The World Health Organization (WHO) has confirmed the redesignation of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as one of its global collaborating centres for the standardisation and evaluation of biologicals.
The MHRA’s Science and Research group is one of four global institutions entrusted with the WHO’s international biological reference preparations, which include global regulation and standardisation of biological medicines such as vaccines and other complex biologics.
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The renewed designation is for a four-year term and includes responsibilities such as developing and distributing international reference materials, conducting research to assure biological product quality, and providing technical support to WHO regional offices.
“Biological medicines are an increasingly important part of healthcare. Our role as the UK medicines regulator is to make sure the medicines people take are of an acceptable quality,” said Nicola Rose, interim executive director for science and research at the MHRA in the 9 April announcement.
The timing of this announcement comes three months after US President Donald Trump issued an executive order mandating the US withdrawal from the WHO and an immediate cessation of collaboration by all federal agencies, including the Centers for Disease Control and Prevention (CDC).
The Trump administration’s directive – signed on the day of his inauguration in January 2025 – has led to the abrupt severance of US support for WHO programmes, the recall of American personnel embedded at the UN health agency, and the freezing of funding lines. Public health officials at the CDC and National Institute of Allergy and Infectious Diseases (NIAID), both previously involved in WHO laboratory networks, have been instructed to halt all WHO-linked activities.
The CDC had historically served as custodian for multiple WHO reference standards – including smallpox virus research – one of only two authorised repositories worldwide. The status of these facilities is now uncertain.
On top of the WHO withdrawal, USAID has also been terminated, leading to the suspension of HIV, malaria, and tuberculosis treatment distribution to low- and middle-income countries – compounding the health risks in regions where neglected tropical diseases remain endemic. In January 2025, the WHO published an alert on 21 such diseases, underscoring the need for sustained international coordination, which is now under pressure.
The geopolitical shift is also potentially redrawing the competitive landscape for global regulatory leadership. The US Food and Drug Administration (FDA) is undergoing an internal restructuring, with senior figures – including Peter Marks, former head of the Center for Biologics and Evaluation and Research – departing as some experts raise concerns about the stability of the US regulatory environment.
At the OBN BioTrinity conference in London on 2 April 2025, OBN CEO Stuart Rose said the disruption at the FDA could create a strategic opening for the MHRA to attract more business.
In January 2025, AstraZeneca scrapped plans to invest £450m in expanding a vaccine manufacturing plant in Merseyside, UK, blaming reduced government support. The company had already been considering relocating its manufacturing facilities from the UK to the US, as reported in August 2024.
The White House has signalled support for a renewed push to onshore pharmaceutical manufacturing. Trump stated earlier this week that the country is set to announce “major tariffs” on pharmaceutical imports soon.
These tariff announcements have seen some big pharma companies increase onshoring plans in the US. MSD recently opened a $1bn manufacturing facility in North Carolina to increase production of its blockbuster HPV vaccine, Gardasil. The company described the investment as part of a broader $12bn commitment to US capital investment since 2018, with another $8bn expected by 2028.
