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Regulatory
UK regulator tightens pharmacy rules for weight-loss jabs
Britain’s pharmacy regulator has adopted more stringent prescription measures to prevent medicines from being supplied “inappropriately”, meaning people will no longer be able to...
Japan approves mpox drug that failed two efficacy trials
Approval granted earlier this month by Japan’s regulatory agency for the antiviral drug tecovirimat – also known as TPOXX – for the treatment of...
US bans Red No 3 dye, flags cancer links
The US has banned the use of a synthetic red food dye that gives some sweets, cakes and certain oral medications a cherry-red colour,...
FDA adds Guillain-Barre alert for RSV jabs
The US Food & Drug Administration (FDA) has issued a safety alert linking possible Guillain-Barré syndrome (GBS) with two respiratory syncytial virus (RSV) vaccines...
Marketers of CBD-coated tampons warned by FDA
The US Food & Drug Administration (FDA) has slammed a UK company for “adulterating” its products, sending it a warning letter for selling tampons...
US medical school in hot water for liquefying bodies after using for training
The University of North Texas Health Science Centre has been ordered to immediately stop its practice of liquefying bodies after using them for training...
FDA plans decongestant ingredient removal
Nearly two decades after an initial expert recommendation, the US Food and Drug Administration has proposed starting the process of removing a common ingredient...
Registration practice rules for sangomas from 2025
When they need healthcare, writes Sipokazi Fokazi for Bhekisisa, about 70% of South Africans, mostly in rural areas, visit sangomas first before they go to...
Regulatory challenges with rapid rise of AI technology
Medical device technology is now deeply entrenched in many patients’ healthcare and can have an extraordinary impact on their lives, with artificial intelligence (AI)...
EMA withdraws authorisation for Duchenne MD treatment drug
After re-examining available data, the European Medicine Agency’s human medicines committee (CHMP) has confirmed its previous recommendation to not renew the conditional marketing authorisation...
NHS dumps hip implant after fractures increase
A metal hip implant used in thousands of NHS patients will be axed because of an increase in bone fractures, according to the Medicines...
Lilly signs deal for RA drug production in Africa
Egypt’s Eva Pharma has inked a licensing deal with Eli Lilly to manufacture the latter’s rheumatoid arthritis treatment Olumiant and eventually supply the drug in 49...
SAHPRA clarifies B-BBEE policy
The South African Health Products Regulatory Authority (SAHPRA) has rejected what it calls a misinformation campaign related to its draft B-BBEE Policy, which it...
SAHPRA policy seeks B-BBEE compliance for healthcare licence approvals
Some stakeholders fear that a revised policy proposed by the SA Health Products Regulatory Authority (SAHPRA), making it mandatory for applicants to submit broad-based...
FDA bans harmful beverage additive
The US Food and Drug Administration (FDA) has banned the use of brominated vegetable oil (BVO) in food products as from 2 August, but...
Small hospital groups get further competition rules reprieve
Smaller private hospital groups have been granted another five-year exemption from certain competition regulations by the Department of Trade, Industry & Competition (DTIC) in...
UK flags risks of epilepsy drug during pregnancy
After a major safety review triggered by a recent study in Europe, Britain’s Medicines and Healthcare Products Regulatory Agency (MRHA) has prohibited the dispensing of migraine...
Council bans vape sales in pharmacies
Pharmacies are banned from selling vapes as aids to quit smoking, the SA Pharmacy Council registrar Vincent Tlale said, with the products now added...
Experts, FDA flag synthetic chemicals in new vapes
Independent researchers as well as the FDA have sounded the alarm over nicotine alternatives used in vapes being launched in the US and abroad,...
FDA says no to ecstasy for PTSD treatment
US Food and Drug Administration advisers have voted against a therapy based on the mind-altering drug MDMA, known as “ecstasy”, for patients with post-traumatic...
UK safety updates for topical steroids
British health authorities have issued a drug safety update saying that while topical steroid products are safe and highly effective treatments for managing various...
Surrogacy group fails in bid to declare regulations unconstitutional
A bid to declare regulations under the National Health Act relating to the control over artificial fertilisation, embryo transfer, storage and destroying of zygotes...
Justice yet to be served in US osteoporosis drug case
A US court case by 1 000 plaintiffs against pharmaceutical company Merck has been dragging on since 2011, writes Gregory Curfman in JAMA Network,...
New SAHPRA guidelines planned to address codeine abuse
South Africa’s medicines regulator is developing a new set of initiatives to stem the misuse of codeine, found in certain pain relief medicines and...
Asthma drug warning stepped up after 500 children react
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) says more prominent warnings would be added to the information provided on boxes of the asthma...
FDA accelerated approval for Duchenne drug questioned
The decision by the US Food and Drug Administration to grant accelerated approval for gene therapy to treat Duchenne muscular dystrophy, and which includes...
Clicks pharmacy dispute resolution imminent
The resolution of the restructure of the Clicks private-label medicine business with the Department of Health is imminent, the company has suggested, with analysts...
FDA approves new UTI treatment
The US Food and Drug Administration has approved Pivya (pivmecillinam) tablets for to treat uncomplicated urinary tract infections (UTIs), caused by susceptible isolates of...
UK issues side effect alert for men on hair loss, prostate drug
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) will introduce a patient alert card to boost awareness among men taking finasteride, warning about potential...
NICE approves drug combo for young brain cancer patients
British children and teenagers with an aggressive form of brain cancer may benefit after a new life-extending drug combination was recommended for NHS use...
One-year reprieve for low-cost health insurers
An 11th hour reprieve has been granted by the Council for Medical Schemes (CMS) to insurers offering cheap primary healthcare cover, giving them another...
FDA flags heart pump linked to 49 deaths
The US Food and Drug Administration (FDA) has issued its highest-level alert about a heart pump that has been linked to 49 deaths and...
Another delay for Alzheimer’s drug as FDA sets up review panel
The FDA has delayed its decision on Eli Lilly’s highly anticipated Alzheimer’s drug donanemab and plans to convene an advisory committee to review it...
UK review calls for action on ‘biased’ medical devices
British experts have joined what’s growing into a global call for action on medical devices that are prone to unfair biases, including blood oxygen...
Asthma drug sanctioned for serious food allergies
Food allergies for products like milk, eggs, walnuts and peanuts could be more easily tolerated with a drug newly approved by the US Food...
FDA approves first cell therapy for metastatic melanoma
The US Food and Drug Administration (FDA) has approved lifileucel (Amtagvi, Iovance Biotherapeutics) for the treatment of certain adults with unresectable or metastatic melanoma, marking the first approval...
Label updates for anti-nausea jab products – FDA
The US Food & Drug Administration (FDA) has issued an alert regarding labelling updates intended to further reduce the risk of severe chemical irritation...
New UK rules for treatment with acne drug
Britain’s health watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA), has announced a series of regulatory changes to strengthen the safe use of...
New rights for UK donor babies as they turn 18
Around 30 young British adults – conceived via sperm or egg donation in the UK in 2005 – will soon be able to discover the...
NHLS refuses to share science data over Popia concerns
Researchers are at loggerheads with the National Health Laboratory Services for the latter’s interpretation of the Protection of Personal Information Act (Popia) and refusal...