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Pre-authorisation Evaluation of Medicines for Human Use REVISED PRIORITY LIST FOR STUDIES INTO
OFF-PATENT PAEDIATRIC MEDICINAL PRODUCTS
NOTE and DISCLAIMER
The list includes only products considered to be off-patent, i.e. not covered by a basic patent or a
supplementary protection certificate. It should be noted that information on the authorisation status as
well as on available paediatric formulations of medicinal products is very limited and not available for all
European Member States. Information on the off-patent and authorisation status is not guaranteed by
EMEA. Users of this list are therefore advised to check the patent status and the authorisation status of
the medicinal products of interest.
The methodology used to establish the list was based as much as possible on evidenced-based medicine.
It is however acknowledged that identification of priorities for research into medicinal products for
paediatric use is partly based on subjective criteria and that identified priorities may change over time.
OBJECTIVE OF THE LIST:
The aim of Regulation (EC) No1901/2006 of the European Parliament and the Council on Medicinal Products for Paediatric Use, as amended, is to increase availability of medicines authorised for children as well as to increase the information available on the use of medicinal products in the paediatric population. The Regulation includes provisions for funding of studies into off-patent medicinal products. This funding, currently provided through the EU Framework Programmes, should cover the development of off-patent medicinal products with a view to the submission of a Paediatric Use Marketing Authorisation (PUMA)). The agreement on the specific content of a PUMA application will eventually be through a Paediatric Investigation Plan (PIP). The revision of the priority list provides the basis for the Fourth Call of the 7th Framework Programme of the European Commission. It ensures that funds are directed into research of medicinal products with the highest needs in the paediatric population. The following list of off-patent products has been revised by the Paediatric Committee (PDCO) and was agreed on 03/07/2009. 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 40 E-mail: mail@emea.europa.eu http://www.emea.europa.eu European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged. The products are listed according to their therapeutic field and condition(s) in alphabetical order.
Age-appropriate formulations (even if not stated explicitly for a product) and data in neonates
(except for oncology) are considered to be of high priority.

Therapeutic field
Product Condition(s)
Specific

Cardiology

* Please note that there is a need for international consensus on the definition of 'shock' in neonates, and
any medicine development should take this into consideration.
Child & adolescent
psychiatry

disorder (MDD) with
Dermatology

Endocrinology

Data on efficacy and safety in children from 6 years. Palatable formulation. Age-appropriate oral formulation; age group 0-2 years. Therapeutic field
Product Condition(s)
Specific
Gastroenterology
Data on long-term efficacy, safety, all age groups; age-appropriate formulation. Data on long-term efficacy, safety, all age groups. Haematology
Data on PK, efficacy and safety; age from 2 years to less than 10 years. Immunology
(refer also to oncology, gastroenterology and rheumatology) Severe atopic dermatitis Data on efficacy and transplantation (HSCT) for various conditions. Therapeutic field
Product Condition(s)
Specific
childhood scleroderma, JIA-related uveitis Infections
Data on efficacy and safety in immuno-compromised patients in all age groups, including neonates and preterm infants. caused by mycoplasma, bordetella pertussis, ureaplasma. Data on PK, efficacy and safety in immuno-compromised patients in all age groups, neonates, and preterm infants. Therapeutic field
Product Condition(s)
Specific
infections, aspergillosis, safety. chronic granulomatous disease, febrile neutropenia. Intensive
(refer also other fields such as cardiology, haematology, infections, neonatology care/anaesthesiology
Data on PK, efficacy and safety. Age-appropriate formulations including oral formulation. Data on PK, efficacy and safety; age-appropriate formulations (rectal, intravenous); age group 0-6 months. Short-term sedation,
Metabolism
Neonatology
(refer also other fields such as cardiology, infections, intensive care/anaesthesiology, neurology, pain) Data on efficacy and safety in neonates. Nephrology/urology
Therapeutic field
Product Condition(s)
Specific

ramipril
Neurology
allopurinol Cerebral Proof of concept – if this is Data on PK, efficacy and safety for intravenous formulation. Oncology
Data in infants are considered of high priority.
(refer also to immunology)
Germ-cell tumours, Ewing sarcoma, retinoblastoma, soft-tissue sarc neuroblastoma, Hodgkin lymphoma, non-Hodgkin lymphoma, acute lymphoblastic leukaemia Therapeutic field
Product Condition(s)
Specific
Data on PK, efficacy and safety. Age appropriate formulations. Pneumology
(refer also to infections, immunology, intensive care) Data on PK, anti-
inflammator efficacy,
safety; all paediatric age
groups.
Rheumatology
METHODOLOGY

The original list 2003 had been prepared from a public health perspective prioritising in a first step
conditions based on factors such as severity of disease, non-availability of treatment alternatives, affected
paediatric age groups and paediatric prevalence data. In a second step for each condition medicinal off-
patent products were identified according to published therapeutic reviews.
For the revision in 2008 medicinal products were prioritised also taking into account the WHO list of
essential medicines for children, the FDA/NICHD list of products and further paediatric needs. Potential
collaboration with FDA/NICHD has been taken into consideration with a view to avoid duplication of
efforts.
The latest revision in 2009 took into account the projects which have been funded in the previous calls as
well as comments and proposals from learned scientific and paediatric Societies, following a wide call for
expression of interest.

Source: http://www.siope.eu/wp-content/uploads/2013/09/EMEA_Off-patent_list_2009.pdf

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