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 EMA/PDCO Summary Report on the review of the list of granted Class Waivers 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:
- PIPs questions and answers - Question 'Request for confirmation of the applicability of the Agency decision on class waivers'
- Questions and answers EMA/PDCO review of the list of granted Class Waivers
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 28 July 2018 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 |
| 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 |