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:

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

Immunology

Assessment of the paediatric needs - Immunology

Overview of comments received on list of paediatric needs - Immunology

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)

Nephro-urology

Inventory of paediatric therapeutic needs - Nephro-urology

Draft inventory of paediatric therapeutic needs - Nephro-urology

Assessment of the paediatric needs - Nephrology

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)

Ophthalmology

Inventory of paediatric therapeutic needs - Ophthalmology

Draft inventory of paediatric therapeutic needs - Ophthalmology

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

Rheumatology

Assessment of the paediatric needs - Rheumatology

Overview of comments received on list on paediatric needs on rheumatology

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