The European Medicines Agency is developing an inventory of the needs for paediatric medicines, to help medicinal-product developers identify opportunities.
In addition to its benefits for industry, the inventory aims to enable:
- the Paediatric Committee (PDCO) to judge the need for medicines and studies when assessing draft paediatric investigation plans, waivers and deferrals;
- healthcare professionals and patients to have an information source available to support their decisions as to which medicines to choose.
The need for the inventory stems from a report adopted by the PDCO in December 2010, on the survey of all paediatric uses of medicines in Europe:
- Report on the survey of all paediatric uses of medicinal products in Europe: Executive summary
- Report on the survey of all paediatric uses of medicinal products in Europe: Questions and answers
- Report on the survey of all paediatric uses of medicinal products in Europe
The Agency is publishing lists of medicines by therapeutic class one by one in the tables below. Each list is open for comments for two months after publication.
This project builds on an earlier exercise to establish paediatric needs, which the former Paediatric Working Party carried out between 2001 and 2007. The outcome of this exercise is also included in the tables below. This earlier exercise was conducted according to the EMEA/PEG Procedure for identifying paediatric needs.
Off-label use in children
The Agency has also produced a report on the off-label use of medicines in children. This explains that off-label use is associated with more adverse reactions to medicines for children and that adverse reactions in children may be more severe or different from what is known in adults.
Anaesthesiology
Assessment of the paediatric needs - Anaesthesiology
Cardiovascular
Inventory of paediatric medicines - Cardiovascular therapeutic area
Draft inventory of paediatric medicines - Cardiovascular therapeutic area
Assessment of the paediatric needs - Cardiovascular products
Overview of comments received on list of paediatric needs – Cardiovascular products
Diabetes (types I and II)
Assessment of the paediatric needs - Diabetes (types I and II)
Endocrinology
Inventory of paediatric therapeutic needs - Endocrinology
Draft inventory of paediatric therapeutic needs - Endocrinology
Overview of comments received on the list of paediatric needs – Endocrinology
Gastroenterology
Inventory of paediatric therapeutic needs: gastroenterology
Response to public comments received on the inventory of paediatric therapeutic needs: gastroenterology
Inventory of paediatric therapeutic needs - Gastroenterology
Assessment of the paediatric needs - Gastroenterology
Infectious diseases
Inventory of paediatric therapeutic needs - Infectious diseases
Draft inventory of paediatric medicines - Infectious diseases
Assessment of the paediatric needs - Anti-infectious therapy with focus on antimycotics, antivirals (except HIV)
Neurology
Draft inventory of paediatric therapeutic needs - Neurology
Assessment of the paediatric needs - Epilepsy
Overview of comments received on list of paediatric needs - Epilepsy
Assessment of the paediatric needs - Migraine
Obstructive lung disease
Assessment of the paediatric needs - Asthma and other obstructive chronic lung diseases
Oncology
Draft inventory of paediatric therapeutic needs: Paediatric oncology
Assessment of the paediatric needs - Chemotherapy products (part I)
Overview of comments received on list of paediatric needs - Oncology I (cytotoxic therapy)
Assessment of the paediatric needs - Chemotherapy products (part II)
Pain
Assessment of the paediatric needs - Pain
Psychiatry
Assessment of the paediatric needs - Psychiatry
Respiratory
Inventory of paediatric therapeutic needs - Respiratory
Response to public comments received on the ‘Inventory of paediatric therapeutic needs – Respiratory’
Draft inventory of paediatric therapeutic needs - Respiratory