UK – Guidance published on the new international regulatory recognition routes for medicines approvals
Following announcement in May of the new scheme to replace the current EC Decision Reliance Procedure (ECDRP) on 1 January 2024, this guidance informs the sector on how...
UK – NICE recommends Chiesi’s Elfabrio for adults with Fabry disease
The NICE committee concluded that the treatment would be an additional ERT for patients with and without an amenable mutation and was a relevant...
USA – FDA publishes additional guidances on delay of enforcing DSCSA electronic tracking requirements
The US Food and Drug Administration (FDA) published two additional guidances with immediate effect that provide more details for trading partners on the one-year...
Europe – PRAC recommends new measures to avoid topiramate exposure in pregnancy
Further restrictions on use; pregnancy prevention programme to be put in place
EMA’s safety committee (PRAC) recommends new measures to avoid exposure of children to...
Europe – COVID-19: Commission authorises adapted COVID-19 vaccine for Member States’ autumn vaccination campaigns
The Commission has authorised the Comirnaty XBB.1.5-adapted COVID-19 vaccine, developed by BioNTech-Pfizer. This vaccine marks another important milestone in the fight against the disease....
Europe – Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant.
The vaccine – known as Comirnaty Omicron XBB.1.5...
UK – NHS world first rollout of cancer jab that cuts treatment time by...
Following the green light from the Medicines and Healthcare products Regulatory Agency (MHRA), the NHS in England will be the first health system in...
UK – Nitrosamines impurities in medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines and...
UK – NICE recommends Amryt’s Filsuvez for rare skin disorder
Around 670 people in England with epidermolysis bullosa will benefit from the treatment
The National Institute for Health and Care Excellence (NICE) has recommended Amryt...
UK – NICE gives green light for MSD’s Keytruda
The decision is the first verdict based on data from a wider immunotherapy ‘basket’ study
MSD has revealed that the National Institute for Health and...
