Medicines regulation and law

MHRA approvals miss targets by more than 100 days, data show

In January 2024, it took an average of 333 days for a regulatory decision to be made for a medicine under the national route for marketing authorisations, versus a statutory timescale of 210 days.…

Pharmacy2U purchase of LloydsDirect given go ahead by competition regulator

The Competition and Markets Authority announced it was investigating the acquisition in December 2023.…

UK regulator recommends new safety measures for medicines containing pseudoephedrine

Safety information for all medicines containing pseudoephedrine will be updated to make clear the risk of rare, but serious, side effects.…

Codeine linctus to be reclassified as a prescription-only medicine

While codeine linctus is effective for long-term dry cough, the Medicines and Healthcare products Regulatory Agency said “misuse and abuse can have major health consequences”.…

More than £30m of illegal medicines seized by MHRA in 2023

The Medicines and Healthcare products Regulatory Agency says its support to online marketplaces led to the removal of more than half a million unregulated medicines and medical devices before they hit the UK market.…

NHS England recommends generic apixaban over edoxaban for treatment of atrial fibrillation

For patients already taking a direct-acting oral anticoagulant for atrial fibrillation, NHS England advised commissioners to “consider developing local policy to review patients’ current treatment”.…

Pharmacy technicians could supply naloxone without prescription under government proposals

The government has expanded on a previous consultation proposing to enable pharmacists to supply naloxone without a prescription.…

Pharmacy regulator consults on draft standards for chief pharmacists

By producing new standards, the General Pharmaceutical Council says its aim is to clarify chief pharmacists’ roles and responsibilities to improve pharmacy governance.…

EMA committee recommends suspension of almost 400 medicines owing to flawed studies

The European Medicines Agency said irregularities in study data and other inadequacies had “raised serious concerns about the validity and reliability of data” from studies conducted at Synapse Labs.…

Non-hormonal treatment for menopause vasomotor symptoms approved for use in the UK

Fezolinetant is an alternative to hormone replacement therapy for people experiencing vasomotor symptoms of menopause.…