Class waivers

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 paediatric investigation plan 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 an opinion on a class waiver on conditions in May 2025, in accordance with the Paediatric Regulation.

This decision contains the updated list of classes of medicines. It supersedes and replaces the previous class waiver decisions.

European Medicines Agency decision CW/0001/2025 of 2 June 2025 on class waivers in accordance with Regulation EC No 1901-2006 of the European Parliament and of the Council

Reference Number: EMADOC-1700519818-2155553

EMA/PDCO summary report on the review of the list of granted Class Waivers 2 June 2025

Reference Number: EMADOC-1700519818-2008871

For more information and guidance, see:

• Paediatric medicines: applications and procedures: Procedural advice on paediatric applications

List of waived classes of medicines

The table below contains the updated waived classes of medicines for the listed conditions. Regulatory submissions are subject to this list from 2 June 2025 onwards.

Class of medicines	Condition
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 products	Breast malignant neoplasms, prostate malignant neoplasms and neuroendocrine malignant neoplasms
First-generation taxoid medicinal products	Breast 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 products	Gynaecological epithelial malignant neoplasms
Her- / epidermal growth factor-receptor antibody medicinal products	Breast malignant neoplasms, intestinal malignant neoplasms and head and neck epithelial malignant neoplasms
Thymidylate synthase inhibitor medicinal products	Intestinal malignant neoplasms and lung malignant neoplasms
Colchicum alkaloids (colchicine and its derivatives) medicinal products	Primary gout
Androgen antagonist medicinal products	Benign prostatic hyperplasia
Pyrimidine- and pyrimidine analogue-containing medicinal products	Breast 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 products	Urinary tract malignant neoplasms, head and neck epithelial malignant neoplasms and lung malignant neoplasms
Alkylating-methylating medicinal products	Skin malignant neoplasms
Ribonucleotide reductase-beta-2 inhibitor medicinal products	Myeloproliferative neoplasms
Primarily alkylating medicinal products	Myeloproliferative neoplasms and mature B, T and NK cell neoplasms
Photosensitising medicinal products	Head and neck epithelial malignant neoplasms
Retinoic X receptor-activating medicinal products	Mature B, T and NK cell neoplasms
Immunomodulatory cytokine medicinal products	Neuroendocrine malignant neoplasms, skin malignant neoplasms, myeloproliferative neoplasms and mature B, T and NK cell neoplasms
All classes of medicinal products (NEW)	Diagnosis of IgE-mediated allergy
Peroxisome proliferator-activated receptor (PPAR)-gamma modulators, including dual and multiple PPAR modulator (e.g., thiazolidinediones, glitazars, triple modulators) medicinal products	Type II diabetes mellitus
All classes of medicinal products	Primary and secondary osteoarthrosis
All classes of medicinal products	Organic amnestic syndrome (excluding amnestic syndrome caused by alcohol and other psychoactive substances)
All classes of medicinal products	Age-related macular degeneration and diabetic macular oedema
All classes of medicinal products	Climacteric symptoms associated with decreased oestrogen levels, as occurring at menopause
All classes of medicinal products	Alzheimer's disease
All classes of medicinal products	Erectile dysfunction
All classes of medicinal products	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)
All classes of medicinal products	Vulvar intraepithelial neoplasia

 

Contact points

To contact EMA, please see the options listed on below:

• Paediatric medicines: Research and development: Contact points