New medicines review process under NHS 10-Year Plan emerges

Pharma companies in the UK are being invited to register their new medicines with both the MHRA and NICE at the same time, as part of a push to reduce regulatory review times by three to six months.

The joint information sharing agreement between the medicines regulatory authority and reimbursement agency was first disclosed under the recently published NHS 10-Year Plan and aims to deliver simultaneous decisions on whether new medicines can be used by the health service.

NICE said in a statement that the joint reviews are part of a drive towards smarter regulation of the pharma industry by the government, which has the target of cutting administrative costs for businesses by 25%.

Companies wishing to make use of the dual pathway should register their products on UK PharmaScan, a database of information on new medicines, indications, and formulations in the pipeline, at least three years before they intend to file for approval.

The Association of the British Pharmaceutical Industry (ABPI) made a somewhat guarded response to the announcement, with chief executive Richard Torbett saying he welcomed it as "one of many necessary improvements in the UK health and life sciences ecosystem."

The ABPI has expressed some strong reservations about the 10-year plan, notably the lack of a commitment to increase the UK's investment in medicines, proposals for a national formulary, and a move to retire guidance for existing medicines that NICE considers offer poor value for money.

Nevertheless, Torbett welcomed the initiative, saying a streamlined approval process "will allow both agencies to give patients earlier and equitable access to the innovative medicines needed to improve UK health outcomes."

MHRA chief executive Lawrence Tallon said: "We are working in closer partnership with NICE to build a faster and more efficient regulatory system, designed to accelerate UK market entry and deliver innovative, life-changing treatments to NHS patients faster."

He added: "This marks an important step in delivering smarter regulation – strengthening the UK's global life sciences offer and reinforcing our position as an attractive destination for innovation and international investment."

Digital experts sought by MHRA

In other news this week, the MHRA has begun recruiting for new, highly skilled digital and data roles at its newly launched digital hub in Leeds, announced in June, as part of a drive to modernise the regulation of medicines and medical devices in the UK.

The new roles will support the delivery of a "modern, secure infrastructure" for clinical trials, safety monitoring, and real-time data use, said the regulator.

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