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).
This is a requirement from Articles 45 and 46 of the Paediatric Regulation.
All clinical trials in scope of Articles 45 and 46, or included in an agreed paediatric investigation plan (PIP), can be accessed through the EU Clinical Trials Register.
The register also displays information on older paediatric trials in scope of Article 45 of the Paediatric Regulation.
The publication of this information is in accordance with Article 41 of the Paediatric Regulation.
Article 45 requires marketing-authorisation holders for medicines authorised in the EU to submit information on all paediatric studies completed by 26 January 2007, the date of entry into force of the Paediatric Regulation. This includes medicines authorised centrally and nationally.
Submission of study results for assessment
The Agency and the national competent authorities are currently assessing the results of the paediatric studies submitted by marketing-authorisation holders. Due to the large amount of information on nationally authorised medicines, the assessment is processed in several waves.
For nationally authorised medicines, modalities and timing for submitting results of studies for assessment as part of worksharing procedures can be found in the Best practice guide on Article 45 EU worksharing procedure.
Assessment reports of Article 45 studies for nationally authorised medicines are available on the Heads of Medicines Agencies website.
Assessment reports of Article 45 studies for centrally authorised medicines are available on the EMA website as part of the European public assessment reports (EPARs).
Submission of study results for publication
Marketing authorisation holders were required to submit the results of studies in scope of Article 45 of the Paediatric Regulation by 2011.
Outstanding results can still be submitted by sending one of the following to firstname.lastname@example.org:
- a copy, authorised by the copyright-holder, of a medical journal article as the synopsis in accordance with Annex I to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Topic E 3 guidance;
- any other appropriate document containing the information in that synopsis.
Please note that these documents must not contain personal data or confidential information.
For studies referenced in the Medline database, the PubMed ID or declaration of interest should also be provided.
For more information, see:
If an interventional clinical trial in scope of Article 45 is also part of an agreed Paediatric Investigation Plan (PIP), protocol and result-related information has to be posted directly to the EudraCT database using the full EudraCT data set.
Article 46 requires marketing-authorisation holders to submit information on studies conducted in children of authorised medicines that have been completed since the Paediatric 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:
- information on how to submit studies is available in Submission of Article 46 paediatric study: questions and answers.
- assessment reports of Article 46 studies are available on the EMA website as part of the European public assessment reports (EPARs).
For nationally authorised medicines:
- information on how to submit studies is available in the Best practice guide on Article 46 EU worksharing procedure.
- assessment reports of Article 46 studies for nationally authorised medicines are available on the Heads of Medicines Agencies website.
Posting study results for publication
Result-related information from clinical trials in scope of Article 46 of the Paediatric Regulation has to be posted directly to the EudraCT database using the full EudraCT data set. If protocol-related information is not already held in EudraCT (e.g. if the trial is conducted outside the EU), prior upload of a protocol file to EudraCT is necessary together with the result-related information to complement the required trial results.
In order to post this information, users need to be registered with EudraCT. For more information, see EudraCT user roles.
Result-related information for interventional clinical trials in children and/or adults included in an agreed PIP has to be posted directly to the EudraCT database using the full EudraCT data set.
For more information, see Paediatric clinical trials
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