France – Forfait innovation : une 1ère technologie de santé inscrite au remboursement par...
Mis en place en 2009 et piloté par le ministère chargé de la santé, le forfait innovation est un dispositif dérogatoire et temporaire de...
New Zealand – Guidelines on the Regulation of Therapeutic Products in New Zealand
Medsafe requires evidence of compliance with Good Manufacturing Practice (GMP) for sites
used to manufacture and pack medicines. This evidence is required for medicines in...
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)...
International – ICH to adopt final guideline on drug interaction studies early next year
The pharmaceutical industry would like to get more clarity on the timing of drug-drug interaction (DDI) studies and the scope of these DDI studies...
UK – NICE publishes draft guidance recommending three COVID-19 treatments
The treatments recommended by NICE are Roche’s RoActemra (tocilizumab) and Eli Lilly’s Olumiant (baricitinib), both indicated for use in a hospitalised setting in patients...
USA – FDA finalizes multiple endpoints guidance
The US Food and Drug Administration’s (FDA) on Thursday finalized guidance to sponsors on managing multiple endpoints in clinical trials to minimize the likelihood...
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...
International – WHO issues guidance on nitrosamine controls in drug manufacturing
The World Health Organization (WHO) released draft guidance for comment this month on good manufacturing practices (GMP) for the prevention and control of contamination...
Europe – Addendum to the guideline on the evaluation of medicinal products indicated for...
This addendum to the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 3) has been developed to...
UK – Ipsen’s cabozantinib receives NICE approval for advanced hepatocellular carcinoma
Specifically, the recommendation is for adult patients who have had sorafenib – the standard initial treatment for advanced disease – only if they have...
