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sábado, 30 de mayo de 2009
European Medicines Agency - Human Medicines - Medicines for children - Paediatric investigation plans (PIPs), waivers and modifications
Medicines for children Guidance for applicants Electronic-only submissions: Starting with the 12 June deadline, the EMEA will accept electronic-only applications for Paediatric Investigation Plans, Waivers, Modification of Agreed Paediatric Investigation Plans, and Compliance check. This also applies to responses to the Request for Modifications. Applicants should submit their applications as a CD or DVD with a cover letter. As previously, the deadlines refer to the last acceptable day of receipt of electronic documents (via either Eudralink or CD/DVD).
Paediatric investigation plans (PIPs), waivers and modifications The Paediatric Regulation requires, where necessary, the early submission of a development plan for medicines — the paediatric investigation plan. The normal development of a medicine requires that various studies be performed to ensure its quality, safety and efficacy. The development plan can be modified with increasing knowledge about the medicine.
A paediatric investigation plan is a development plan aimed at ensuring that the necessary data are obtained through studies in children, when it is safe to do so, to support the authorisation of the medicine for children. The plan should be submitted by pharmaceutical companies to the Paediatric Committee, which is responsible for agreement or refusal of the plan.
The paediatric investigation plan includes a description of the studies and of the measures to adapt the way the medicine is presented (formulation) to make its use more acceptable in children. For example, children cannot swallow big tablets, so a syrup may be more appropriate.
The plan should cover the needs of all age groups of children, from birth to adolescence.
The plan also defines the timing of studies in children compared to adults. In some cases, studies will be deferred until after the studies in adults have been conducted, to ensure that research with children is done only when it is safe and ethical to do so.
As some diseases do not affect children (for example Parkinson's disease), the development of medicines for these diseases should not be performed in children, and so a paediatric investigation plan will not be required by the Paediatric Committee; the requirement for a PIP will therefore be waived in these cases.
On 24 September 2008, the European Commission published the final version of the guideline entitled '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'.
Commission Communication (2008/C 243/01). The guidelines can be found here.
Relevant documents: Guidance:
European Commission guideline on format and content of applications for paediatric investigation plans Applicants are reminded that the format of the scientific document (parts B to E) for PIP/waiver applications has changed, in accordance with the new EU guideline. The document should follow the outline published in the last page of the "Electronic template for PIP applications".
Frequently asked questions on regulatory aspects of Regulation (EC) No 1901/2006 (Paediatric Regulation) amended by Regulation (EC) No 1902/2006 (EMEA/520085/2006). Updated 2 September 2008 Procedural advice Updated 28 May 2009 Contact details for PDCO members and alternates for sending PIP application Templates:
Template letter of intent Rev. 3 Updated 31 October 2008
Electronic template for PIP applications or request for waiver – Updated 26 January 2009
A list of the changes in the new form is available here
* To use the template you will need version 8 or above of the free Adobe Reader on your PC, which you can download here.
* Template for the PDCO Summary Report (including internal guidance - published for information
* Request for modification of an agreed paediatric investigation plan Published 28 May 2009
* Request of confirmation of the applicability of the EMEA decision on class waivers Published 21 July 2008
Deadlines* and PDCO meeting dates: - PDCO meeting dates 2008 Rev. 3 Updated 27 August 2008 - PDCO meeting dates 2009 Rev. 2 Updated 26 September 2008 - PDCO meeting dates 2010 - PDCO meeting dates 2011 .. Submission deadlines 2008-2009 for PIPs and Answers to RfM .. Submission deadlines 2008-2009 for modification of an agreed PIP .. Submission deadlines 2008-2009 for compliance check .. Submission deadlines 2010-2011 for PIPs and Answers to RfM .. Submission deadlines 2010-2011 for modification of an agreed PIP .. Submission deadlines 2010-2011 for compliance check * Deadlines for submission of applications / responses to the EMEA: please note that the published date refers to the last acceptable day of receipt of electronic documents (via Eudralink or CD/DVD)
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