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Medicines Healthcare Products Regulatory Agency


Detailed guide: Breast implants and Anaplastic Large Cell Lymphoma (ALCL)

Detailed guide: Breast implants and Anaplastic Large Cell Lymphoma (ALCL)

Information for clinicians and patients.

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Detailed guide: MHRA phase I accreditation scheme

Detailed guide: MHRA phase I accreditation scheme

How to join the phase I accreditation scheme.

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Decision: Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients

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.

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Class 2 Medicines Recall: Mepacrine Hydrochloride 100 mg Tablets (Batch 85641), EL (20)A/27

Class 2 Medicines Recall: Mepacrine Hydrochloride 100 mg Tablets (Batch 85641), EL (20)A/27

BCM Specials Limited is recalling a specific batch of Mepacrine Hydroxychloride 100 mg tablets due to a number of foreign body particulates found in the containers of the API used to make it.

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Transparency data: Medicines and Healthcare products Regulatory Agency spending over £25,000: 2019 to 2020

Transparency data: Medicines and Healthcare products Regulatory Agency spending over £25,000: 2019 to 2020

Information on Medicines and Healthcare products Regulatory Agency spending over £25,000.

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Class 4 Medicines Defect Information: Depo Provera 150mg/ml Injection (1ml Vial) EL (20)A/26

Class 4 Medicines Defect Information: Depo Provera 150mg/ml Injection (1ml Vial) EL (20)A/26

Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder) has informed us of a typographical error in active ingredient stated on the label on the vial.

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Philips HeartStart XL Defibrillator/Monitor – therapy selector switch may fail (MDA/2020/018)

Philips HeartStart XL Defibrillator/Monitor – therapy selector switch may fail (MDA/2020/018)

Manufactured by Philips – the rotary therapy selector switch may fail resulting in unexpected device behaviours which could lead to a delay or failure in delivering therapy.

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Decision: Medical devices given exceptional use authorisations during the COVID 19 pandemic

Decision: Medical devices given exceptional use authorisations during the COVID 19 pandemic

List of manufacturers and their medical devices which have been granted an exemption by the MHRA

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Detailed guide: Regulatory status of equipment being used to help prevent coronavirus (COVID 19)

Detailed guide: Regulatory status of equipment being used to help prevent coronavirus (COVID 19)

There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)

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Guidance: Drug Safety Update: monthly PDF newsletter

Guidance: Drug Safety Update: monthly PDF newsletter

Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor the Commission on Human Medicines.

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Cyproterone acetate: new advice to minimise risk of meningioma

Cyproterone acetate: new advice to minimise risk of meningioma

Risk of meningioma with cyproterone acetate increases with increasing cumulative dose. Use of cyproterone is contraindicated in patients with previous or current meningioma (for all indications) and should only be considered for control of libido in severe hypersexuality or paraphilias in adult men when other interventions are inappropriate.

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Direct acting oral anticoagulants (DOACs): reminder of bleeding risk, including availability of reversal agents

Direct acting oral anticoagulants (DOACs): reminder of bleeding risk, including availability of reversal agents

Remain vigilant for signs and symptoms of bleeding complications during treatment with DOACs (apixaban, dabigatran, edoxaban, rivaroxaban), especially in patients with increased bleeding risks. Specific reversal agents are available for dabigatran (Praxbind?, idarucizumab), and apixaban and rivaroxaban (Ondexxya?, andexanet alfa).

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Letters and drug alerts sent to healthcare professionals in May 2020

Letters and drug alerts sent to healthcare professionals in May 2020

A summary of letters and drug alerts recently sent to healthcare professionals.

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Field Safety Notices   22 June to 26 June 2020

Field Safety Notices 22 June to 26 June 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 22 June to 26 June 2020

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Philips Respironics V60 ventilator – potential unexpected shutdown leading to complete loss of ventilation (MDA/2020/017)

Philips Respironics V60 ventilator – potential unexpected shutdown leading to complete loss of ventilation (MDA/2020/017)

Manufactured by Philips Respironics – sudden loss of power due to component failure, which may not always be accompanied by an alarm or visual warning.

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Chloroquine and Hydroxychloroquine not licensed for coronavirus (COVID 19) treatment

Chloroquine and Hydroxychloroquine not licensed for coronavirus (COVID 19) treatment

Recent media reports have suggested that chloroquine can protect patients from coronavirus or treat COVID-19, the illness caused by a coronavirus.

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Green light for COVID 19 trial recruitment

Green light for COVID 19 trial recruitment

The MHRA has approved the recruitment of further participants for a clinical trial by the University of Oxford

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Green light for COVID 19 trial recruitment

Green light for COVID 19 trial recruitment

The MHRA has approved the recruitment of further participants for a clinical trial by the University of Oxford

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Official Statistics: Early access to medicines scheme applications: pending, refused, granted

Official Statistics: Early access to medicines scheme applications: pending, refused, granted

The number of applications pending, refused and granted for the early access to medicines scheme (EAMS).

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Guidance: How tests and testing kits for coronavirus (COVID 19) work

Guidance: How tests and testing kits for coronavirus (COVID 19) work

The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.

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Transparency data: Medicines and Healthcare products Regulatory Agency Senior Officials' expenses from October to December 2018

Transparency data: Medicines and Healthcare products Regulatory Agency Senior Officials' expenses from October to December 2018

Business expenses incurred by Medicines and Healthcare products Regulatory Agency (MHRA) senior officials' between October to December 2018 (quarter 3).

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Transparency data: Medicines and Healthcare products Regulatory Agency senior officials' expenses from January to March 2019

Transparency data: Medicines and Healthcare products Regulatory Agency senior officials' expenses from January to March 2019

Business expenses incurred by Medicines and Healthcare products Regulatory Agency (MHRA) senior officials' between January to March 2019 (quarter 4).

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Decision: Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients

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.

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Detailed guide: MHRA phase I accreditation scheme

Detailed guide: MHRA phase I accreditation scheme

How to join the phase I accreditation scheme.

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Decision: Early access to medicines scheme (EAMS) scientific opinion: Raxone to treat the decline of respiratory function in patients with Duchenne Muscular Dystrophy

Decision: Early access to medicines scheme (EAMS) scientific opinion: Raxone to treat the decline of respiratory function in patients with Duchenne Muscular Dystrophy

Renewal of EAMS scientific opinion issued to Santhera Pharmaceuticals for Raxone to treat the decline of respiratory function in patients with Duchenne Muscular Dystrophy, including the public assessment report.

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Decision: Atezolizumab in combination with bevacizumab for the treatment of adult patients with unresectable hepatocellular carcinoma who have received no prior systemic therapy

Decision: Atezolizumab in combination with bevacizumab for the treatment of adult patients with unresectable hepatocellular carcinoma who have received no prior systemic therapy

EAMS scientific opinion given to Roche Products Limited for atezolizumab in combination with bevacizumab for the treatment of adult patients with unresectable hepatocellular carcinoma who have received no prior systemic therapy

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Field Safety Notices 15 to 19 June 2020

Field Safety Notices   15 to 19 June 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 15 to 19 June 2020

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Detailed guide: Register as a manufacturer to sell medical devices

Detailed guide: Register as a manufacturer to sell medical devices

Register a manufacturer or authorised representative (agent) for a manufacturer, to sell medical devices, including in vitro diagnostic (IVD) medical devices.

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Detailed guide: E cigarettes: regulations for consumer products

Detailed guide: E cigarettes: regulations for consumer products

Guidance on how to get an e-cigarette on the market in the UK, including the notification scheme and reporting problems with e-cigarettes.

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Detailed guide: Apply for the early access to medicines scheme (EAMS)

Detailed guide: Apply for the early access to medicines scheme (EAMS)

Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.

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Guidance: Urogynaecological mesh implants

Guidance: Urogynaecological mesh implants

Information for the public and healthcare professionals to support shared decision making in the treatment of stress urinary incontinence and pelvic organ prolapse.

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Guidance: Urogynaecological mesh implants

Guidance: Urogynaecological mesh implants

Information for the public and healthcare professionals to support shared decision making in the treatment of stress urinary incontinence and pelvic organ prolapse.

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Detailed guide: Exemptions from Devices regulations during the coronavirus (COVID 19) outbreak

Detailed guide: Exemptions from Devices regulations during the coronavirus (COVID 19) outbreak

How to get fast-track approval of medical devices during COVID-19.

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Philips HeartStart MRx Monitor/Defibrillators may fail to deliver therapy without alerting the user to a fault in the event of internal damage (MDA/2020/016)

Philips HeartStart MRx Monitor/Defibrillators   may fail to deliver therapy without alerting the user to a fault in the event of internal damage (MDA/2020/016)

The Philips HeartStart MRx Monitor/Defibrillator MRx may fail to identify a fault and alert the user in the event of internal damage suffered during a drop or due to severe mechanical shock.

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Press release: MHRA suspends recruitment to COVID 19 hydroxychloroquine trials

Press release: MHRA suspends recruitment to COVID 19 hydroxychloroquine trials

The Medicines and Healthcare products Regulatory Agency (MHRA) has instructed UK clinical trialists using hydroxychloroquine to treat or prevent coronavirus (COVID-19) to suspend recruitment of further participants.

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Detailed guide: Opportunities for patients and the public to be involved in the work of the MHRA

Detailed guide: Opportunities for patients and the public to be involved in the work of the MHRA

How we engage and involve patients and the public in our regulatory decision-making.

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Detailed guide: Opportunities for patients and the public to be involved in the work of the MHRA

Detailed guide: Opportunities for patients and the public to be involved in the work of the MHRA

How we engage and involve patients and the public in our regulatory decision-making.

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Consultation outcome: How should we engage and involve patients and the public in our work

Consultation outcome: How should we engage and involve patients and the public in our work

Work is ongoing to address the comments and feedback from respondents to the consultation. Publication of our report on the consultation has been delayed in light of the Agency’s response during the ongoing coronavirus situation.

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Field Safety Notices 08 to 12 June 2020

Field Safety Notices   08 to 12 June 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 08 to 12 June 2020

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Decision: Advertising investigations: May 2020

Decision: Advertising investigations: May 2020

Decisions made by MHRA following investigations into complaints about advertising for licensed medicines.

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Guidance: How tests and testing kits for coronavirus (COVID 19) work

Guidance: How tests and testing kits for coronavirus (COVID 19) work

The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.

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Decision: Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients

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.

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Decision: Marketing authorisations granted in May 2020

Decision: Marketing authorisations granted in May 2020

Marketing authorisations granted in May 2020

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Decision: Parallel import licenses granted in May 2020

Decision: Parallel import licenses granted in May 2020

Parallel import licenses granted in May 2020

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Corporate report: Medicines and Healthcare products Regulatory Agency Business Plan 2020 to 2021

Corporate report: Medicines and Healthcare products Regulatory Agency Business Plan 2020 to 2021

Third annual business plan to deliver the Medicines and Healthcare products Regulatory Agency’s Corporate Plan 2018-23

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