Two scientists in suits and a clean room testing pharmaceutical products

ABPI: New guidance allows focus to be on getting medicines to patients

New regulations for the batch testing of imported medicines should allow pharmaceutical companies to focus more closely on getting treatments and vaccines to patients, according to the Association of the British Pharmaceutical Industry (ABPI).

The comment come as the MHRA updated its guidance for batch testing of imported medicines following the end of the Brexit transition period.

During negotiations for the Trade and Cooperation Agreement, the pharmaceutical industry urged both the UK and European Union to sign a mutual recognition agreement (MRA) for inspections, batch release and testing.

In the end, the UK and EU agreed to mutually recognise inspections but not batch testing.

This would have meant UK companies would be required to set up duplicative, and potentially unnecessary, batch testing operations. This is often a long, complex and costly process.

In efforts to support the process, the UK unilaterally waived batch testing requirements for products coming from the EU for two years, including Covid-19 vaccines.

However, this still required UK companies to have set up a robust batch testing procedure within two years, by December 2022 - a difficult ask at the best of times.

As such, to help mitigate this, under the new MHRA guidance the UK Government will stick to its current position of recognising batch testing from the EU/EEA for the time being.

It will also commit to giving companies two years notice if it plans to move away from this position.

This notice can only be triggered following a comprehensive review of future batch testing requirements, which must be completed by December 2022.

In response to the guidance changes, ABPI Chief Executive Richard Torbett said: “For many companies, setting up new batch testing operations in two years would be challenging at the best of times.

“The impact of Covid-19 now makes that impossible.

“This pragmatic guidance means that companies won’t have to set up duplicative batch testing facilities immediately, and can instead focus on making sure medicines and vaccines get to patients in the UK, EU, and around the world.

“We will continue to engage constructively with our members and the government to ensure the outcome of any review supports the continued success of the UK’s life sciences sector.”

National Health Executive, Jan/Feb, Cover

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