European Medicines Agency - Human Medicines - Medicines for children - Class waivers

Medicines for children
Opinions and decisions on PIP applications
Class waivers
The requirement to submit a paediatric investigation plan shall be waived for specific medicinal products or classes of medicinal products that:

are likely to be ineffective or unsafe in part or all of the paediatric population;
are intended for conditions that occur only in adult populations;
do not represent a significant therapeutic benefit over existing treatments for paediatric patients.
In accordance with the Paediatric Regulation, the Paediatric Committee has adopted a list of conditions that occur only in adult populations. All classes of medicinal products intended to treat these conditions will therefore be exempt from the requirement for a paediatric investigation plan.

The consolidated EMEA decision on the list of class waivers, adopted on 26 October 2009 can be found here Updated on martes, 03 de noviembre de 2009. This decision replaces the previous decision, and includes the scientific grounds for the granting of a waiver. The EMEA decision on a class waiver, adopted on 8 September 2008, for a class of medicinal products in type 2 diabetes mellitus can be found here.

See also: Guidance on requests for a waiver corresponding to a condition listed in the list of class waivers adopted by the EMEA

Short table of EMEA Class Waivers:
Click on a column heading to sort alphabetically or by decision date

abrir aquí para acceder al documento EMEA completo:
European Medicines Agency - Human Medicines - Medicines for children - Class waivers