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Medicines And Healthcare Products Regulatory Agency


Losing GSI – MHRA emails are changing

Losing GSI – MHRA emails are changing

From 10 April, we are removing .gsi from our email addresses.

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A new way to pay

A new way to pay

Paying for medicines licences, clinical trials and clinical investigations is changing from 1 April the Medicines and Healthcare products Regulatory Agency (MHRA) announced.

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New essential Orange and Green Guides 2017 – out now

New essential Orange and Green Guides 2017 – out now

The Medicines and Healthcare products Regulatory Agency has launched its latest guide of UK pharmaceutical regulations, EU directives and guidance.

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New MedRegs blog

New MedRegs blog

MHRA has launched an official blog providing expert insight into the latest regulatory thinking and all aspects of medicines regulation.

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MHRA launch 'DMAA Week of Action'

MHRA launch 'DMAA Week of Action'

MHRA has launched a ‘Week of Action’ to improve awareness of unlicensed medicines containing the potentially dangerous ingredient DMAA.

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Standards for biological medicines   understanding them and how they make a difference

Standards for biological medicines understanding them and how they make a difference

The quality of biological medicines is assured by biological standards held by the British Pharmacopoeia (BP) and the National Institute for Biological Standards and Control (NIBSC)

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#FakeMeds in 2017: New Year, Same Danger

#FakeMeds in 2017: New Year, Same Danger

In a New Year with new beginnings, the dangers of fake and unlicensed medical products remain the same. We continue our campaign against fake and unlicensed medical products in 2017.

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Agency highlights 2016

Agency highlights 2016

Looking back at what the Medicines and Healthcare products Regulatory Agency has achieved over the last year.

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Count down to Christmas with the FakeMeds advent calendar

Count down to Christmas with the FakeMeds advent calendar

MHRA are revealing a different fact about the issue of fake and unlicensed medical products every day in December leading up to Christmas.

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MHRA leading European action to reinforce market surveillance of medical devices to protect public health

MHRA leading European action to reinforce market surveillance of medical devices to protect public health

The Medicines and Healthcare products Regulatory Agency (MHRA) has officially launched the Joint Action on Market Surveillance of Medical Devices.

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Teva levothyroxine tablets: re entry to market and introduction of new tablet strengths

Teva levothyroxine tablets: re entry to market and introduction of new tablet strengths

Following extensive changes to the formulation and manufacture of levothyroxine tablets by Teva, the Commission on Human Medicines (CHM) is now reassured that Teva has demonstrated an acceptable level of efficacy and safety to allow their levothyroxine tablets to re-enter the market. Additional tablet strengths have also been introduced, to improve precision of dosing.

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MHRA statement on products containing Cannabidiol (CBD)

MHRA statement on products containing Cannabidiol (CBD)

The Medicines and Healthcare products Regulatory Agency has reviewed the classification of products containing CBD and found them to meet the definition of a medicinal product.

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Statement on Statins

Statement on Statins

Statement from Medicines and Healthcare products Regulatory Agency on the risks and benefits of statins.

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MHRA Customer Service   phone line not working

MHRA Customer Service phone line not working

MHRA are experiencing technical difficulties with the customer service hotline.

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Spaces filling fast for MHRA's GCPGLP Symposium

Spaces filling fast for MHRA's GCPGLP Symposium

If you have not yet booked your place in September's conference, book now to avoid disappointment.

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Know what you're buying!

Know what you're buying!

Eight tips for buying medicines and medical devices online safely

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MHRA urges people to be cautious when buying sports supplements

MHRA urges people to be cautious when buying sports supplements

A review into the sports supplement industry ahead of the Rio 2016 Olympic games shows the sport supplement industry is improving.

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MHRA urges people to be cautious when buying sports supplements

MHRA urges people to be cautious when buying sports supplements

A review into the sports supplement industry ahead of the Rio 2016 Olympic games shows the sport supplement industry is improving.

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Clinical Trials Regulations – have your say

Clinical Trials Regulations – have your say

The Medicines and Healthcare products Regulatory Agency invites interested parties to provide feedback on Clinical Trial Regulation guidance documents.

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MHRA GxP Data Integrity Definitions and Guidance for Industry

MHRA GxP Data Integrity Definitions and Guidance for Industry

MHRA has produced draft GxP data integrity guidance for industry and we welcome your comments

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Volunteers wanted to help determine the future of pharmacovigilance

Volunteers wanted to help determine the future of pharmacovigilance

Web-RADR: Recognising Adverse Drug Reactions is running a survey for healthcare providers, patients, and consumers of medicines to help develop the next generation of online side-effect reporting software.

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Medicines and Healthcare products Regulatory Agency statement on the outcome of the EU referendum

Medicines and Healthcare products Regulatory Agency statement on the outcome of the EU referendum

The Agency's response to the outcome of the EU referendum.

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Interrogating research to protect public health

Interrogating research to protect public health

Part of the work of the medicines and medical device regulator involves looking at existing research to help reach conclusions about potential and emerging issues with devices.

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Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug device Combination Products

Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug device Combination Products

MHRA has produced draft guidance for medical devices including drug-device combination products and we welcome your comments

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MHRA information on TPP and QRISK®2

MHRA information on TPP and QRISK®2

The Medicines and Healthcare products Regulatory Agency (MHRA) is investigating an issue involving a digital calculator used by some GPs to assess the potential risk of heart disease in patients.

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Ground breaking WEB RADR project marks mid point

Ground breaking WEB RADR project marks mid point

The MHRA-led WEB-RADR project held its General Assembly in London on April 21

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MHRA responds to misleading Sunday Post article

MHRA responds to misleading Sunday Post article

MHRA issue letter to the editor of the Sunday Post in response to ‘Deadly toll of dodgy NHS gear. Thousands killed or seriously injured by faulty equipment’ article.

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MHRA contributing to the global fight against Zika

MHRA contributing to the global fight against Zika

The WHO has declared Zika a "public health emergency of international concern." MHRA is part of the global coalition responding to the outbreak.

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Medicines and Healthcare products Regulatory Agency: board meetings in public session in 2016

Medicines and Healthcare products Regulatory Agency: board meetings in public session in 2016

The Agency is holding a second public session of its board meeting. Register now to attend the meeting in April.

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Medicines marketing authorisation: Change of ownership application

Medicines marketing authorisation: Change of ownership application

MHRA are making improvements to the change of ownership application (COA) process for medicines marketing authorisations (MA).

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New rules to help fight falsified medicines

New rules to help fight falsified medicines

New rules approved by the European Parliament will require safety features on the packaging of medicines at risk of falsification

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Register now for joint MHRA and BIA conference

Register now for joint MHRA and BIA conference

4 May 2016: Conference on accelerated development and access to innovative medicines for patients.

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Become a pharmaceutical assessor at MHRA

Become a pharmaceutical assessor at MHRA

MHRA has launched a campaign highlighting the work of pharmaceutical assessors and the role they play in protecting public health.

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Thousands of potentially dangerous slimming pills seized in raid

Thousands of potentially dangerous slimming pills seized in raid

MHRA investigators seize more than 28,000 unlicensed slimming pills in Manchester area.

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Flu vaccine: myths and the facts behind them

Flu vaccine: myths and the facts behind them

Scientists at the National Institute for Biological Standards and Control (NIBSC) dispel some of the common myths about flu vaccines.

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Medicines and Healthcare products Regulatory Agency board meetings: pilot of public sessions

Medicines and Healthcare products Regulatory Agency board meetings: pilot of public sessions

The agency will pilot holding board meetings in public in 2016.

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Making the case for UK medicines manufacturing

Making the case for UK medicines manufacturing

2 March 2016: joint MHRA and ABPI training event

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Clinical Practice Research Datalink (CPRD) website survey

Clinical Practice Research Datalink (CPRD) website survey

CPRD is planning to redevelop its website and is looking for feedback on how the current website is used.

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E learning modules have now moved to NAMDET

E learning modules have now moved to NAMDET

These modules are now available online through the National Association of Medical Device Educators and Trainers (NAMDET).

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Joint NHSE and MHRA conference: Developing Synergies, Promoting Safety

Joint NHSE and MHRA conference: Developing Synergies, Promoting Safety

8 February 2016: conference for medical device safety officers (MDSO) and medication safety officers (MSO) to explore key themes in patient safety.

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Agency highlights 2015

Agency highlights 2015

Looking back at what the Medicines and Healthcare products Regulatory Agency has achieved over the last year.

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Changes to MHRA bank details

Changes to MHRA bank details

Payment details for MHRA bank account will change from 18 January.

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Over 500 UK patients gain early access to new melanoma treatment

Over 500 UK patients gain early access to new melanoma treatment

Patients with advanced melanoma are among the first in the world to access pembrolizumab through the early access to medicines scheme (EAMS).

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MHRA Hot Topics in Advertising: Prescription Medicines Seminar

MHRA Hot Topics in Advertising: Prescription Medicines Seminar

23 February 2016: registration now open for hot topics seminar covering key topics on advertising and promotion.

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Joint MHRA and DIA training: Excellence in Pharmacovigilance

Joint MHRA and DIA training: Excellence in Pharmacovigilance

1 to 5 February 2016: This 5-day course will cover European clinical pre and post-Marketing safety regulatory requirements.

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