GB would get enabling powers for its own device licensing route under Health Bill amendments. https://www.mattheneus.com/editorial/mhra-health-bill-amendments-device-licensing-information-sharing-2026-09-01 #HTA #RegulatoryAffairs
September 29, 2026 at 8:02 AM
GB would get enabling powers for its own device licensing route under Health Bill amendments. https://www.mattheneus.com/editorial/mhra-health-bill-amendments-device-licensing-information-sharing-2026-09-01 #HTA #RegulatoryAffairs
Previously, the UK operated under the European Medicines Agency (EMA). Now, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) operates independently.
And this leads to a "divergence" penalty:
And this leads to a "divergence" penalty:
September 29, 2026 at 7:44 AM
Previously, the UK operated under the European Medicines Agency (EMA). Now, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) operates independently.
And this leads to a "divergence" penalty:
And this leads to a "divergence" penalty:
Lord's Mark Industries' AI-Powered Dialysis Ecosystem Secures MHRA Registration, Opens UK & Allied Market Gateway
->Mint | More on "AI-powered dialysis ecosystem innovation" at BigEarthData.ai | #ecosystem
->Mint | More on "AI-powered dialysis ecosystem innovation" at BigEarthData.ai | #ecosystem
Lord's Mark Industries' AI-Powered Dialysis Ecosystem Secures MHRA Registration, Opens UK & Allied Market Gateway
From an Indian innovation to a global renal-care opportunity: Lord’s Mark Industries takes its AI-powered dialysis ecosystem closer to international markets. In a landmark moment for India’s medical technology sector, Lord’s Mark Industries Limited, through its healthcare and med-tech platform, has secured registration with the Medicines & Healthcare products Regulatory Agency (MHRA), London, UK, for its haemodialysis system, marking a major step towards taking its AI-powered dialysis technology and integrated renal-care ecosystem to the UK and UK-allied markets. The company positions this milestone as India’s first and the world’s first such AI-powered dialysis ecosystem to secure the regulatory milestone at this pace, and as the first Indian company to achieve this milestone in the context of the India-UK Free Trade Agreement (FTA). The registration covers Renalyx Health Systems Pvt. Ltd. as a manufacturer, with its haemodialysis system for institutional and home use registered under GMDN Code 58131. Lord’s Mark Industries Limited will start exporting its machine to Uk and Uk ally countries from early January 2027. What began as a Made-in-India medical technology is now stepping onto the global healthcare stage. Lord’s Mark Industries is taking its world-first AI-powered integrated dialysis ecosystem beyond India, with the UK emerging as a...
www.livemint.com
September 29, 2026 at 5:13 AM
Depeche Mode released their sixth studio album "Music for the Masses" on this day in 1987.
Released as a single – Strangelove
#DepecheMode #OnThisDay #OTD #MusicSky
youtube.com/watch?v=MHRa...
Released as a single – Strangelove
#DepecheMode #OnThisDay #OTD #MusicSky
youtube.com/watch?v=MHRa...
Depeche Mode - Strangelove (Official Video)
YouTube video by DepecheModeVEVO
youtube.com
September 28, 2026 at 10:00 PM
Depeche Mode released their sixth studio album "Music for the Masses" on this day in 1987.
Released as a single – Strangelove
#DepecheMode #OnThisDay #OTD #MusicSky
youtube.com/watch?v=MHRa...
Released as a single – Strangelove
#DepecheMode #OnThisDay #OTD #MusicSky
youtube.com/watch?v=MHRa...
The MHRA National Commission into the Regulation of AI in Healthcare published its recommendations for a UK regulatory framework.
Focus areas:
🔹 Continuous, real-world monitoring of AI tools
🔹 Transparency & patient involvement in policy
🔹 Enhanced MHRA enforcement powers
➡️ buff.ly/tNpV6tG
Focus areas:
🔹 Continuous, real-world monitoring of AI tools
🔹 Transparency & patient involvement in policy
🔹 Enhanced MHRA enforcement powers
➡️ buff.ly/tNpV6tG
September 28, 2026 at 11:02 AM
The MHRA National Commission into the Regulation of AI in Healthcare published its recommendations for a UK regulatory framework.
Focus areas:
🔹 Continuous, real-world monitoring of AI tools
🔹 Transparency & patient involvement in policy
🔹 Enhanced MHRA enforcement powers
➡️ buff.ly/tNpV6tG
Focus areas:
🔹 Continuous, real-world monitoring of AI tools
🔹 Transparency & patient involvement in policy
🔹 Enhanced MHRA enforcement powers
➡️ buff.ly/tNpV6tG
A big BUT:
"But there are also concerns about AI models making wrong decisions as a result of biases in the patient data used to train them, and incorrect medical advice being given by AI chatbots."
www.bbc.co.uk/news/article...
"But there are also concerns about AI models making wrong decisions as a result of biases in the patient data used to train them, and incorrect medical advice being given by AI chatbots."
www.bbc.co.uk/news/article...
UK needs new laws for AI in healthcare, says watchdog
The technology will soon be routinely used within the NHS, MHRA chief Lawrence Tallon tells the BBC.
www.bbc.co.uk
September 28, 2026 at 9:26 AM
A big BUT:
"But there are also concerns about AI models making wrong decisions as a result of biases in the patient data used to train them, and incorrect medical advice being given by AI chatbots."
www.bbc.co.uk/news/article...
"But there are also concerns about AI models making wrong decisions as a result of biases in the patient data used to train them, and incorrect medical advice being given by AI chatbots."
www.bbc.co.uk/news/article...
The UK MHRA has published guidance enabling pharmaceutical manufacturers to submit non-safety-critical changes to drug labels and Patient Inform…
#Druglabelling #MHRA #Patientinformation #Pharmaceuticalregulation #Qualityassurance
#Druglabelling #MHRA #Patientinformation #Pharmaceuticalregulati…
#Druglabelling #MHRA #Patientinformation #Pharmaceuticalregulation #Qualityassurance
#Druglabelling #MHRA #Patientinformation #Pharmaceuticalregulati…
UK Regulator Streamlines Drug Label Changes
The UK MHRA has published guidance enabling pharmaceutical manufacturers to submit non-safety-critical changes to drug labels and Patient Inform…
#Druglabelling #MHRA #Patientinformation #Pharmaceuticalregulation #Qualityassurance
news.gmj.ge
September 28, 2026 at 3:26 AM
The UK MHRA has published guidance enabling pharmaceutical manufacturers to submit non-safety-critical changes to drug labels and Patient Inform…
#Druglabelling #MHRA #Patientinformation #Pharmaceuticalregulation #Qualityassurance
#Druglabelling #MHRA #Patientinformation #Pharmaceuticalregulati…
#Druglabelling #MHRA #Patientinformation #Pharmaceuticalregulation #Qualityassurance
#Druglabelling #MHRA #Patientinformation #Pharmaceuticalregulati…
Five markets. Five different rulebooks.
Germany: EU-GMP required.
Australia: TGA-aligned per shipment.
UK: MHRA authorization plus Home Office license.
Israel: among the world's most rigorous traceability requirements.
Thailand: actively writing its framework as suppliers arrive.
The suppliers win
Germany: EU-GMP required.
Australia: TGA-aligned per shipment.
UK: MHRA authorization plus Home Office license.
Israel: among the world's most rigorous traceability requirements.
Thailand: actively writing its framework as suppliers arrive.
The suppliers win
September 27, 2026 at 5:03 PM
Five markets. Five different rulebooks.
Germany: EU-GMP required.
Australia: TGA-aligned per shipment.
UK: MHRA authorization plus Home Office license.
Israel: among the world's most rigorous traceability requirements.
Thailand: actively writing its framework as suppliers arrive.
The suppliers win
Germany: EU-GMP required.
Australia: TGA-aligned per shipment.
UK: MHRA authorization plus Home Office license.
Israel: among the world's most rigorous traceability requirements.
Thailand: actively writing its framework as suppliers arrive.
The suppliers win
Also in the UK mktg authorisation has been reviewed and suspended. www.gov.uk/government/n...
My thoughts are with patients. Personally I hope more doctors leverage on the positive anti-inflammatory role of natural myokines nudging big pharma research towards more sustainable endeavours. Love life!
My thoughts are with patients. Personally I hope more doctors leverage on the positive anti-inflammatory role of natural myokines nudging big pharma research towards more sustainable endeavours. Love life!
MHRA concludes review of Avacopan Vifor following reassessment of benefit-risk balance
Avacopan Vifor is used in the treatment of some rare autoimmune diseases affecting small blood vessels.
www.gov.uk
September 27, 2026 at 8:32 AM
Also in the UK mktg authorisation has been reviewed and suspended. www.gov.uk/government/n...
My thoughts are with patients. Personally I hope more doctors leverage on the positive anti-inflammatory role of natural myokines nudging big pharma research towards more sustainable endeavours. Love life!
My thoughts are with patients. Personally I hope more doctors leverage on the positive anti-inflammatory role of natural myokines nudging big pharma research towards more sustainable endeavours. Love life!
Going to be a struggle. AI technology crosses all boundaries, including international. UK Government can set a national regulatory framework with oversight maybe in DSIT and individual regulators like MHRA taking responsibility within that. But how International? PM tried at U.N. but ran into Trump
September 27, 2026 at 7:18 AM
Going to be a struggle. AI technology crosses all boundaries, including international. UK Government can set a national regulatory framework with oversight maybe in DSIT and individual regulators like MHRA taking responsibility within that. But how International? PM tried at U.N. but ran into Trump
62.8s. Description carries the precision: 3/1,357 is patient-CENTRED outcomes (34 had registered trials), 510(k) equivalence mechanism, EU AI Act medical-device obligations deferred to 2 Aug 2028, UK MHRA ne...
https://presentofai.com/shorts/ai-medical-devices
https://youtube.com/shorts/-zam65vIHgI
https://presentofai.com/shorts/ai-medical-devices
https://youtube.com/shorts/-zam65vIHgI
September 27, 2026 at 6:20 AM
62.8s. Description carries the precision: 3/1,357 is patient-CENTRED outcomes (34 had registered trials), 510(k) equivalence mechanism, EU AI Act medical-device obligations deferred to 2 Aug 2028, UK MHRA ne...
https://presentofai.com/shorts/ai-medical-devices
https://youtube.com/shorts/-zam65vIHgI
https://presentofai.com/shorts/ai-medical-devices
https://youtube.com/shorts/-zam65vIHgI
Depeche Mode - Strangelove (Official Video)
YouTube video by DepecheModeVEVO
www.youtube.com
September 26, 2026 at 3:28 PM
Yes.That should be an MHRA regulatory requirement within a lifecycle-based, system-wide framework.
But if AI creates risks that cross institutional boundaries, regulation based entirely on existing institutional boundaries may itself be the problem.
But if AI creates risks that cross institutional boundaries, regulation based entirely on existing institutional boundaries may itself be the problem.
September 26, 2026 at 12:06 PM
Yes.That should be an MHRA regulatory requirement within a lifecycle-based, system-wide framework.
But if AI creates risks that cross institutional boundaries, regulation based entirely on existing institutional boundaries may itself be the problem.
But if AI creates risks that cross institutional boundaries, regulation based entirely on existing institutional boundaries may itself be the problem.
13 years of investigation!
Resulted in a three-year prison sentence suspended for three years.
Superficially seems to have been a VERY long investigation - how could it take that long?
www.gov.uk/government/n...
Resulted in a three-year prison sentence suspended for three years.
Superficially seems to have been a VERY long investigation - how could it take that long?
www.gov.uk/government/n...
MHRA welcomes sentencing after fraud convictions over falsely certified medical devices
Following convictions related to falsely certified medical devices, the MHRA has welcomed the sentencing in a long-running enforcement investigation.
www.gov.uk
September 26, 2026 at 10:58 AM
13 years of investigation!
Resulted in a three-year prison sentence suspended for three years.
Superficially seems to have been a VERY long investigation - how could it take that long?
www.gov.uk/government/n...
Resulted in a three-year prison sentence suspended for three years.
Superficially seems to have been a VERY long investigation - how could it take that long?
www.gov.uk/government/n...
MHRA opens a call for evidence on AI for medicines safety, reaching beyond ADMET into validation and governance. https://www.mattheneus.com/editorial/mhra-beyond-admet-ai-medicines-safety-call-for-evidence-2026-09-22 #HTA #RegulatoryAffairs #RWE
September 25, 2026 at 8:00 PM
MHRA opens a call for evidence on AI for medicines safety, reaching beyond ADMET into validation and governance. https://www.mattheneus.com/editorial/mhra-beyond-admet-ai-medicines-safety-call-for-evidence-2026-09-22 #HTA #RegulatoryAffairs #RWE
The MHRA is proposing a faster scientific advice route and fee rebates from April 2027, reshaping early regulatory engagement budgets. #HTA #RegulatoryAffairs #Pharma https://www.mattheneus.com/editorial/mhra-statutory-fees-2027-scientific-advice-accelerated-route-rebate-proposals
September 25, 2026 at 4:00 PM
The MHRA is proposing a faster scientific advice route and fee rebates from April 2027, reshaping early regulatory engagement budgets. #HTA #RegulatoryAffairs #Pharma https://www.mattheneus.com/editorial/mhra-statutory-fees-2027-scientific-advice-accelerated-route-rebate-proposals
Advice has been issued to care home staff and other healthcare professionals about the need to use a filter when administering parenteral nutrition following ‘a number of adverse incidents’.
#parenteralnutrition #carehomes #MHRA
www.nursinginpractice.com/clinical/nut...
#parenteralnutrition #carehomes #MHRA
www.nursinginpractice.com/clinical/nut...
Filters should be used when administering parenteral nutrition, MHRA states
Advice has been issued to care home staff about using a filter when administering parenteral nutrition following ‘adverse incidents’.
www.nursinginpractice.com
September 25, 2026 at 3:04 PM
Advice has been issued to care home staff and other healthcare professionals about the need to use a filter when administering parenteral nutrition following ‘a number of adverse incidents’.
#parenteralnutrition #carehomes #MHRA
www.nursinginpractice.com/clinical/nut...
#parenteralnutrition #carehomes #MHRA
www.nursinginpractice.com/clinical/nut...
Quality credentials: Certifications enable consistent outcomes, not just badges. #Micronclean is independently certified: ISO 9001, 14001, 13485, ISO 17025 (UKAS), RABC, and MHRA GMP (Assured Micro). Supporting supplier due diligence. Call +44(0)1754 767377, visit micronclean.com
September 25, 2026 at 12:30 PM
Quality credentials: Certifications enable consistent outcomes, not just badges. #Micronclean is independently certified: ISO 9001, 14001, 13485, ISO 17025 (UKAS), RABC, and MHRA GMP (Assured Micro). Supporting supplier due diligence. Call +44(0)1754 767377, visit micronclean.com
In a context of increasing private use as you say, as well as aggressive and barely regulated PR via social media & influencers, and the rhetorical power of 'innovation' vs 'blockers/the blob'.
MHRA being told to prioritise 'innovation' doesn't send a great signal.
MHRA being told to prioritise 'innovation' doesn't send a great signal.
September 25, 2026 at 11:27 AM
In a context of increasing private use as you say, as well as aggressive and barely regulated PR via social media & influencers, and the rhetorical power of 'innovation' vs 'blockers/the blob'.
MHRA being told to prioritise 'innovation' doesn't send a great signal.
MHRA being told to prioritise 'innovation' doesn't send a great signal.
Maybe somebody could remind the government of the MHRA's own position paper on the treatment of other rare conditions?
screedvault.neocities.org/post/2026061...
screedvault.neocities.org/post/2026061...
The Pathways trial in context: How are other rare conditions treated in the NHS?
TLDR: An MHRA position paper offers a glimpse into the context in which the treatment of trans children sits within the governmental and NHS medical framework, reveals the wider framework in which the...
screedvault.neocities.org
September 24, 2026 at 6:30 PM
Maybe somebody could remind the government of the MHRA's own position paper on the treatment of other rare conditions?
screedvault.neocities.org/post/2026061...
screedvault.neocities.org/post/2026061...
🚨 URGENT: UK medicines regulator (MHRA) has issued a Class 4 alert for Gabapentin Relonchem 50mg/ml Oral Solution due to particles found in bottle…
#Gabapentin #MHRAalert #PatientSafety #Pharmaceuticalsafety #Qualitydefect
#Gabapentin #MHRAalert #PatientSafety #Pharmaceuticalsafety #Qualitydefe…
#Gabapentin #MHRAalert #PatientSafety #Pharmaceuticalsafety #Qualitydefect
#Gabapentin #MHRAalert #PatientSafety #Pharmaceuticalsafety #Qualitydefe…
MHRA issues Class 4 alert for gabapentin oral solution
🚨 URGENT: UK medicines regulator (MHRA) has issued a Class 4 alert for Gabapentin Relonchem 50mg/ml Oral Solution due to particles found in bottle…
#Gabapentin #MHRAalert #PatientSafety #Pharmaceuticalsafety #Qualitydefect
news.gmj.ge
September 24, 2026 at 1:26 PM
🚨 URGENT: UK medicines regulator (MHRA) has issued a Class 4 alert for Gabapentin Relonchem 50mg/ml Oral Solution due to particles found in bottle…
#Gabapentin #MHRAalert #PatientSafety #Pharmaceuticalsafety #Qualitydefect
#Gabapentin #MHRAalert #PatientSafety #Pharmaceuticalsafety #Qualitydefe…
#Gabapentin #MHRAalert #PatientSafety #Pharmaceuticalsafety #Qualitydefect
#Gabapentin #MHRAalert #PatientSafety #Pharmaceuticalsafety #Qualitydefe…
MHRA welcomes sentencing after fraud convictions over falsely certified medical devices
MHRA welcomes sentencing after fraud convictions over falsely certified medical devices
<img src="https://www.govwire.co.uk/og/cache/news/2738897.png"/>Following convictions related to falsely certified medical devices, the MHRA has welcomed the sentencing in a long-running enforcement investigation. | Medicines and Healthcare products Regulatory Agency.
www.govwire.co.uk
September 24, 2026 at 12:17 PM
MHRA welcomes sentencing after fraud convictions over falsely certified medical devices
#ENSC Ensysce Biosciences Phase 2 Protocol for CY200 - A Neuroplastigen for the Treatment of CRPS - Submitted to the UK MHRA
https://www.stocktitan.net/news/ENSC/ensysce-biosciences-phase-2-protocol-for-cy200-a-neuroplastigen-for-waj13m80tjeo.html?utm_source=stocktitan-bluesky&utm_medium=social
https://www.stocktitan.net/news/ENSC/ensysce-biosciences-phase-2-protocol-for-cy200-a-neuroplastigen-for-waj13m80tjeo.html?utm_source=stocktitan-bluesky&utm_medium=social
www.stocktitan.net
September 24, 2026 at 12:00 PM
#ENSC Ensysce Biosciences Phase 2 Protocol for CY200 - A Neuroplastigen for the Treatment of CRPS - Submitted to the UK MHRA
https://www.stocktitan.net/news/ENSC/ensysce-biosciences-phase-2-protocol-for-cy200-a-neuroplastigen-for-waj13m80tjeo.html?utm_source=stocktitan-bluesky&utm_medium=social
https://www.stocktitan.net/news/ENSC/ensysce-biosciences-phase-2-protocol-for-cy200-a-neuroplastigen-for-waj13m80tjeo.html?utm_source=stocktitan-bluesky&utm_medium=social