Author Archives: HM Government

From 20-24 November, MHRA is running a social media campaign to promote recognition and reporting of suspected side effects from over-the-counter medicines, as part of an EU-wide awareness week.

While medicines are safe and effective, side effects can happen, even with over-the-counter medicines. It is important the risks associated with all medicines are understood and communicated to health professionals and patients.

Potential side effects may range from a headache or sore stomach, to flu-like symptoms or just ‘feeling a bit off’ and reporting these can help regulators monitor medicines on the market and take action as appropriate.

Regulators such as MHRA rely on the reporting of suspected side effects to make sure medicines on the market are acceptably safe. Unfortunately, all reporting systems suffer from under reporting – this is why our campaign is important to both raise awareness and help strengthen the system.

SCOPE ADR Campaign

Mick Foy, Group Manager for MHRA’s Vigilance and Risk Management of Medicines division, said

The most important part of our work is making sure the medicines you and your family take are effective and acceptably safe.

Our campaign will help the public, patients and healthcare professionals report potential side effects and have confidence that their reports are making a difference.

You can help make medicines safer by reporting any suspected side effects easily and quickly online through the Yellow Card Scheme.

The campaign is part of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action project. One of its main aims is to raise awareness of national reporting systems for suspected side effects in medicines.

Notes to Editor

1. National reporting systems for the collection of suspected adverse drug reactions (commonly known as side effects) have acted as early warning systems to help identify numerous important safety issues, many of which were not recognised as being related to a particular medicine until reports were received by medicines regulators.

2. The Medicines and Healthcare products Regulatory Agency is responsible for protecting and improving the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research. The agency consists of three centres: CPRD, NIBSC and MHRA.

3. The public is advised that they should take prescription-only medicines after an appropriate consultation with their GP. Only healthcare professionals can take into account risks and benefits associated with every medicine.

4. To report a counterfeit medicine or device contact MHRA’s dedicated 24-hour hotline on 020 3080 6701, or email counterfeit@mhra.gov.uk, or write to: Counterfeits, The Intelligence Unit, MHRA, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ.

5. To report a suspected side effect from an unlicensed medicine visit the Yellow Card Scheme

6. The SCOPE Joint Action project (scopejointaction.eu) social media campaign is being taken forward through the Heads of Medicines Agencies Working Group for Communications Professionals.

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The legislation making these changes was laid in Parliament on 16 November 2017.

These changes follow on from our consultation, which received comments from 23 respondents.

As explained in the government’s response document, we have adjusted the proposals in light of the comments we received. The legislation makes the changes set out in the response document.

We will publish detailed guidance on how these fee changes will operate in practice, in due course.

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Upcoming reforms to medical radiation exposure regulations will greatly change how the Administration of Radioactive Substances Advisory Committee (ARSAC) issues approvals.

The Ionising Radiation (Medical Exposure) Regulations 2018 (IR(ME)R) will come into force in England, Scotland and Wales on 6 February 2018. A separate set of regulations applying the same licensing process will be introduced in Northern Ireland.

The new regulations will replace the current certification process for the administration of radioactive substances under The Medicines Administration Radioactive Substances 1978 Regulations, and lead to changes in the way ARSAC handles applications.

There will be a double licensing system for practitioners and employers under IR(ME)R. The new system aims to make clear the responsibilities of the employer and practitioner in administration of radioactive substances.

The deadlines for receiving applications for certification are:

• 20 December 2017 for new and additional diagnostic or therapeutic applications
• 16 January 2018 for renewal diagnostic or therapeutic applications
• 16 January 2018 for new and extensions of research site certificates

Louise Fraser, Scientific Adviser to ARSAC, said:

It’s really important that you think about what these changes could mean to you and your employer and consider what, if anything, you need to do ahead of the changes. We will be preparing further guidance and will, as ever, be on hand to assist with any queries anyone may have about the interim and new arrangements.

For more information on next steps and regular updates on deadlines please subscribe to the ARSAC email bulletin.

Under the new regulations:

• employers must hold a licence at each medical radiological installation, such as a hospital or mobile imaging service, where radioactive substances will be administered for diagnosis, treatment or research – this licence will define the range of service that can be delivered at that location
• practitioners, such as nuclear medicine physicians, must hold a licence to clinically justify exposures involving the administration of radioactive substances for diagnosis, treatment or research; a practitioner’s licence is valid anywhere they are allowed under IR(ME)R 2018 to act as a practitioner
• a practitioner will only require one licence, regardless of how many employers they work for; the scope of the licence will reflect the individual’s training and experience for procedures
• any radiation exposure involving the administration of radioactive substances at a medical radiological installation must be justified by a licensed practitioner whose employer holds an appropriate licence for that exposure, at that installation
• entitled operators can continue allowing exposures in line with justification guidelines issued by a licensed practitioner entitled at that medical radiological installation
• any current ARSAC certificates due to expire after the new regulations come into force will be considered as equal to a licence for both the practitioner and the employer until the expiry date

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I am absolutely delighted to be taking up my new role. Our remit is extensive. There are, of course, challenges and opportunities for employers, schools, training providers and academies. We are not just a funding agency – our portfolio is also about supporting citizens, schools and businesses to make informed choices about apprenticeships, skills, learning, work and careers. If we can harness the power and capability of the sector, working with our partners, we can continue to make an impact on boosting economic growth while creating opportunities for social mobility.

We stand at a crucial moment in time. Seven months into the apprenticeship levy, which has brought about much change, the sector has quickly adapted. However, I am aware there are challenges. I am keen to work with the sector as a priority to ensure continued delivery and support as we implement the apprenticeship and devolution reform requirements ahead.

There is more work to be done on understanding the needs of our providers and employers, so they understand the investment opportunities the apprenticeship levy brings and more work to be done towards the national funding formula implementation for schools. All this encompassed by the need for a relentless focus on value for money for the taxpayer.

I have already been impressed at the work, achievements and commitments of the sector, including the ambition and pride in what continues to be delivered on a daily basis. I very much look forward to meeting and working with you all in the future.

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As part of the Industrial Strategy’s aim to improve productivity and create better and higher-paying jobs across the UK, the government will:

• Work with industry to boost spending on R&D to 2.4 per cent of GDP by 2027, which could increase public and private R&D investment by as much as £80 billion over the next 10 years. We will start by making an extra investment of £2.3 billion in 2021/22, raising total public investment in R&D to £12.5 billion that year alone.

• Launch a £1.7 billion Transforming Cities Fund that will improve transport links and promote local growth within city regions, placing cities at the heart of our industrial strategy. This includes £250 million for better transport in the West Midlands.

The Prime Minister will visit the West Midlands today with the Chancellor and Business Secretary beginning a week in which the government will set out its plan for a stronger economy and fairer society.

Writing in The Times today, the Prime Minister said:

“One of my first actions as Prime Minister was to begin the development of a modern industrial strategy that will help businesses to create high-quality, well paid jobs right across the country.

“This is a new long-term approach to shaping a stronger and fairer economy for decades to come.

“It helps young people to develop the skills they need to take up the high-paid, high-skilled jobs of the future.

“Our Industrial Strategy will propel Britain to global leadership of the industries of the future, seizing the big opportunities of our time – from Artificial Intelligence and Big Data to clean energy and self-driving vehicles.”

This investment will see public R&D spending increase as a share of GDP for each of the next five years and bring investment to levels last seen in the 1980s. It builds on the commitment made last year to raise R&D spending from £9bn in 2015/16 to £12bn in 2020/21.

Next Monday the launch of the Industrial Strategy White Paper will announce four Grand Challenges that reflect global trends that will shape our future and industries where the UK has an edge, these are artificial intelligence and the data economy; clean growth; healthy ageing; and the future of mobility.

The government will work with business, academia and civil society to build on UK strengths in these areas and ensure Britain’s economy is fit for the future. The Business Secretary will set out more detail on these Grand Challenges next week.

The Business Secretary, Greg Clark said:

“Through our Industrial Strategy we are committed to building a knowledge and innovation-led economy and this increase in R&D investment, to 2.4 per cent of GDP, is a landmark moment for the country.

“The UK is a world leader in science and innovation. By delivering this significant increase as part of our Industrial Strategy, we are building on our strengths and working with business to ensure that UK scientists and researchers continue to push the boundaries of innovation.

“We want the UK to attract, and create, the best and brightest talents, from Nobel Prize winners to ambitious graduate students, and this game-changing investment will ensure we are the home of the industries of the future and high-quality, good jobs.”

The Transforming Cities Fund will address weaknesses in city transport systems in order to raise productivity and spread prosperity. It will fund new local transport links, making it easier to travel between often more prosperous city centres and frequently struggling suburbs.

This will help make sure people across the country have better options to combine different modes of transport – supporting projects which will improve connectivity, reduce congestion and introduce new mobility services and technology.

The Secretary of State for Transport, Chris Grayling said:

“Investment in transport is crucial to a strong and resilient economy. The Transforming Cities Fund will drive productivity and growth in cities where this is most needed, connecting communities and making it quicker and easier for people to get around.

“We have already seen the impact of better integrated transport links for both passengers and the local economy in cities like Nottingham and Manchester. This new fund will enable more English cities to reap these benefits, helping to deliver the opportunities and ambition of the Industrial Strategy across the country, as well as driving forward the Northern Powerhouse and Midlands Engine.”

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