MHRA Updates Progress on Reforms in Response to Critical Findings

After receiving a less-than-favorable review on engagement with the clinical community, the UK’s Medicines and Healthcare products Regulatory Agency says it has made progress on this front — including forming an independent Devices Expert Advisory Committee and hiring clinical staff capable of peer-to-peer dialogue with healthcare leaders.

But, as the agency notes, challenges remain.

Published July 3, the MHRA report touches on 12 recommendations by Professor Terence Stephenson, chair of the General Medical Council, who led an independent team to assess the agency’s access to expert advice on devices, and found it lacking. The agency has identified the initial 14 stakeholder groups whose expertise would be needed for the DEAC, and a kickoff meeting is expected to take place this month.

The DEAC is expected to play a prominent role in helping the MHRA assume a more proactive role in building relationships and exchanging information with clinical groups within the UK. In fact, the agency already has contacted the Royal Colleges and specialist societies to help develop and manage a structured network of clinical advisers, rather than relying on an ad hoc group.

In terms of hiring clinical staff, the MHRA notes it has a full complement for the devices division — three medically trained positions and a senior nurse. In addition, the agency has developed a career pathways group to address recruitment and retention issues within the division.

However, recruitment, training and development of clinical staff remain critical challenges, the MHRA notes.

The report also touches on steps taken to support the safe introduction of innovative technologies in clinical practice, particularly in the wake of the Poly Implant Prothèse breast implant scandal (see related story). The agency says it has been active in a range of areas, including regenerative medicine and software as a medical device.

Still, work remains. “Current resource constraints severely limit our ability to provide more support and communication to companies, particularly considering the regulatory processes for novel devices and those that span the regulatory environments for both devices and pharmaceuticals, such as combination products and diagnostics supporting personalized medicine,” the agency says.

To read the full progress report, visit www.fdanews.com/07-13-15-MHRA-update.pdf. — Elizabeth Hollis