New MHRA and FDA liaison programme announced

A new collaboration between the UK and US medicines watchdogs will support ‘scientific exchange’ and the development of safe products across both countries.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) have announced that a new programme will establish dedicated liaison officer roles within each organisation.

This aims to improve collaboration and enable more coordinated approaches to regulatory challenges and decisions, the MHRA said.

It added that both agencies will maintain full regulatory independence despite becoming ‘increasingly aligned’.

Related Article: UK-US pharma deal faces threat of legal challenge

Speaking at the DIA Global Annual Meeting in Philadelphia last week, MHRA chief executive Lawrence Tallon and FDA deputy commissioner Grace Graham announced that the initiative will ‘formalise and deepen’ cooperation between the two agencies.

Key focus areas will include innovative medicines, medical devices, and emerging technologies such as artificial intelligence (AI).

Mr Tallon said: ‘By creating dedicated liaison roles, we are taking our collaboration to a new level, improving how we share expertise, align on regulatory science and technology, and respond to the pace of innovation.

‘This will help product developers cross the Atlantic, in both directions, because our regulatory decisions will become more closely aligned, reducing friction to market from the UK to the US and vice versa.’

Ms Graham added: ‘We’re excited to launch this new initiative that will enhance institutional knowledge within the FDA and MHRA, improving the global oversight of drugs, biologics, and medical devices as we look to secure supply chains and ensure appropriate standards for clinical research.’

The MHRA said the liaison programme is designed to support closer working across technical, policy and scientific teams, creating new opportunities for joint initiatives, shared learning and coordinated approaches to complex regulatory issues.

Related Article: Landmark deal between the UK and US will expand medicine access for thousands

This announcement follows a ‘landmark’ pharmaceutical deal between the UK and the US which aims to expand access to new medicines, safeguard the country’s medicine supply chain, and drive investment in the life sciences sector.

In October, the MHRA also announced it would ‘deepen’ collaboration with the FDA on medical technologies and AI.

The FDA is responsible for protecting public health in the United States by ensuring the safety, efficacy and security of human and veterinary medicines, biological products, and medical devices.

Chief executive of the Association of British HealthTech Industries (ABHI), Peter Ellingworth, said: ‘For HealthTech companies operating across global markets, greater alignment between trusted regulators reduces costs and complexity and supports more efficient routes to market.

Related Article: Warnings for ACE inhibitor side effects strengthened by MHRA

‘Closer cooperation between the MHRA and FDA is therefore a positive step towards a more connected regulatory environment.’

The MHRA said that job descriptions, adverts and eligibility criteria will be published in due course.

Related Article: Novel flu and coronavirus infections remain greatest health security threats