Class waivers

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The European Medicines Agency (EMA) maintains a list of class waivers for medicines that are not required to submit a paediatric investigation plan (PIP) as part of a marketing authorisation application. These medicines are likely unsafe or ineffective in children, lack benefit for children or are for diseases and conditions that only affect the adult population.

The requirement to submit a 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.

The Paediatric Committee (PDCO) adopted a review of class waiver list in July 2015, in accordance with the Paediatric Regulation,

This review contains the updated list of classes of medicines and includes a summary report on the scientific discussion for the revision of the class waivers. It supersedes all previous class waiver decisions. 

Marketing authorisation applications submitted from 28 July 2018 onwards will be subject to the revised list of class waivers.

For more information and guidance, see:

Marketing authorisation applications until July 2018

Please note that for marketing authorisation applications until 27 July 2018, the list of waived conditions included in the PDCO decision adopted in 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.

List of waived classes of medicines (updated)

The table below contains the updated waived classes of medicines for the listed conditions. Regulatory submissions are subject to this list from 28 July 2018 onwards.

Class of medicinesCondition
Androgen receptor modulator, of oestrogen receptor modulator, of growth and sex hormone as well as their releasing or inhibiting factors, and of sex hormone-metabolism modulator medicinal productsBreast malignant neoplasms, prostate malignant neoplasms and neuroendocrine malignant neoplasms
First-generation taxoid medicinal productsBreast malignant neoplasms, gynaecological epithelial malignant neoplasms, prostate malignant neoplasms, intestinal malignant neoplasms, pancreatic malignant neoplasms, head and neck epithelial malignant neoplasms as well as lung malignant neoplasms
Ecteinascidin medicinal productsGynaecological epithelial malignant neoplasms
Her- / epidermal growth factor-receptor antibody medicinal productsBreast malignant neoplasms, intestinal malignant neoplasms and head and neck epithelial malignant neoplasms
Thymidylate synthase inhibitor medicinal productsIntestinal malignant neoplasms and lung malignant neoplasms
Colchicum alkaloids (colchicine and its derivatives) medicinal productsPrimary gout
Androgen antagonist medicinal productsBenign prostatic hyperplasia
Pyrimidine- and pyrimidine analogue-containing medicinal productsBreast malignant neoplasms, intestinal malignant neoplasms, lung malignant neoplasms, pancreatic malignant neoplasms, head and neck epithelial malignant neoplasms, skin malignant neoplasms and actinic keratosis
First- and second-generation platinum-containing medicinal productsUrinary tract malignant neoplasms, head and neck epithelial malignant neoplasms and lung malignant neoplasms
Alkylating-methylating medicinal productsSkin malignant neoplasms
Ribonucleotide reductase-beta-2 inhibitor medicinal productsMyeloproliferative neoplasms
Primarily alkylating medicinal productsMyeloproliferative neoplasms and mature B, T and NK cell neoplasms
Photosensitising medicinal productsHead and neck epithelial malignant neoplasms
Retinoic X receptor-activating medicinal productsMature B, T and NK cell neoplasms
Immunomodulatory cytokine medicinal productsNeuroendocrine malignant neoplasms, skin malignant neoplasms, myeloproliferative neoplasms and mature B, T and NK cell neoplasms
Peroxisome proliferator-activated receptor (PPAR)-gamma modulators, including dual and multiple PPAR modulator (e.g., thiazolidinediones, glitazars, triple modulators) medicinal productsType II diabetes mellitus
All classes of medicinal productsPrimary and secondary osteoarthrosis
All classes of medicinal productsOrganic amnestic syndrome (excluding amnestic syndrome caused by alcohol and other psychoactive substances)
All classes of medicinal productsAge-related macular degeneration and diabetic macular oedema
All classes of medicinal productsClimacteric symptoms associated with decreased oestrogen levels, as occurring at menopause
All classes of medicinal productsAlzheimer’s disease
All classes of medicinal productsErectile dysfunction
All classes of medicinal productsChronic 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)
All classes of medicinal productsVulvar intraepithelial neoplasia

 

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paediatrics@ema.europa.eu