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...
UK – AstraZeneca/Merck’s Lynparza combination recommended by NICE for advanced ovarian cancer
The drug has been specifically recommended for NHS use alongside Genentech’s Avastin (bevacizumab) as a maintenance treatment in adults with advanced epithelial ovarian, fallopian...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023
PRAC recommends measures to minimise the risk of serious side effects with medicines containing pseudoephedrine
EMA’s safety committee, PRAC, has recommended new measures for medicines containing...
UK – Pfizer’s RSV vaccine granted MHRA approval to protect infants and older adults
RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can...
UK – MHRA instructs health organisations to prepare now for new measures to reduce...
Healthcare organisations are being instructed by the Medicines and Healthcare products Regulatory Agency (MHRA) now to put in place a plan to implement the first phase...
