Europe – EMA revises Q&A guidance on drug-device combination products

The European Medicines Agency and the Co-ordination Group for Mutual Recognition and Decentralized Procedures (CMDh) have issued a revised guidance that clarifies the information...

Europe – EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine...

Update as of 21 May 2024 The European Commission has asked the CHMP to review its January opinion on the renewal of the marketing authorisation for Translarna. The CHMP will now consider the...

Europe – Hydroxyprogesterone caproate medicines to be suspended from the EU market

EMA’s safety committee, PRAC, has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union (EU). A review by the PRAC concluded...
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) on March 11th, 2020

Europe – EU report examines barriers to combined studies of drugs, IVDs, and devices

A lack of alignment between the Clinical Trials Regulation (CTR) the In Vitro Diagnostic Medical Device Regulation (IVDR), and the Medical Device Regulations (MDR)...
Advice for Management of Clinical trials in relation to Coronavirus

UK – New cabotegravir formulations approved to help prevent HIV-1 infection in adults and...

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (3 May 2024) approved two new formulations of the medicine cabotegravir (Apretude 30 mg...

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...

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