ABPI response to Government's future strategy for batch testing of medicinal products in Great Britain

The Government has announced its future strategy for batch testing of medicinal products in Great Britain.

The Government has announced its future strategy for batch testing of medicinal products in Great Britain.

Welcoming the announcement, Richard Torbett, ABPI Chief Executive said: 

“This important decision gives much needed regulatory clarity to pharmaceutical companies in the UK.

“The government has listened to evidence from the ABPI and from across the life sciences sector to agree a pragmatic approach which will eliminate duplicative testing requirements. 

“Companies have been waiting for this decision for a number of years and this will now give them the certainty they need to plan for the future supply of medicines to patients.”

What is batch testing?

When medicines are manufactured, they need to undergo a testing process of confirming every batch of medicine has the correct composition through laboratory tests by the manufacturer, this ensures that every medicine that reaches a patient is of the appropriate quality and therefore has the desired therapeutic effect.

During negotiations for the Trade and Cooperation Agreement, the pharmaceutical industry urged the UK and the EU to sign a Mutual Recognition Agreement (MRA) for inspections, batch release and testing.

Ultimately, both sides agreed to mutually recognise inspections but did not agree to mutually recognise batch testing.

Setting up duplicative and unnecessary batch testing operations is a long, complex, and costly process. To support companies during the pandemic, the UK unilaterally waived batch testing requirements for products coming from the EU for two years, including for COVID-19 vaccines.

Today’s announcement confirms that the UK government will stick to the current position of recognising batch testing from the EU/EEA, and from listed counties, further information is available here.