How the UK handles paediatric investigation plans after Brexit
Since 2021 the MHRA has run its own paediatric regime for Great Britain. For most companies it means one more plan to agree, not a different philosophy.
In brief
Since 2021 the MHRA has run its own paediatric regime for Great Britain. How UK paediatric investigation plans work and where they can differ from the EU.
Until the end of 2020, a paediatric investigation plan agreed with the European Medicines Agency covered the UK automatically. From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) became responsible for paediatric requirements in Great Britain, and companies seeking a GB licence needed to address them separately.
Same rules, new regulator
The UK carried the substance of the EU Paediatric Regulation into domestic law. A marketing authorisation application for a new medicine in Great Britain still needs an agreed UK paediatric investigation plan, a waiver or a deferral. The reward for completing an agreed plan, a six-month extension to the supplementary protection certificate, also remains.
What changed is the paperwork and the timetable. The MHRA reviews UK plans itself and has set out a streamlined route for products that already have a plan agreed in the EU, recognising that most sponsors will not want to design a separate paediatric programme for one market.
Where differences can emerge
Divergence is most likely at the margins. The two regulators can reach different views on waivers, on the age groups that need to be studied, or on the timing of deferred studies. A modification agreed in Amsterdam is not automatically mirrored in London.
Northern Ireland adds a further layer. Under the Windsor Framework, arrangements for medicines there differ from those in Great Britain, and companies need to check which regime applies to their product.
The practical upshot
For large sponsors, a UK plan has become one more regulatory submission, usually run in parallel with the EU one. For smaller biotechs, the extra workstream can be a genuine cost. The MHRA’s pitch is that a nimbler regulator can be more flexible on paediatric requirements than a 27-country system. Whether that holds in practice will show up in how quickly UK plans are agreed and how often they diverge.
