Medicines regulator to outsource some drug assessment work to private firms

The Medicines and Healthcare products Regulatory Agency said that three companies have been given contracts to provide assessments of clinical and non-clinical regulatory data.
An assortment of blister packs of medicines

The Medicines and Healthcare products Regulatory Agency (MHRA) has awarded contracts to three private companies, in what it says are efforts to speed up the process of drug assessments.

Three contracts have been awarded for pharmaceutical assessment (a value of £6m including VAT), medical assessment (a value of £4.8m including VAT) and non-clinical assessment (a value of £1.2m including VAT).

According to a tender notice for the contracts, published in July 2026, the MHRA plans to “add to its traditional in-house expertise through the establishment of additional sources of both capacity and capability”.

The contract work would involve “assessments of complex clinical and non-clinical regulatory data and provide carefully evidenced judgements within an MHRA assessment and quality assurance framework”, it added.

In a contract award notice published on 29 October 2026, the MHRA announced that the three companies that had been awarded the contracts were Iqvia Ltd (pharmaceutical assessment and non-clinical assessment), Parexel International Ltd (pharmaceutical assessment, medical assessment and non-clinical assessment) and Pharmora Ltd (medical assessment and non-clinical assessment).

The contracts are expected to run from November 2026 until November 2029, it said.

Julian Beach, executive director of operations at the MHRA, said: “We are committed to providing a timely, predictable, and effective regulatory service while maintaining the standards patients, industry and the public expect.

“These contracts will provide additional capacity as part of a flexible resourcing model that allows us to respond to unexpected peaks in demand and maintain timely regulatory assessments. The additional external capacity will complement rather than replace our in-house expertise, with MHRA retaining regulatory oversight of the work. Clear conflict of interest and confidentially requirements will be the cornerstone of this activity.

“Alongside this, we are continuing to strengthen our in-house resource, with the aim of balancing the need for external capacity long term.”

Commenting on the award of the contracts, Mark Samuels, chief executive of Medicines UK, said: “The MHRA has been very successful in the past two years in removing licensing backlogs and then improving licensing times to the best in a decade for the approval of new generic and biosimilar medicines.

“That success has led to MHRA receiving progressively more applications. This is positive for enabling generic competition and strengthening resilience of supply by more companies entering the market.

“To meet this challenge of increasing demand, we welcome MHRA taking new approaches to increase its capacity in addition to continue recruiting, training and developing its own assessors.”

In April 2026, legislation aimed at speeding up clinical trials came into force across the UK. Developed by the MHRA and the Health Research Authority, the legislation allows researchers to simultaneously apply for ethics and regulatory approval for new clinical trials of investigational medicinal products.

Also in April 2026, the MHRA and the National Institute for Health and Care Excellence announced that they were aligning their approval pathways as part of efforts to quicken patient access to new medicines.

Last updated
Citation
The Pharmaceutical Journal, PJ November 2026, Vol 317, No 8015;317(8015)::DOI:10.1211/PJ.2026.1.436783

    Please leave a comment 

    You may also be interested in