, the first list was published in 2013, a current example of such is shown in [18].
Document | Year | Purpose |
---|---|---|
Assessment of the paediatric needs (APN) | 2007 | To identify active substances which require further development and/or research in paediatrics. Includes off-patent and new substances. |
Off-patent priority list (OPPL) | 2013 | To identify priorities for development of off-patent products (INN) with the view of the developers submitting a PUMA. |
Inventory of paediatric medicines (IPM) | N/A * | To detail development priorities for active substances in order to help product developers choose where to direct research |