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*):
|Condition / Class of medicines||Decision date|
|Treatment of adenocarcinoma of the colon and rectum||21/04/2008|
|Treatment of adenocarcinoma of the pancreas||21/04/2008|
|Treatment of age-related macular degeneration||03/12/2007|
|Treatment of Alzheimer’s disease||03/12/2007|
|Treatment of amyotrophic lateral sclerosis||03/12/2007|
|Treatment of basal cell carcinoma||03/12/2007|
|Treatment of benign prostatic hyperplasia||21/04/2008|
|Treatment of breast carcinoma||03/12/2007|
|Treatment of cervix and corpus uteri carcinoma||21/04/2008|
|Treatment of chronic lymphocytic leukaemia||21/04/2008|
|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 menopause||03/04/2009|
|Treatment of coronary atherosclerosis||21/04/2008|
|Treatment of endometrial carcinoma||03/12/2007|
|Treatment of erectile dysfunction||21/04/2008|
|Treatment of fallopian tube carcinoma (excluding rhabdomyosarcoma and germ cell tumours)||26/10/2009|
|Treatment of follicular lymphoma||21/04/2008|
|Treatment of gastric adenocarcinoma||21/04/2008|
|Treatment of gastric carcinoids||21/04/2008|
|Treatment of gastroenteropancreatic neuroendocrine tumours (excluding neuroblastoma, neuroganglioblastoma, phaeochromocytoma)||26/10/2009|
|Treatment of hairy cell leukaemia||03/12/2007|
|Treatment of Huntington chorea||21/04/2008|
|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 myelofibrosis||20/12/2010|
|Treatment of diabetic macular oedema||20/12/2010|
|Treatment of mesothelioma||20/12/2010|
|Treatment of actinic keratosis||20/12/2010|
Treatment of melanoma (from 12 to less than 18 years old)
Treatment of menopausal and other perimenopausal disorders
** 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.
|Treatment of multiple myeloma||03/12/2007|
|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 atherosclerosis||21/04/2008|
|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 osteoarthrosis||26/04/2010|
|Treatment of prostate carcinoma (excluding rhabdomyosarcoma)||03/12/2007|
|Treatment of ureter and bladder carcinoma||26/10/2009|
|Treatment of vaginal and vulvar carcinoma (excluding rhabdomyosarcoma and soft tissue sarcoma)||26/10/2009|
|Treatment of vascular dementia and vascular cognitive disorder/impairment||03/12/2007|
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)
*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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- European Medicines Agency decision CW-0001-2015 of 23 July 2015 on class waivers in accordance with Regulation EC No 1901-2006 of the European Parliament and of the Council (23/07/2015)
- EMA/PDCO Summary Report on the review of the list of granted Class Waivers (23/07/2015)
- Questions and answers EMA/PDCO review of the list of granted Class Waivers (23/07/2015)