Europe – Human medicines: highlights of 2023
The Agency recommended two vaccines to protect against lower respiratory tract disease caused by respiratory syncytial virus (RSV), and the first advanced therapy medicinal product using...
Switzerland – Swissmedic updates guidances on API, fast-track pathway, and more
Swissmedic has made updates to several of guidances related to active pharmaceutical ingredients (API), temporary authorization, products that receive fast-track authorization, and other documents...
UK – Pfizer’s COVID-19 antiviral Paxlovid recommended by NICE for expanded use
A further 1.4 million people with an increased risk for progression to severe COVID-19 will be eligible for Paxlovid following a positive test.
NICE already recommends the...
Europe – Potential risk of neurodevelopmental disorders in children born to men treated with...
EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines. These measures are to address a potential...
Europe – EMA explains how tweaked Brexit deal will affect medicinal products
The European Medicines Agency (EMA) has answered nine questions on how the revised Brexit rules apply to centrally authorized medicinal products for human use...
UK – AstraZeneca/Merck’s Lynparza recommended by NICE for advanced prostate cancer
The PARP inhibitor has been specifically recommended for NHS use alongside anti-androgen therapy Zytiga (abiraterone) and prednisone or prednisolone in adults with untreated hormone-relapsed...
Europe – EU agencies adopt workplan on AI in medicines regulation
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have adopted a workplan to facilitate the “responsible and beneficial” use of...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Seven new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2023 meeting.
The committee recommended granting a conditional...
Europe – First version of the Union list of critical medicines agreed to help...
The list is an important tool to support the EU’s efforts in ensuring supply security and preventing shortages of critical medicines. Inclusion in the...
Europe – Global regulators strengthen efforts to ensure continuous availability of safe and high-quality...
On 20 July 2023, a virtual workshop was held to discuss progress made in the development of a PQ KMS. The workshop was jointly organised by...
