MHRA’s guidance on EU paediatric compliance
This article was originally published in Scrip
Before submitting a marketing authorisation to the UKMHRA, the agency strongly advises pharmaceutical companies to seek an opinion from theEMEA's paediatric committee on whether the application complies with the paediatric investigation plan (PIP), otherwise the MHRA itself will submit it to the committee.
The agency points out that this approach is also being taken by other member state authorities, and it believes it will enable the paediatric committee to establish agreed levels of scrutiny over compliance so that all regulatory authorities operate to the same standards.
From January 26th, 2009, the compliance check will additionally apply to variations or extension applications, ie, those seeking authorisation for a new indication, including a paediatric indication, a new pharmaceutical form or a new route of administration.
The European commission has drafted a guideline on the content of PIPs, outlining the requirements for a compliance check, which include that the documents submitted cover all subsets of the paediatric population and both existing and new indications, pharmaceutical forms and routes of administration.
Applicants are encouraged to prepare a compliance report, with a table setting out their position on compliance with each key element of the PIP decision.
The paediatric committee will verify whether studies comply with PIPs in the following cases:
* when the applicant requests the committee gives its opinion before it submits an application;
* when the EMEA or the MHRA requests the committee gives an opinion during validation; or
* when CHMP or the MHRA have doubt as to whether there has been compliance during an assessment and an opinion has not already been requested.
The committee must give its opinion within 60 days of receiving the request.
The requirement for companies seeking marketing authorisations in the EU to submit paediatric trial results came into effect for new substances (those not yet approved in the EU) on July 26th, unless they have a waiver or deferral from the paediatric committee.
The PIP requirement is designed to increase the number of medicines available that are specifically adapted for use in children; to increase the information to the patient/carer and prescriber about the use of medicines in children, including trial data; and to increase the levels of high quality research into medicines for children.