Class waivers

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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.

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:

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:

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

Condition / Class of medicinesDecision date
Treatment of adenocarcinoma of the colon and rectum21/04/2008
Treatment of adenocarcinoma of the pancreas21/04/2008
Treatment of age-related macular degeneration03/12/2007
Treatment of Alzheimer’s disease03/12/2007
Treatment of amyotrophic lateral sclerosis03/12/2007
Treatment of basal cell carcinoma03/12/2007
Treatment of benign prostatic hyperplasia21/04/2008
Treatment of breast carcinoma03/12/2007
Treatment of cervix and corpus uteri carcinoma21/04/2008
Treatment of chronic lymphocytic leukaemia21/04/2008
Treatment of chronic obstructive pulmonary disease (COPD) (excluding chronic lung diseases associated with long-term airflow limitation, such as asthma, bronchopulmonary dysplasia, primary cilia dyskinesia, obstructive lung disease related to graft-versus-host disease after (bone-marrow) transplantation).03/12/2007
Treatment of climacteric symptoms associated with decreased oestrogen levels, as occurring at menopause03/04/2009
Treatment of coronary atherosclerosis21/04/2008
Treatment of endometrial carcinoma03/12/2007
Treatment of erectile dysfunction21/04/2008
Treatment of fallopian tube carcinoma (excluding rhabdomyosarcoma and germ cell tumours)26/10/2009
Treatment of follicular lymphoma21/04/2008
Treatment of gastric adenocarcinoma21/04/2008
Treatment of gastric carcinoids21/04/2008
Treatment of gastroenteropancreatic neuroendocrine tumours (excluding neuroblastoma, neuroganglioblastoma, phaeochromocytoma)26/10/2009
Treatment of hairy cell leukaemia03/12/2007
Treatment of Huntington chorea21/04/2008
Treatment of kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney)21/04/2008
Treatment of liver and intrahepatic bile duct carcinoma (excluding hepatoblastoma)21/04/2008
Treatment of lung carcinoma (small cell and non-small cell carcinoma)03/12/2007
Treatment of melanoma (from 0 to less than 12 years old)03/12/2007
Treatment of primary myelofibrosis20/12/2010
Treatment of diabetic macular oedema20/12/2010
Treatment of mesothelioma20/12/2010
Treatment of actinic keratosis20/12/2010

Treatment of melanoma (from 12 to less than 18 years old)
(Revoked 14/07/2008*)

* The requirements of art. 7 and art. 8 of Regulation (EC) No 1901/2006 shall not apply to 12 to less than 18 years old children, until 14 July 2011. Please check the EMA decision for the grounds.

03/12/2007

Treatment of menopausal and other perimenopausal disorders
(Revoked 13/04/2009**)

** The requirements of art. 7 and art. 8 of Regulation (EC) No 1901/2006 shall not apply to “treatment of menopausal and other perimenopausal disorders” to all subsets of the paediatric population until 15 April 2012. Please check the EMA decision for the grounds.

03/12/2007
 
Treatment of multiple myeloma03/12/2007
Treatment of organic amnesic syndrome (excluding amnesic syndrome caused by alcohol and other psychoactive substances)03/12/2007
Treatment of oropharyngeal, laryngeal or nasal epithelial carcinoma (excluding nasopharyngeal carcinoma or lymphoepithelioma)26/10/2009
Treatment of ovarian carcinoma (excluding rhabdomyosarcoma and germ cell tumours)03/12/2007
Treatment of Parkinson’s disease (non-juvenile)03/12/2007
Treatment of peripheral atherosclerosis21/04/2008
Treatment of peritoneal carcinoma (excluding blastomas and sarcomas)26/10/2009
Treatment of primary gout (excluding Lesch-Nyhan syndrome and other secondary forms of gout)21/04/2008
Treatment of primary osteoarthrosis (excluding secondary osteoarthrosis)21/04/2008
Treatment of primary and secondary osteoarthrosis26/04/2010
Treatment of prostate carcinoma (excluding rhabdomyosarcoma)03/12/2007
Treatment of ureter and bladder carcinoma26/10/2009
Treatment of vaginal and vulvar carcinoma (excluding rhabdomyosarcoma and soft tissue sarcoma)26/10/2009
Treatment of vascular dementia and vascular cognitive disorder/impairment03/12/2007

Treatment of type II diabetes mellitus:

Peroxisome proliferator-activated receptor (PPAR)-gamma modulators, including dual and multiple PPAR modulators (e.g., thiazolidinediones, glitazars, triple modulators)

08/09/2008

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

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paediatrics@ema.europa.eu