HomeRegulatory
Regulatory
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...
FDA approves first natalizumab biosimilar for MS
There’s new hope for some people who suffer relapsing forms of multiple sclerosis (MS) — the chronic, inflammatory disease of the nervous system thought to...
FDA approves RSV jab for use in pregnant women
The US Food and Drug Administration has approved Pfizer’s respiratory syncytial virus (RSV) vaccine for use in women during the middle of the third...
FDA panel green-lights RSV pregnancy jab, but concerns persist
Despite some concerns, a US Food and Drug Administration (FDA) advisory panel has approved a Pfizer vaccine to be given to pregnant women that...
FDA preliminary nod for muscular dystrophy gene therapy
Despite some reservations, US Food and Drug Administration advisers have recommended the agency approve the first gene therapy for Duchenne muscular dystrophy, the most...
Health warnings on alcohol bottles for Ireland
In line with requirements for food packaging, Ireland plans to introduce health warning labels on alcohol products, listing risks as well as a product’s...
Muscle bulking supplement warning from FDA
The US Food and Drug Administration (FDA) says it continues to receive adverse event reports linked to selective androgen receptor modulators – or supplements...
Australia lifts Ivermectin restrictions
Prescribing oral Ivermectin for “off-label use” will no longer be limited to specialists like dermatologist, gastroenterologists and infections disease experts, says Australia’s Therapeutic Goods...
Nasal decongestant safety review due to rare brain risk
Experts are assessing a rare but potentially serious brain side effect of nasal decongestants containing pseudoephedrine, saying they might cause vessels supplying the brain...
New rules published for pharmacy fees
The South African Pharmacy Council has, in a Government Gazette notice, published rules relating to the services for which a pharmacist may levy a...
Pfizer booster stroke risk for seniors unlikely, says CDC
The risk of stroke for seniors from the Pfizer Omicron booster is “very unlikely”, the US Centres for Disease Control and Prevention (CDC) has...
Concern over FDA's fast-track approval of Alzheimer's drugs
The US Food and Drug Administration (FDA) has approved a highly anticipated new drug – Leqembi, also known as lecanemab – designed to slow cognitive...
UK approves one-shot RSV vaccine for babies
Britain’s regulator has given the go-ahead to a new single-shot vaccine that protects babies against the common and potentially dangerous winter virus known as...
SAHPRA authorises COVID home tests
South Africa’s medicines regulator has finally authorised COVID-19 home-test kits, after repeated calls for this for more than a year, now allowing people to...
Massive Philips recall highlights flaws in medical device surveillance
In the wake of several recalls of medical devices, including one of the largest in history in June last year by Philips Respironics (Philips),...
EU regulator blocks merger of US firms in cancer-screening sector
In a rare move by European regulators against two US companies, the European Union’s anti-trust watchdog has blocked the buyout of cancer-screening company GRAIL...
Australia put the brakes on cosmetic surgery ‘cowboys’
In the biggest crackdown on Australia’s $1.4bn cosmetic surgery industry, Health Minister Mark Butler and his state counterparts have agreed to sweeping changes focusing...
FDA approves over-the-counter hearing aids for Americans
The US Food and Drug Administration (FDA) has given the green light to over-the-counter (OTC) hearing aids, which will not only lower costs but...
UK MPs urge regulation of body image surgeries
UK MPs have urged the government to escalate the introduction of a promised licensing regime for non-surgical cosmetic procedures to prevent vulnerable people from...
Zimbabwe gives the nod to sales of medical cannabis
Debt-ridden Zimbabwe, one of the first African countries to legalise cannabis in 2018, has finally given the go-ahead for cannabis-based medical products to be...
Beginning of the end for SAMA as Western Cape branch suspended?
The South African Medical Association (SAMA) board has suspended its Western Cape branch amid charges and counter charges of suspicious and irregular conduct, with...
SA’s health regulations update continues
The Department of Health is continuing with controversial plans to update the regulations for managing notifiable diseases, despite the draft regulations in the National...
New fee regulations released by Pharmacy Council
Pharmacists must ensure that, when a service for which they wish to levy a fee involving the supply of medicine, the patient is furnished...
Pharmacy Council publishes Competency Standards for support personnel
The SA Pharmacy Council is committed to its mandate of ensuring that pharmacists and pharmacy support personnel have the necessary knowledge and skills to...
Medical aids seek Competition Act exemption on sharing prices, costs
In a notice in the Government Gazette, the Competition Commission has announced that the Board of Healthcare Funders of Southern Africa has applied for...
Competition Commission grants exemptions to day hospitals
The Competition Commission has, by notice in the Government Gazette, announced that it has granted the Day Hospital Association a conditional exemption from certain...
DoH extends time for comment on new Covid health regulations
Health Minister Dr Joe Phaahla has extended the period for comment on new health regulations to 5 July, according to a Health Department statement....
UCT call on SAHPRA to revisit single-use medical device ruling
A group of medical professionals from the University of Cape Town (UCT) has appealed to the South African Health Products Regulatory Authority (SAHPRA) to...