The United Kingdom (UK) has left the European Union (EU) and the transition period after Brexit comes to an end this year and from 1 January 2021 new regulations will apply. These changes will also affect the EU paediatric investigation plan (PIP) maintenance and procedures.
The UK competent authorities, the Medicines and Healthcare products Regulatory Agency (MHRA), recently published some preliminary guidance on the procedures and scenarios in the case of a no-deal Brexit with further guidance to follow. https://www.gov.uk/guidance/procedures-for-uk-pips-in-the-event-the-uk-leaves-the-eu-without-a-deal
Asphalion has already worked in more than 15 successful PIPs, so in case of any concerns related to paediatric development and PIPs, please contact us at [email protected].
