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.
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.
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.
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.
Regulation & Policy
FDA Seeks Two New Voting Members for Tobacco Advisory Committee
The FDA also announced four new voting members: Holger Behrsing, Kim “Skip” Murray, Margaret Nolan, and Andrew A. Strasser. The post FDA Seeks Two New Voting Members for Tobacco Advisory Committee first appeared on Tobacco Reporter.
Regulation & Policy
Malawi Extends Tobacco Grower Registration Deadline
The country has an estimated 191,000 tobacco growers, of whom 49,229 had registered under the KYG system as of Oct. 12. The post Malawi Extends Tobacco Grower Registration Deadline first appeared on Tobacco Reporter.
Regulation & Policy
PMI to Report Third-Quarter Results Oct. 21
PMI will release its 2026 third-quarter and first nine-month financial results at 7 a.m. on Oct. 21, followed by a live audio webcast at 9 a.m. The post PMI to Report Third-Quarter Results Oct. 21 first appeared on Tobacco Reporter.