Class waivers

The need for a paediatric development may be waived for classes of medicines that are likely unsafe or ineffective in children, that lack benefit for paediatric patients or are for diseases and conditions that only affect the adult population. This page lists the class waivers granted by the European Medicines Agency (EMA).

The requirement to submit a paediatric investigation plan (PIP) is waived for specific medicines or classes of medicines 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 (PDCO) adopted a review of the class waiver list on 23 July 2015. The review included all previously granted class waivers, most of which referred to specific diseases. In its review, the PDCO took into account recent paediatric data concerning these diseases and medicines used for treating them. The PDCO assessed, for all class waivers, the available information on the disease area, the characteristics of the medicines and any available evidence on their possible use in children. It has revoked eight class waivers, updated 15 class waivers and confirmed nine class waivers in the current class waiver list.

• EMA decision on class waivers adopted on 23 July 2015

This decision contains an opinion with the updated list of waived conditions, and includes a summary report on the scientific discussion for the revision of the class waivers. It supersedes all previous class waiver decisions. Regulatory submissions will be subject to the revised list of class waivers from July 2018 onwards.

For regulatory submission until July 2018, the list of waived conditions included in the PDCO decision adopted on 19 December 2011 may be consulted:

• EMA decision on class waivers adopted on19 December 2011

All classes of medicines intended to treat these conditions are exempt from the requirement for a PIP until July 2018.

For more information and guidance, see:

• 'Request for confirmation of the applicability of the Agency decision on class waivers' on PIPs questions and answers page;
• Questions and answers on the EMA/PDCO review of the list of granted class waivers.

Short table of the EMA class waivers (this list may be used for regulatory submissions until July 2018*):

*An updated table with the revised EMA class waivers following the PDCO's decision on 23 July 2015 will be provided shortly.