EMA regulatory guidance update to prepare for Brexit

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

EMA regulatory guidance update to prepare for Brexit

Home/Guidelines | Posted 26/01/2018 0 Post your comment

In preparation for the UK’s withdrawal from the European Union (EU), set to take place on 29 March 2019, the European Medicines Agency (EMA) and the European Commission have issued regulatory guidance to pharmaceutical companies. The EU wants to ensure that pharmaceutical companies plan for Brexit to avoid any impact on the continuous supply of medicines within the EU.

This publication is an update to the questions-and-answers document published in May 2017. This update and others yet to come, will include additional information on how Brexit will affect marketing applications and authorizations for different types of medicinal products. The guidance relates to both human and veterinary medicines and, with this update, now includes new information for manufacturers of orphan drugs, generics and biosimilars, as well as hybrid medicines that rely on data from reference products and new clinical trial findings.

The guidance specifies that sponsors will no longer need to account for UK patients in the disease’s prevalence when calculating for orphan designations. They will only need to consider the requirement that the disease does not affect more than 5 in 10,000 people in the new EU of which the UK is not a part.

The EU urges companies to stay up-to-date and regularly check the EMA webpage dedicated to the consequences of Brexit.

NHS England to increase biosimilar usage

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: EMA