Today we visit the topic of Paediatric Investigation Plans (PIPs) and all related submissions to the Medicines and Healthcare products Regulatory Agency (MHRA) – the UK Health Authority.
The background to Paediatric Investigation Plans has been covered in our blog on PIPs in the EU and is also applicable to the UK. Similarly to the EU, applications for the agreement of a PIP should be submitted ‘not later than upon completion of the human pharmaco-kinetic studies’ unless duly justified – according to Regulation 50B(3) of the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (HMRs).
Since leaving the EU, the MHRA has confirmed that all EU-PIPs, modifications and full product specific waivers with an EMA decision agreed before 1st January 2021, will be adopted as UK-PIPs. If the EMA’s Paediatric Committee (PDCO) issued a negative opinion, the MHRA will treat the application as refused, however the applicant is able to resubmit to the MHRA addressing the reasons for refusal. Northern Ireland continues to be part of the EU’s system for paediatric medicines development.
All PIP related applications submitted to the MHRA following the 1st January 2021 must be submitted via the MHRA’s submission portal. The MHRA has published guidance on the required format and content and the following should be included in the cover letter (where applicable):
- details of an agreed EU-PIP, the opinion and supporting documentation
- details of any ongoing EU-PIP assessment, the submission date and timetable (i.e. day 30, 60, clock stop, day 90 or 120)
- details of any scientific divergence between the MHRA PIP application and the EU-PIP.
In scenarios where there is a delay in the UK PIP submission, the MHRA will aim to maintain alignment where a positive opinion has been issued by the PDCO. However, divergence could occur since decisions for PIPs are based on national and NHS paediatric public health needs.
The MHRA are taking a similar approach for all PIP related submissions including PIP modifications, compliance checks and waivers. The current EMA class waivers list has been adopted by the MHRA from 1 January 2021 and in principle, they will aim to continue to accept a positive EMA opinion on a class waiver request. Where there is no EMA opinion, a MHRA assessment will be undertaken.
Fusion Pharma has direct experience in submitting PIPs, modifications, waivers and compliance check requests to the MHRA. If you would like to discuss how Fusion Pharma can support you with your PIP submissions, please email us at firstname.lastname@example.org or phone on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.