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 EMA decision on the list of class waivers, adopted on 26 April 2010 can be found here Updated on viernes, 30 de abril de 2010. 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: open here please
European Medicines Agency - Human Medicines - Medicines for children - Class waivers

Contents:
Adenocarcinoma of the colon and rectum 21/04/2008
Adenocarcinoma of the pancreas 21/04/2008
Age-related macular degeneration 03/12/2007
Alzheimer’s disease 03/12/2007
Amyotrophic lateral sclerosis 03/12/2007
Basal cell carcinoma 03/12/2007
Benign prostatic hyperplasia 21/04/2008
Breast carcinoma 03/12/2007
Cervix and corpus uteri carcinoma 21/04/2008
Chronic lymphocytic leukaemia 21/04/2008
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
Climacteric symptoms associated with decreased oestrogen levels, as occurring at menopause 03/04/2009
Coronary atherosclerosis 21/04/2008
Endometrial carcinoma 03/12/2007
Erectile dysfunction 21/04/2008
Fallopian tube carcinoma (excluding rhabdomyosarcoma and germ cell tumours) 26/10/2009
Follicular lymphoma 21/04/2008
Gastric adenocarcinoma 21/04/2008
Gastric carcinoids 21/04/2008
Gastroenteropancreatic neuroendocrine tumours (excluding neuroblastoma, neuroganglioblastoma, phaeochromocytoma) 26/10/2009
Hairy cell leukaemia 03/12/2007
Huntington chorea 21/04/2008
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
Liver and intrahepatic bile duct carcinoma (excluding hepatoblastoma) 21/04/2008
Lung carcinoma (small cell and non-small cell carcinoma) 03/12/2007
Melanoma (from 0 to less than 12 years old) 03/12/2007
Melanoma (from 12 to less than 18 years old)
* 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 EMEA decision for the grounds. 03/12/2007 Revoked 14/07/2008*

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 EMEA decision for the grounds. 03/12/2007 Revoked 13/04/2009**

Multiple myeloma 03/12/2007
Organic amnesic syndrome (excluding amnesic syndrome caused by alcohol and other psychoactive substances) 03/12/2007
Oropharyngeal, laryngeal or nasal epithelial carcinoma (excluding nasopharyngeal carcinoma or lymphoepithelioma) 26/10/2009
Ovarian carcinoma (excluding rhabdomyosarcoma and germ cell tumours) 03/12/2007
Parkinson’s disease (non-juvenile) 03/12/2007
Peripheral atherosclerosis 21/04/2008
Peritonea carcinoma (excluding blastomas and sarcomas) 26/10/2009
Primary gout (excluding Lesch-Nyhan syndrome and other secondary forms of gout) 21/04/2008

Treatment of primary and secondary osteoarthrosis 26/04/2010
Prostate carcinoma (excluding rhabdomyosarcoma) 03/12/2007
Ureter and bladder carcinoma 26/10/2009
Vaginal and vulvar carcinoma (excluding rhabdomyosarcoma and soft tissue sarcoma) 26/10/2009

Vascular dementia and vascular cognitive disorder/impairment 03/12/2007
Peroxisome proliferator-activated receptor (PPAR)-gamma modulators, including dual and multiple PPAR modulators (e.g., thiazolidinediones, glitazars, triple modulators) Type II diabetes mellitus