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. 2020 Dec 2;12(12):1176. doi: 10.3390/pharmaceutics12121176

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