Public consultation on Commission guideline on paediatric investigation plans (PIP)

New legislation governing the development and authorisation of medicines for paediatric use - Regulation (EC) N° 1901/2006 - entered into force in the European Union on 26 January 2007.

04/07/2017
Responses to the consultation to gather stakeholders' experiences of the EU Paediatric Regulation.

A public consultation took place from 15 November 2016 to 20 February 2017 to gather stakeholders' experiences of the EU Paediatric Regulation.

A summary of the comments as well as the replies are available here.

19/09/2016
Expert meeting with Member States and the European Medicines Agency.

On 19 September 2016 a paediatric expert group meeting took place in Brussels to discuss the experience with the Paediatric Regulation. Representatives from Member States and the European Medicines Agency and its Paediatric Committee participated at the meeting.

13/05/2016
Annual report on benefits and infringements under the Paediatric Regulation.

On an annual basis the European Medicines Agency reports on companies and products that have benefitted from the rewards and incentives provided by the Paediatric Regulation No 1901/2006 as well as on companies that have failed to comply with any of the obligations in that Regulation. This report is published by the Commission in accordance with Article 50(1) of the Regulation.

The report covering the year 2015 is available here.

29/05/2015
Annual report on benefits and infringements under the Paediatric Regulation.

The report covering the year 2014 is available here.

30/09/2014
New Commission guideline on paediatric investigation plans.

The Commission publishedon 27 September its new guideline on applications for paediatric investigation plans (PIP) under the Paediatric Regulation (EC) 1901/2006. This update follows a commitment in the 2013 progress report . Amongst other things, it simplifies the structure of the guideline, establishes a list of key elements of a PIP and introduces increased flexibility into the application process. Additionally, new study concepts, such as extrapolation and modelling are better recognised and requirements for the compliance check have been clarified. It is expected that the new guideline will contribute to an efficient and proportionate filing process of paediatric investigation plans.

The text of the guideline is available in all EU languages here .

The new guideline is immediatlly applicable as of today. However, until end of 2014 the European Medicines Agency continues to accept paediatric investigation plans that have been prepared in accordance with the previous guideline.

02/05/2014
Responses to the public consultation on the Commission guideline on paediatric investigation plans.

A public consultation took place from 9 October 2013 to 3 January 2014 on the Commission guideline on paediatric investigation plans.

A summary of the comments as well as the replies are available here.

05/09/2013
Commission Call for Expression of Interest for the position of member for the Paediatric Committee (PDCO).

This call for expressions of interest relates to the appointment by the Commission of members and alternates representing patient associations and health professional organisations at the Paediatric Committee of the European Medicines Agency. More detailed information and application documents are here: ZIP file.

24/06/2013
First Commission Report on the Paediatric Regulation.

The Commission has published a progress report on medicines for children covering the five years since the Paediatric Regulation first came into force. This preliminary snapshot points to improvements in the paediatric medicines landscape: better and safer research, more medicines for children on the EU market and more information for parents and health professionals. The report is available here .

16/05/2013
Annual report on benefits and infringements under the Paediatric Regulation.

Once a year the European Medicines Agency prepares a report on companies and products that have benefitted from the rewards and incentives provided by the Paediatric Regulation No 1901/2006 as well as on companies that have failed to comply with any of the obligations in that Regulation. This report is published by the Commission in accordance with Article 50(1) of the Regulation.

The report covering the year 2012 is available here. As a new element it analyses for the first time the obligation of reporting annually on deferred studies. Additionally, it gives an overview of the completion of paediatric investigation plans so far.

16/01/2013
Responses to the public consultation on the experience acquired with the Paediatric Regulation.

A public consultation took place from 19 September 2012 to 28 November 2012 on the experience acquired with the Paediatric Regulation (Regulation (EC) No 1901/2006) in preparation of a Commission report on this legislative instrument which is due for 2013.

A summary of the comments as well as the replies are available here.

24/07/2012
Annual report on benefits and infringements under the Paediatric Regulation.

In accordance with Article 50(1) of the Paediatric Regulation (Regulation (EC) No 1901/2006 ) the Commission publishes on an annual basis a report prepared by the European Medicines Agency on companies and products that have benefited from the rewards and incentives provided by the Paediatric Regulation as well as on companies that have failed to comply with any of the obligations in that Regulation.

The report covering the year 2011 is available here (corrected September 2012).

04/05/2011
Annual report on benefits and infringements under the Paediatric Regulation.

The Paediatric Regulation (Regulation (EC) No 1901/2006 ) provides incentives and rewards to companies that have undertaken research into, and the development and authorisation of pharmaceuticals for children. The Commission is obligated to report on companies and products that have benefited from those rewards and incentives as well as on companies that have failed to comply with any of the obligations in the Regulation (Article 50(1) of the Regulation).

In this regard the European Medicines Agency has compiled a report covering the year 2010. The report is available here.

22/06/2010
Commission is looking for health professionals and patient representatives for the Paediatric Committee.

The Paediatric Regulation (Regulation (EC) No 1901/2006) establishes a scientific committee, the Paediatric Committee, with expertise and competence in the development and assessment of all aspects of medicinal products to treat paediatric populations. This committee shall include representatives of the civil society, which represent patient associations and health professionals.

Those members are appointed by the Commission for a renewable period of three years on the basis of a public call for expression of interest.

Today the Commission publishes such call and invites health professionals and patient associations to put forward candidatures, until 6 September 2010 at the latest, for a new mandate starting in 2011.

Details concerning the requested candidate profiles, the work of committee members, the application and selection procedure can be found in the following Public call for expression of interest (PDCO/10/PH/1) can be found here.

10/09/2010 update
The Commission decided to prolong the deadline for submitting applications until 6 October 2010. Furthermore it is clarified that the proposed member and the proposed alternate do not have to represent necessarily the same association. Different association may decide to suggest together a pair of candidates.

02/06/2010
Report on rewards and incentives under the Paediatric Regulation.

The Paediatric Regulation (Regulation (EC) No 1901/2006) provides incentives and rewards to companies that have undertaken research into, and the development and authorisation of pharmaceuticals for children. The Commission is obligated to report on companies and products that have benefited from those rewards and incentives as well as on companies that have failed to comply with any of the obligations in the Regulation (Article 50(1) of the Regulation).

In this regard the European Medicines Agency has compiled a report, which covers the first three years of the Paediatric Regulation from its entry into force to 2009.

The report is available here.

25/11/2008
Responses of public consultation in preparation of the "Communication from the Commission - Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on the criteria for assessing significant studies" ("PIP Guideline").

A public consultation took place from 31 January 2007 and 30 March 2007 in preparation of the "Communication from the Commission - Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on the criteria for assessing significant studies" ("PIP Guideline").

A summary of the comments as well as the replies are available here.

24/09/2008
Guideline on the format and content of applications for agreement or modif ication of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies.

The Guideline on the format and content of applications for agreement or modif ication of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies is available here (Official Journal C 243/1, 2008).

30/07/2008
Inventory of rewards and incentives to support medicinal products for paediatric use.

Pursuant to Article 39 of the paediatric regulation (Regulation EC (No) 1901/2006) the first inventory of Community and Member State rewards and incentives to support research into, and the development and availability of, medicinal products for paediatric use is made public.

The document is available here.

30/01/2008
Ethical considerations for clinical trials in children.

The ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use, chaired by the Commission services, has adopted recommendations on various ethical aspects of clinical trials performed in children. These recommendations will contribute to the protection of children who are the subject of clinical trials. Furthermore, the recommendations are intended to facilitate a harmonised application of rules on clinical trials across the EU and thereby facilitate the conduct of clinical trials in the EU.

These recommendations are published in Eudralex Volume 10 - Clinical trials (Chapter V: Additional Information) and can be downloaded here here.
A summary of the consultation response can be found here.

30/01/2008
Commission at present not in a position to select a symbol for medicines authorised for a paediatric indication.

Article 32 of the Paediatric Regulation (Regulation (EC) No 1901/2006) foresees that medicinal products granted a marketing authorisation for a paediatric indication shall display a symbol for their identification. Following this Regulation, the selection of the symbol by the European Commission is to be based on a recommendation of the European Medicines Agency Paediatric Committee. The Regulation provides for the Commission to select the symbol by 26 January 2008 and make the symbol public. On the 20th of December 2007 the Paediatric Committee adopted its recommendation regarding the symbol by a majority vote of eighteen against four. The adopted recommendation is that "As a consequence of its analysis balance of benefits and risks of the symbol, the Paediatric Committee was unable to recommend to the European Commission any symbol for which the benefits would outweigh the risks identified and dominated by potentially fatal medication errors".

Publication of this announcement serves to inform stakeholders that on the basis of this recommendation, the European Commission is at present not in a position to select a symbol and the provisions of Article 32 of the Paediatric Regulation cannot therefore be implemented.

The full recommendation of the Paediatric Committee to the European Commission regarding the symbol can be found here.

18/06/2007
Transatlantic cooperation on medicines regulation expanded.

On 14 and 15 June the bilateral meeting between the European Commission and European Medicines Agency and the United States Food and Drug Administration made important progress on expanding transatlantic regulatory cooperation.

The joint press release can be accessed here.
The 'Principles for Interaction' on medicines for children can be accessed here.

12/06/2007
Paediatric Committee: Commission call for expressions of interest.

Today the Commission launches a call for expressions of interest as Commission appointees to the European Medicines Agency Paediatric Committee. The deadline for expressions of interest is 31 August 2007 which should be sent to Peter Arlett at the European Commission in electronic form. Further details, including the criteria for selection can be found here.

On 29 September 2004 the European Commission adopted a proposal for a Regulation of the Council and of the Parliament on Medicinal Products for Paediatric Use.

09/01/2007
Regulations (EC) No 1901/2006 and No 1902/2006.

Regulations (EC) No 1901/2006 and No 1902/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use was published in the Official Journal on 27 December 2006 and will enter into force on 26 January 2007.
The different language versions can be found here.

New rules on the adoption of implementing texts by the European Commission (so called 'comitology' rules) were adopted after the 'second reading agreement' between the European Parliament, the Council and the Commission on the paediatric regulation. Therefore a regulation has also been adopted and published to bring the paediatric regulation in line with these new 'comitology rules' (Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation).
The different language versions can be found here.

25/09/2006
Implementation of the Paediatric Regulation.

Today DG Enterprise and Industry makes public its priorities for implementation of the Regulation on medicinal products for paediatric use (the paediatric regulation). The priorities document has been developed and agreed with the European Medicines Agency (EMEA). It should be noted that the precise dates of adoption, publication and entry into force of the paediatric regulation are not known at the present time, however, based on our best estimates, the prioritisation document assumes entry into force in January 2007.

The joint Commission and EMEA document can be found here.

Frequently asked questions.

Consultation on the draft document on "Ethical Considerations for Clinical Trials Performed in Children - Recommendations of the Ad Hoc Group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use".

DG Enterprise and Industry releases a draft document on 'Ethical considerations for Clinical Trials Performed in Children - Recommendations of the Ad Hoc Group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use.

This document provides recommendations on various ethical aspects of clinical trials performed in children, intending to contribute to their protection as the subject of clinical trials as well as to facilitate a harmonised approach to clinical trials across the EU Member States, considering that the approval of clinical trials, including ethical approval, is primarily a national competence, thereby facilitating the conduct of clinical trials in the European Union.

We invite comments on the draft document to be provided using this template until 31 January 2007.

Commission Communication regarding the Council Common Position on the paediatric regulation.

On 13 March 2006 the European Commission adopted a Communication concerning the common position of the Council with a view to the adoption of a regulation on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004.

Text of Commission Communication COM(2006) 118 final of 13 March 2006.

Text of modified proposal COM(2005) 577 final of 10 November 2005.

Discussions in the Council are progressing well and the proposed regulation on medicinal products for paediatric use will be discussed at the Health Council of 9 December 2005.

Text of the proposal.

Please note that translations of the text of the proposal into all other official EU languages will be added to this web-site in October 2004.

Related information

Details

Publication date: 9 October 2013
Author: Directorate-General for Health and Food Safety