BIA welcomes updated guidance from the MHRA on approved countries for batch testing

The BioIndustry Association (BIA) has welcomed updated guidance from the MHRA published today which makes changes to the list of approved countries for batch testing and the importation of medicines.

The changes mean that batch testing will continue to be accepted from listed European Economic Area countries, while an evidence based review is conducted on what batch testing should look like in future. At the end of this review, there will be a two year notice period before any new arrangements are introduced. Previously, the guidance suggested that batch testing conducted in EEA countries would only be accepted until 1 January 2023.

Steve Bates OBE, CEO of the BioIndustry Association, welcomed the announcement: “This pragmatic change in guidance ensures that UK patients continue to be able to access medicines and gives companies more time to prepare for new arrangements. This is particularly important in the context of COVID-19. With many companies diverting resources toward fighting the pandemic or being forced to redesign supply chains, there has been less resource to prepare for new batch testing requirements from 1 January 2023.

“While the BIA’s priority is still for a mutual recognition agreement between the UK and EU, we are pleased that the work the BIA and the wider sector has done with government officials has led to this outcome. We look forward to working to shape the upcoming review. This review will need to consider all of the implications for future batch testing arrangements, including the overlap with new regulatory processes and batch testing’s impact on UK competitiveness. In particular, special consideration will need to be given to some batch testing processes for biologics. For example, cell based assays which can take over 18 months to get operational, and viral load tests which require separate labs to avoid cross contamination."

Notes to Editors 

1. To read the updated guidance, please follow this link. 

2. Please contact Jack Fellows, Communications and Media Manager [email protected] for further information.