Paediatrics: Regulatory and procedural guidance

General

The European paediatric initiative: History of the Paediatric Regulation

Reference Number: EMEA/17967/04 Rev 1

Joint European Commission / European Medicines Agency document: Priorities for implementation of the regulation on medicinal products for paediatric use

Better medicines for children

Guidance on the content and the format of data to be collected by the Member States on all existing uses of medicinal products in the paediatric population

AdoptedReference Number: EMEA/575696/2007

Example of a template for communicating a Member State's data on all existing uses of medicinal products in the paediatric population to the Agency

Adopted

Revised priority list for studies on off-patent paediatric medicinal products

Reference Number: EMA/98717/2012 Rev. 2012

Recommendation of the PDCO to the European Commission regarding the symbol

Reference Number: EMEA/498247/2007

Report from the PDCO on its first anniversary

Reference Number: EMEA/PDCO/347884/2008

• Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 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
• Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use
• Inventory of Community and Member State rewards and incentives to support research into, and the development and availability of, medicinal products for paediatric use
• Inventory of paediatric needs
• Paediatric clinical trials
• Ethical considerations for clinical trials on medicinal products conducted with the paediatric population (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)

Paediatric Investigation Plan (PIP) and waivers

Re-examination procedure of paediatric investigation plan and / or waiver opinions by the PDCO

Reference Number: EMEA/23604/2008 Re. 1

Standard operating procedure for European Medicines Agency decision-making process for decisions on Paediatric Committee opinions

AdoptedReference Number: SOP/H/3455Legal effective date: 15/12/2017Summary:

Standard operating procedure for European Medicines Agency decision-making process for decisions on Paediatric Committee opinions

Annual report on deferral granted in the paediatric investigation plan - (PED6) certified

Reference Number: Version 1.0.6

P/60/2008: European Medicines Agency decision of 8 September 2009: on a class waiver on a class of medicinal products in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Council as amend...

AdoptedReference Number: EMEA/386453/2008

P/63/2010: EMA decision of 20 December 2010 on a class waiver on condition(s)

AdoptedReference Number: EMA/820860/2010

Standard operating procedure for paediatric investigation plan from re-start of procedure (after clock-stop) to PDCO opinion

AdoptedReference Number: SOP/H/3453Legal effective date: 01/12/2017

• European 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 criteria for assessing significant studies
• Paediatric investigation plans (PIPs), waivers and modifications - Procedural Advice
• Contact details for PDCO members and alternates for sending PIP applications

• Post-authorisation guidance - Article 46 (Q&A)