Submitting results of paediatric studies

Marketing authorisation holders must submit the results of studies on authorised medicines conducted in children to the European Medicines Agency (EMA) or to national competent authorities in the European Union (EU).
Human Regulatory and procedural guidance Paediatrics

Page updated on 1 October 2025 to include information on the Clinical Trials Information System (CTIS)

Submitting results of paediatric studies is a requirement of the Paediatric Regulation — from Articles 45 and 46.

All clinical trials in scope of these two articles, or included in an agreed paediatric investigation plan (PIP), are available via the following websites:

EMA is publishing this information in accordance with Article 41 of the Paediatric Regulation.

Find out more about paediatric medicines in post-authorisation:

Publishing results of paediatric studies under Article 45

Article 45 of the Paediatric Regulation requires marketing authorisation holders in the EU to submit information on all paediatric studies that had been completed by 26 January 2007. This was ahead of the regulation's entry into force, on 26 January 2008.

This applied to both centrally and nationally authorised medicines.

For nationally authorised medicines, assessment reports of Article 45 studies are available on the website of the Heads of Medicines Agencies (HMA).

For centrally authorised medicines, assessment reports of Article 45 studies are part of the European public assessment reports (EPARs).

Marketing authorisation holders were required to submit the results of studies in scope of Article 45 of the Paediatric Regulation by 2011. This information is available on the European Union Regulating Authorities Clinical Trials Database (EudraCT database). 

For more on the publication of the results of paediatric studies under Article 45, see the following document:

Publication of results-related information on paediatric studies submitted under Article 45 of the Regulation (EC) No 1901/2006 (‘Paediatric Regulation’)

Reference Number: EMA/428617/2011 Rev. 2 Summary:

In accordance with Article 41(2) of the Paediatric Regulation, the European Medicines Agency (the Agency) is required to publish the results of all the paediatric studies submitted to competent authorities in compliance with Articles 45 and 46 of the Paediatric Regulation.

English (EN) (148.78 KB - PDF)

First published: Last updated:
View

For more information, see:

Submitting information on paediatric studies under Article 46

Article 46 of the Paediatric Regulation required marketing authorisation holders to submit information on studies conducted in children for authorised medicines that have been completed since the regulation came into force on 26 January 2007 and are sponsored by the marketing authorisation holder. 

Information must be submitted within six months of completion of each study.

Submission of study results for assessment

For centrally authorised medicines:

  • Assessment reports of Article 46 studies are available on EMA's website, as part of the European public assessment reports (EPARs)
  • Information on how to submit studies is available in the post-authorisation procedural advice for the centralised procedure guidance, under the section 'Article 46 paediatric study submission':

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

Reference Number: EMEA-H-19984/03 Rev. 113

English (EN) (2.47 MB - PDF)

First published: Last updated:
View

For nationally authorised medicines:

Guidance on how to publish information on paediatric clinical trials is available in the section titled 'Guidance on publication of trial information' of the Paediatric clinical trials webpage.

For more information, see:

Post-authorisation procedural advice: questions and answers

Article 46 of Regulation (EC) No 1901/2006 (the 'Paediatric Regulation') sets out the obligation for marketing-authorisation holders (MAHs) to submit any MAH-sponsored studies involving the use of an authorised medicinal product in the paediatric population to the competent authority, whether or not they are part of a paediatric investigation plan (PIP). For centrally authorised medicinal products, the studies should be submitted to the European Medicines Agency.

This includes clinical studies that are:

  • completed or discontinued;
  • published or not.

Studies should be submitted regardless of the region where they were performed, the aim, outcome, design/methodology, population studied and indication.

References

The MAH should submit the paediatric studies within six months of its completion and irrespective whether or not it is part of a PIP (completed/or not yet completed) of whether it is intended for submission later on as part of a variation, extension or new stand-alone marketing-authorisation application or not.

Completion of a study is defined in the Communication from the Commission - Guideline on the format and content of applications for agreement or modification of a PIP and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies on the format and content of paediatric investigation plans. Clinical studies are deemed to have been completed on the date of the last visit of the last subject in the study or at a later point in time as defined in the protocol.

References

A paediatric study is to be submitted pursuant to article 46 as a post-authorisation measure (‘stand-alone’ submission). However, if amendments to be introduced to Product Information are identified by the MAH, a variation (e.g. category C.1.4 or C.1.6) should be submitted directly containing the article 46 paediatric study.

The submission of an application under article 46 should include the following documents, preferably presented in accordance with appropriate headings and numbering of the EU-CTD format:

  • Cover Letter including information on the context in which the article 46 paediatric study submission is made (e.g. stand-alone study or study included in a development program) and statement that there are no regulatory consequences identified by the MAH.
  • In order to facilitate the registration of the submission, marketing authorisation holders are required to fill in all the submission attributes through the eSubmission delivery file UI.
  • A completed PAM submission form with the full description of the PAM. The description should mention the due date (6 months from the completion of study). This form will ensure the correct classification of the submission, involvement of designated Committees(s) and timetable to be applied.
  • A short critical expert overview clarifying the context of the data, including information on the pharmaceutical formulation used in the study, the existence of a suitable paediatric formulation and if relevant, conditions for an extemporaneous formulation
  • Final clinical study report
  • For a paediatric study that is part of a development program, a line listing (see template) of all the concerned studies

In case of submission of a variation including study relevant to article 46, the application should be presented in EU-CTD format accordingly to the guidance for variation (see also in guidance on variations). The following box should be ticked in the variation application form: “THIS APPLICATION RELATES TO PAEDIATRIC STUDIES SUBMITTED ACCORDING TO ARTICLE 45 OR 46 OF THE PAEDIATRIC REGULATION”.

References

Information is available on ‘Submitting a post-authorisation application’.

The following 60-day timetable shall apply to the assessment of the paediatric study submitted by the MAH:

Day Action
Day 1 Start of the procedure as per published timetable (see below)
Day 30 Receipt of Rapporteur's Assessment Report
Day 45 CHMP Members' comments
Day 50 Receipt of Rapporteur's updated Assessment Report (if necessary)

Day 60 (CHMP meeting)

(up to Day 90 if a Request for Clarification is needed)

CHMP adoption of conclusion or Request for Clarifications

 

The submission deadlines and full procedural detailed timetables are published as a generic calendar on the EMA website (see: submission deadlines and full procedural timetables).

The published timetables identify the submission, start and finish dates of the procedures as well as other interim dates/milestones that occur during the procedure.

The EMA will inform the MAH of the outcome of CHMP evaluation. The following may be envisaged depending on CHMP's conclusion at D60:

  • No amendment to the product information is required at this point of time.
  • Further clarifications are required.The CHMP will request additional clarifications (directly linked to the paediatric study submitted) and a 30 days extension of the timeframe will normally apply.
  • A variation is needed to amend the product information in accordance with the CHMP conclusion. The variation submission is normally requested within 60 days after adoption of the CHMP conclusion. If the MAH is unable to submit the variation within this timeframe, he must justify the delay and inform the EMA/Rapporteur and propose a new submission date.

At the time of finalising an opinion, it may be needed that the MAH generate additional data (see also guidance on post-authorisation measures).

There is no fee payable for article 46 paediatric studies. However, the normal fees are applied to any variations containing Article 46 paediatric data or variations resulting from the assessment of such article 46 paediatric study submission.

The assessment report of the procedure will be published on the European Medicines Agency website under the EPAR tab of the product after removal of commercially confidential information.

References

Share this page

Back to top