Medicines regulation and law

European regulator’s committee recommends new safety measures for medicines containing pseudoephedrine

The European Medicines Agency's risk assessment committee has recommended that medicines containing pseudoephedrine should not be used in patients with severe or uncontrolled high blood pressure, or people with severe acute or chronic kidney disease or failure.…

New valproate prescriptions must be signed off by two specialist doctors from January 2024, says MHRA

The requirement for valproate prescriptions, which will come into effect on 31 January 2024, was first announced in December 2022.…

MHRA seizes £5m of illegally-traded medicines in 15th year of medicines crime initiative

Interpol says the haul from this year's Operation Pangea posed a “significant threat to consumer safety”.…

Safety measures introduced for isotretinoin prescribing in patients aged under 18 years

Recommendations to improve the safety of prescribing the acne drug isotretinoin have been made by the Commission on Human Medicines.…

UK regulator seizes 369 potentially fake weight loss pens following reports of hospitalisations

The Medicines and Healthcare products Regulatory Agency said the public should consult a healthcare professional qualified to provide semaglutide and liraglutide via prescription.…

UK regulator to consider EMA recommendation to avoid topiramate in pregnancy

Exclusive: The UK medicines regulator said it would carefully consider recommendations made by the European Medicines Agency, which were published following a review of data showing an increased risk of developmental disorders among children exposed to topiramate before birth.…

Number of fitness-to-practise cases open for more than a year increases to 430 cases, regulator tells MP

The number of cases open for more than three years rose to 77 cases in 2022/2023, up from 49 cases in 2021/2022.…

Pharmacists can do more to bridge the safety gaps for people with learning disabilities

People with learning disabilities are more likely to be taking multiple medicines, but labels are not designed with them in mind — it is time to pay more attention to this patient group’s needs.…

PSA writes to health secretary to ‘raise concerns’ over GPhC’s fitness-to-practise timeliness

Duncan Rudkin, chief executive of the GPhC, said it was “an absolute priority” for it to resolve fitness-to-practise cases “in a timely way”.…

Hydrocortisone manufacturers to be fined almost £130m after tribunal upholds ruling

The Competition and Markets Authority said NHS spending on hydrocortisone tablets rose from £0.5m per year to over £80m.…