Europe – Guidance : Anonymisation of personal data and assessment of commercially confidential information...
This document gives general guidance to applicants/marketing authorisation holders (MAHs) on the retention/removal of personal data (PD) and identification of commercially confidential information (CCI)...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Eight new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting.
The CHMP recommended granting a marketing authorisation for Altuvoct* (efanesoctocog alfa), for...
UK – 170,000 people in England to have further treatment choice for preventing migraine...
Also called Aquipta and made by AbbVie, NICE has recommended atogepant as an option for preventing chronic and episodic migraines in adults who have had at least...
UK – Children and teenagers with an aggressive form of brain cancer set to...
A new targeted drug combination treatment, described as a ‘step-change in care’ for children and young people with an aggressive form of brain cancer,...
Europe – EMA seeks feedback on quality, therapeutic equivalence of inhaled drugs
The European Medicines Agency (EMA) has released two draft guidelines for consultation on inhaled medicines. One covers the pharmaceutical quality of inhalation and nasal...
Europe – New recommendations to strengthen supply chains of critical medicines
These recommendations have been developed by EMA’s Medicines Shortages Steering Group (MSSG) and will facilitate the availability and supply of critical human medicines for which vulnerabilities...
Europe – Parliament adopts its position on EU pharmaceutical reform
The legislative package, covering medicinal products for human use, consists of a new directive (adopted with 495 votes in favour, 57 against and 45...
Europe – Reflection papers on regulatory requirements for the development of medicinal products for...
The drafting of a reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) is intended in order to...
Europe – European Commission proposes updates to medical device phthalates guidelines
The European Commission has launched a public consultation on an update to its guidelines on benefit-risk assessments for medical devices containing phthalates. This is...
Europe – EU recommendations for 2024/2025 seasonal flu vaccine composition
EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn...
