Needs for paediatric medicines

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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 European Medicines Agency / Paediatric Working Party 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.

Table of contents


Anaesthesiology

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Document(s) Language Status First published Last updated Effective Date
Assessment of the paediatric needs - Anaesthesiology (English only) adopted 2006-10-01    

Cardiovascular

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Document(s) Language Status First published Last updated Effective Date
Inventory of paediatric medicines - Cardiovascular therapeutic area (English only) adopted 2013-04-25   2012-12-07
Draft inventory of paediatric medicines - Cardiovascular therapeutic area (English only) draft: consultation closed 2012-08-30    
Assessment of the paediatric needs - Cardiovascular products (English only) adopted 2006-10-01    
Overview of comments received on list of paediatric needs – Cardiovascular products (English only)   2006-10-10    

Diabetes (types I and II)

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Document(s) Language Status First published Last updated Effective Date
Assessment of the paediatric needs - Diabetes (types I and II) (English only) adopted 2008-07-04    

Endocrinology

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Document(s) Language Status First published Last updated Effective Date
Inventory of paediatric therapeutic needs - Endocrinology (English only) adopted 2015-08-19    
Draft inventory of paediatric therapeutic needs - Endocrinology (English only) draft: consultation closed 2015-05-11 2015-06-01  
Overview of comments received on the list of paediatric needs – Endocrinology (English only)   2015-08-19    

Gastroenterology

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Document(s) Language Status First published Last updated Effective Date
Inventory of paediatric therapeutic needs: gastroenterology (English only) adopted 2015-10-28    
Response to public comments received on the inventory of paediatric therapeutic needs: gastroenterology (English only)   2015-10-28    
Inventory of paediatric therapeutic needs - Gastroenterology (English only) draft: consultation closed 2015-05-11 2015-06-01  
Assessment of the paediatric needs - Gastroenterology (English only) adopted 2007-10-01    

Immunology

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Document(s) Language Status First published Last updated Effective Date
Assessment of the paediatric needs - Immunology (English only) adopted 2006-09-01    
Overview of comments received on list of paediatric needs - Immunology (English only)   2006-09-25    

Infectious diseases

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Document(s) Language Status First published Last updated Effective Date
Inventory of paediatric therapeutic needs - Infectious diseases (English only) adopted 2014-05-08   2013-10-11
Draft inventory of paediatric medicines - Infectious diseases (English only) draft: consultation closed 2013-05-15 2013-06-18  
Assessment of the paediatric needs - Anti-infectious therapy with focus on antimycotics, antivirals (except HIV) (English only) adopted 2006-10-01    

Nephro-urology

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Document(s) Language Status First published Last updated Effective Date
Inventory of paediatric therapeutic needs - Nephro-urology (English only)   2014-09-12    
Draft inventory of paediatric therapeutic needs - Nephro-urology (English only) draft: consultation closed 2013-08-12    
Assessment of the paediatric needs - Nephrology (English only) adopted 2006-12-01    

Neurology

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Document(s) Language Status First published Last updated Effective Date
Draft inventory of paediatric therapeutic needs - Neurology (English only) draft: consultation closed 2014-05-08    
Assessment of the paediatric needs - Epilepsy (English only) adopted 2006-09-20    
Overview of comments received on list of paediatric needs - Epilepsy (English only)   2006-09-21    
Assessment of the paediatric needs - Migraine (English only)   2006-06-02    

Obstructive lung disease

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Document(s) Language Status First published Last updated Effective Date
Assessment of the paediatric needs - Asthma and other obstructive chronic lung diseases (English only) adopted 2006-10-01    

Oncology

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Document(s) Language Status First published Last updated Effective Date
Draft inventory of paediatric therapeutic needs: Paediatric oncology (English only) draft: consultation closed 2014-10-08    
Assessment of the paediatric needs - Chemotherapy products (part I) (English only) adopted 2006-09-01    
Overview of comments received on list of paediatric needs - Oncology I (cytotoxic therapy) (English only)   2006-09-01    
Assessment of the paediatric needs - Chemotherapy products (part II) (English only) adopted 2006-06-02    

Ophthalmology

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Document(s) Language Status First published Last updated Effective Date
Inventory of paediatric therapeutic needs - Ophthalmology (English only)   2014-09-12    
Draft inventory of paediatric therapeutic needs - Ophthalmology (English only) draft: consultation closed 2014-05-08    

Pain

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Document(s) Language Status First published Last updated Effective Date
Assessment of the paediatric needs - Pain (English only) adopted 2005-06-23    

Psychiatry

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Document(s) Language Status First published Last updated Effective Date
Assessment of the paediatric needs - Psychiatry (English only) adopted 2007-07-27    

Respiratory

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Document(s) Language Status First published Last updated Effective Date
Inventory of paediatric therapeutic needs - Respiratory (English only) adopted 2016-10-07    
Response to public comments received on the ‘Inventory of paediatric therapeutic needs – Respiratory’ (English only)   2016-10-07    
Draft inventory of paediatric therapeutic needs - Respiratory (English only) draft: consultation closed 2016-05-11    

Rheumatology

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Document(s) Language Status First published Last updated Effective Date
Assessment of the paediatric needs - Rheumatology (English only) adopted 2006-06-02    
Overview of comments received on list on paediatric needs on rheumatology (English only)   2006-06-02