The Medicines and Healthcare products Regulatory Agency (MHRA) has appointed Dekra to certify medical devices in the UK.
Dekra Certification UK has joined the three current UK approved bodies, increasing the UK's capacity to process conformity assessments for medical devices to ensure
safe and effective devices reach the UK public.
An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in
the UK Medical Devices Regulations 2002.
Following an appropriate assessment, the new approved body will issue relevant certification allowing manufacturers to place a UKCA marking on their products before
putting them on the market.
Dr Laura Squire, chief healthcare quality and access officer at the MHRA, said: "This is a major milestone in our mission to ensure patients across the UK have access
to the high-quality medical devices they need to protect their health.
Colonis, a subsidiary company of the Clinigen Group has received the Medicines and Healthcare products Regulatory Agency (MHRA) approval for Melatonin 1mg/ml
Oral Solution for sleep onset insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD).
Clinical evidence demonstrates that Melatonin has the potential to decrease sleep latency and increase sleep efficiency in children with ADHD and chronic sleep onset
insomnia.
Children with ADHD are statistically more likely to have sleep onset insomnia than non-ADHD children. The prevalence of sleep onset insomnia in children with ADHD
ranges from 25%-50%. Sleep onset insomnia in children with ADHD can affect their mood, attention, behaviour and school performance.
Henno Welgemoed, Director of Medical Affairs at Colonis said: "We welcome the MHRA's approval for a condition that negatively affects the quality of life for
children and adolescents diagnosed with ADHD and increases the burden for support networks."
The Pharmaceutical Services Negotiating Committee (PSNC) has urged the pharmacy contractors to follow appropriate procedures for unplanned temporary closures
due to current workforce pressure, to avoid a breach of terms of service.
"If the temporary closure is not for reasons beyond the contractor's control, this may be a breach of the terms of service," said PSNC.
The committee also informed that in some areas, NHS England regional teams may ask contractors to complete a new notification form for any temporary closures that
request more information than the standard form, for example, on the mitigating actions taken by the contractor.
It added: "Completion of these forms is voluntary but may help to show NHS England that the closure was for reasons beyond the contractor's control, or that the
overall circumstances of the closure, including time closed and steps taken to ensure patient and public needs are met, indicate that there is no public interest
in taking any regulatory/performance action (such as a breach notice) against the contractor."
The Pharmaceutical Society NI (PSNI) has announced that Michaela McAleer will be replacing Trevor Patterson as Chief Executive of PSNI.
After 15 years at the helm, Patterson announced his intention to retire. Jonathan Patton, Vice President of the Society said, "Joining the Society from the
construction sector Trevor brought fresh thinking and vigour to the Society and quickly established his credibility with pharmacists, Council, stakeholders and
fellow regulatory bodies."
"Trevor has presided over tremendous change and development through his tenure with equal measures of professionalism and passion on creating safer protections
for the public and ensuring pharmacists achieved world class standards in their profession. We are saddened to see him depart but on behalf of Council I wish him a
long and healthy retirement and wish him well in the next chapter of life. We are indebted to him for his dedication to the Pharmaceutical Society NI."
"Losing the constant and continuity of our 15 year serving Chief Executive ushers in a time of change and evolution for us as the Pharmacy Regulator. We are in the
midst of a fast moving and changing environment as we implement continuous improvement.
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during
anaphylaxis.
On the start of World Allergy Week (19 June), an annual initiative led by the World Allergy Organization, aiming to raise awareness of allergies, their management
and prevention, the MHRA has collaborated with allergy awareness advocates to share an easy step-by-step infographic guide and video outlining the latest advice
from the CHM's working group on the safe and effective use of AAIs.
Steve Barclay, Secretary of State for Health and Social Care said: "A severe allergic reaction can be life-threatening. One in five people in the UK suffer with at
least one allergy, so it's vital people are equipped with the knowledge to keep themselves safe.
Adrenaline auto-injectors - also known as AAIs or by their brand names such as EpiPen - are highly effective and convenient for the immediate treatment of
anaphylaxis. If you have been prescribed one, please carry it with you at all times and make sure you are up to date on the latest safety guidance - it could
save your life."
The Medicines and Healthcare products Regulatory Agency (MHRA) has maintained the prescription-only status of Aquiette 2.5mg Tablets for symptoms of
overactive bladder, following a public consultation and the review of a reclassification application from the manufacturer Maxwellia Ltd.
Aquiette, which contains the active ingredient oxybutynin, is used for the treatment of long-term symptoms of overactive bladder (OAB) in women aged between 18
and 65, such as the urgent need to urinate and frequent urination without pain.
The regulator decided against the reclassification of Aquiette 2.5mg Tablets from a prescription-only medicine (POM) to a pharmacy (P) medicine, concluding that
a medical prescription continues to be required to ensure the safe use of Aquiette.
Since an OAB diagnosis requires medical supervision to ensure that the correct treatment is received, and other health conditions are not overlooked or left untreated,
the MHRA said the decision would ensure that the medication is used safely and appropriately under medical supervision.
"After taking on board the views of the many patients and healthcare professionals who responded, we have decided to refuse the reclassification of Aquiette 2.5mg
Tablets for women with symptoms of overactive bladder (OAB)," Dr Laura Squire, MHRA chief healthcare quality and access officer, said.
British health agencies have secured funding to develop a standardised approach to test the performance of vaccines being used or in development against
monkeypox, days after the World Health Organization labelled the growing outbreak a global health emergency.
The Coalition for Epidemic Preparedness Innovations (CEPI) said it would give up to $375,000 to the Medicines and Healthcare products Regulatory Agency (MHRA) and
Health Security Agency (UKHSA) to develop standard tools to assess the strength and duration of immune responses generated by current vaccines, and for tests used
to detect monkeypox antibody levels.
Apart from administration fees, these tools will be made freely available to the global scientific community, paving the way for a common standardised assessment
between countries documenting vaccine performance against monkeypox, CEPI said.
Until this year, the viral disease has rarely spread outside Africa where it is endemic. But reports of a handful of cases in Britain in early May signalled that
the outbreak had moved into Europe. So far, there have been more than 16,000 confirmed cases of monkeypox in more than 75 countries.
The General Pharmaceutical Council (GPhC) has committed to playing its part in addressing climate change by undertaking work to establish a carbon footprint
baseline to improve its environmental performance.
In a statement on Monday (July 18) the pharmacy regulator laid out what it called its vision "to have safe and effective pharmacy care at the heart of healthier
communities".
Stating that climate change creates health risks and exacerbates health inequalities, GPHC said: "We believe we all have a role to play in contributing to addressing
climate change."
It announced that it has just joined "a newly formed cross-regulatory group" formed to address issues such as "environmental sustainability".
"At the GPhC we have brought together colleagues from across the organisation to consider the environmental impact we have as an employer and as a regulator," it
declared.
HRA Pharma is celebrating the 1st anniversary of Hana, the first type of daily oral contraception available in the UK without a prescription.
The launch of Hana in 2021 followed the historic decision of the Medicines and Healthcare products Regulatory Agency (MHRA) to grant a marketing authorisation
and marked a significant step forward in the women's contraception category.
The company reports that pharmacists have embraced the reclassification and have found merit in using emergency contraception consultations as an opportunity to
educate women on their over-the-counter contraception options.
Alison Slingsby, innovations project manager at HRA Pharma, commented: "We have been delighted with Hana's reception - within weeks of launch, it quickly became
the best-selling mini-pill without prescription, with more than 95 per cent market share, and has maintained this market leading position ever since. We previously
had the experience of switching emergency contraceptive ellaOne to a P medicine, Hana is on track to match and eventually exceed the ellaOne volumes.
Authorities in Northern Ireland have seized more than 242,000 unlicensed prescription tablets purchased online and destined for addresses throughout NI.
The medicines seized include Diazepam, used for anti-anxiety treatment, Pregabalin, used for epilepsy and anxiety, steroids and Zopiclone.
Other prescription medicines recovered included Tamoxifen, often used in the treatment of breast cancer and Salbutamol inhalers, frequently used in the treatment
of asthma.
"Co-operation between law enforcement agencies and government departments has led to the seizure of over 242,000 illegal and unlicensed tablets purchased online
and destined for addresses throughout Northern Ireland," justice minister Naomi Long was reported as saying.
The minister, together with health minister Robin Swann and assistant chief constable Mark McEwan PSNI were highlighting Northern Ireland's input to the global,
Interpol co-ordinated Operation Pangea XV, which saw multiple packages of tablets intercepted and seized, with a street value of almost £250,000.
She praised the concerted efforts made by PSNI, Border Force and officials from the Department of Health Medicines Regulatory Group during a specific week of action
in June.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a second "bivalent" vaccine as a Covid-19 booster.
The updated booster vaccine made by Pfizer/BioNTech, targeting two coronavirus variants, has been approved for use in individuals aged 12 years and above.
In each dose of the booster vaccine, 'Comirnaty bivalent Original/Omicron', half of the vaccine (15 micrograms) targets the original virus strain and the other
half (15 micrograms) targets Omicron (BA.1).
Dr June Raine, MHRA chief executive said: "I am pleased to announce that we now have a second approved vaccine for the UK Autumn booster programme. The clinical
trial of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against the Omicron BA.1 variant as well as the original strain.
Bivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against Covid-19 variants. We have in place a comprehensive
safety surveillance strategy for all UK-approved Covid-19 vaccines, and this will include the updated booster we approved today."
The Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have added five more medicines that cannot
be hoarded or exported from the UK market.
The government has taken the following action to address the "critical shortage" of attention deficit hyperactivity disorder (ADHD) drugs.
In a crucial development on October 9, this strategic move aims to enable wholesalers to fulfil their legal obligation to supply these essential medicines to
patients across the UK.
The updated list of drugs incorporated "all" available strengths and pharmaceutical formulations, ensuring comprehensive coverage for patients' medical needs.
The Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have authorised community pharmacies
throughout the UK to dispense original full packs of Valproate-containing medicines upon prescription.
The necessary changes in regulations came into effect on 11 October which was strongly supported by 85 per cent of respondents concerned about risks to the
unborn baby if valproate-containing medicines are used in pregnancy.
The decision was made to ensure patients receive safety warnings and pictograms, including a patient card and the Patient Information Leaflet (PIL), contained
in the manufacturer's original full pack.
Valproate is a treatment for epilepsy and bipolar disorder but is also associated with birth defects and neurological disabilities.
Medicines and Healthcare products Regulatory Agency (MHRA) has reminded healthcare professionals that use of systemic (oral and injectable) Non-steroidal
anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, and diclofenac is contraindicated in the last trimester of pregnancy (after 28 weeks of pregnancy).
It has advised that patients who are unsure whether pain relief medicine they are taking is an anti-inflammatory (NSAID), to speak to doctor, midwife, or pharmacist.
Some non-prescription pain relief medicines may contain more than one active drug, therefore it is important to read the box or the leaflet provided with the
medicine to see if it contains an NSAID like ibuprofen.
The use of any non-prescription medicine for the management of pain during pregnancy should be for the shortest possible time at the lowest possible dose,
suggested MHRA.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Anastrozole in a new use to prevent the disease.
The off-patent drug has been used as a breast cancer treatment for many years.
Clinical trials have shown that it can reduce the incidence of breast cancer in post-menopausal women with increased risk by almost 50 per cent.
Health Minister Will Quince expressed his happiness on the approval of the drug that can help to prevent this "cruel disease".
He said: "We've already seen the positive effect Anastrozole can have in treating the disease when it has been detected in post-menopausal women and now we
can use it to stop it developing at all in some women.
A diabetes medicine, Mounjaro, has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat overweight patients.
The weight loss medication originally developed for Type 2 diabetes is now accessible to individuals aged 18 and over who are dealing with obesity and
weight-related health issues.
The active ingredient, tirzepatide, works by making the patient feel fuller and reducing food cravings.
The injection helps individuals lose 20 per cent of their body weight, and are advised to follow a reduced-calorie diet and increase physical activity
simultaneously.
Although it is not authorised to use on the NHS as yet but future approvals can be predicted.
The Criminal Enforcement Unit (CEU) of the Medicines and Healthcare products Regulatory Agency (MHRA) seized a large quantity of suspected illegally
traded medicines, including powerful prescription-only medicines, during raids conducted at two residential and two business premises across North Manchester.
Officers from the MHRA and Greater Manchester Police carried out searches across two residential addresses in Oldham and Cheetham in the early hours of
Wednesday (29 November), and arrested a man in his 20s on "suspicion of conspiracy to supply controlled drugs, breaches of the Human Medicines Regulations 2012
and money laundering."
They also seized thousands of illegal medicines from two business addresses in Bury and Miles Platting, including powerful opioid painkillers and antidepressants,
as well as unlicensed versions of erectile dysfunction drugs.
The European Commission launched an initiative to deal with the ongoing supply crisis on Tuesday (24 October).
The following announcement comes after the shortage of key antibiotics last winter identified by the European Health Emergency Preparedness and Response
Authority (HERA) and the European Medicines Agency (EMA).
The "European Voluntary Solidarity Mechanism" is a proposed short-term measure that involves a Member State's need for a given medicine to other Member States
to redistribute medicines from their available stock.
Additionally, the Commission intends to cooperate with member states to improve components of pharmaceutical reform with an aim to strengthen supply security.
They are setting up a few actions apart from the launch, a list of critical medicines to analyse the supply chain by early 2024; regulatory flexibilities;
strengthening security of supply; and availability of antibiotics and treatments for respiratory viruses by next winter.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 3 medicines recall for Sildenafil 100mg Film-coated Tablets
(Strandhaven Limited T/A Somex Pharma).
Manufacturer of drug, Strandhaven Limited T/A Somex Pharma has informed the MHRA that the pack size on some cartons of the batch state 8 tablets instead
of 4 tablets. This is an error due to cartons being mixed at the printers. All cartons with batch number ET22028 contain one blister strip of 4 tablets
regardless of whether it states 8 tablets or 4 tablets on the pack.
Only the batch number ET22028 is affected. Due to the low number of complaints received, only the packs labelled as containing 8 tablets are being recalled
at this time. The batch is comprised of 60340 packs, to date 195 packs have been found to be mislabelled.
The global company in information and data analytics, Elsevier launched a platform, PharmaPendium for drug candidates.
It is an effective tool that provides data including complete Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval packages for
drug development.
The platform is supported by the FDA, the Medical Devices Agency (PMDA) and the top 20 global pharma companies.
Olivier Barberan, Director of Translational Medicine Solutions spoke about how "improved access to highly relevant data plus predictive tools enhances regulatory
success, safeguarding the massive investments of pharma companies."
"Translation of preclinical research findings to humans in an efficient but safe way is one of the greatest challenges facing drug developers. We designed the
new PharmaPendium to solve this," he added.
