Regulation & Policy
Register medical devices to place on the market
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
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2772 published stories · page 1 of 185. Editor summaries with links to original reporting — see Editorial analysis for original commentary, or Latest on the hub.
Regulation & Policy
Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled "Fit-for-Purpose Rare Disease Framework Initiative". Convened by the Reagan-Udall Foundation for, and in collaboration with FDA, the meeting will focus on developing a fit-for-pur...
Regulation & Policy
Counterfeit weight loss pens worth £2 million seized by MHRA and West Midlands Police
Fake weight loss medicines worth approximately £2 million were seized last night in a raid executed by the Medicines and Healthcare products Regulatory Agency (MHRA) and West Midlands Police.
Retail & Distribution
Decision: Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients
Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.
Retail & Distribution
Telegraph is latest publisher to drop InPost for GB-wide supply via Smiths News
From October 2027 Smiths News will supply The Daily Telegraph and The Sunday Telegraph to all stores in Britain
Regulation & Policy
MHRA introduces new safeguards to strengthen antidepressant safety information following major review
New and updated patient information for antidepressant medicines to be introduced following an extensive review involving patients, families and independent experts.
Regulation & Policy
Antidepressants: new safety measures for all patients to improve communication of the risk of suicidal thoughts and behaviours and persistent sexual dysfunction
New safety measures are now being implemented to improve how the risks of suicidal thoughts and behaviours and persistent sexual dysfunction are communicated to patients taking antidepressant medications.
Regulation & Policy
Safety Public Assessment Reports
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Science & Policy
Research: Antidepressants – updated safety communications
Public Assessment Report on the review of antidepressants. How the risks of suicidal thoughts and behaviours and sexual dysfunction (where symptoms continue after stopping treatment), are communicated to patients.
Regulation & Policy
Guidance: Antidepressants: use and safety
Guidance on the use and side effects of selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs), their safety, use in pregnancy and the risk of suicidal behaviour.
Regulation & Policy
Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee (TPSAC)
The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee (TPSAC), in the Center for Tobacco Products. FDA seeks to include the views of qualified individuals on its advisory committees and there...
Regulation & Policy
We are witnessing an industrial-scale assault by hostile actors like Russia on the information environment in the UK: UK Statement at the UN First Committee
Statement by David Riley, Ambassador and Permanent Representative to the Conference on Disarmament in Geneva.
Regulation & Policy
Compass Pathways CEO: Psychedelics company will ‘go slow before we go fast’
The CEO of Compass Pathways said the company, whose psychedelic therapy is set for regulatory review this year, is prepared to “go slow before we go fast.”
Regulation & Policy
Illegal tobacco increasingly hard to spot, with some fakes in plain packaging featuring Australian health warnings
Government warned that counterfeit tobacco produced by criminal organisations in south-east Asia is becoming more sophisticatedGet our breaking news email, free app or daily news podcastThe black-market tobacco trade continues to thrive as sellers turn to counterfeit packaging...
Regulation & Policy
Former FDA officials blast DOGE as ‘one of the biggest disasters in American history’
Three former FDA chiefs criticized the DOGE cuts to the agency, saying they robbed the FDA of institutional knowledge that will take years to restore.