Europe – Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for...
The assessment report of the CHMP’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products provides general guidance...
Europe – Clinical Trials Information System (CTIS) – Sponsor Handbook
The aim of the EMA CTIS Sponsor Handbook (‘Handbook’) is to provide clinical trial (CT) sponsors representing pharmaceutical industry, SME (small and medium-sized enterprises),...
Australia – Nitrosamine risk assessment in Category 1 prescription medicine registration applications
Sponsors need to be aware of the global issue relating to nitrosamine impurities in medicines. In particular, they should be familiar with the known...
International – ICH paper calls for ‘stepwise’ harmonization of RWE
The International Council for Harmonisation (ICH) issued a Reflection Paper outlining a “stepwise” approach to harmonization of real-world data and evidence (RWD/RWE) that includes...
Europe – Phasing out of extraordinary COVID-19 regulatory flexibilities
EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19...
Europe – Global regulators confirm good safety profile of COVID-19 vaccines
EMA has just endorsed a joint statement on the safety of COVID-19 vaccines issued by the International Coalition of Medicines Regulatory Authorities (ICMRA).
Evidence from more than 13...
UK – BMS’ Sotyktu gets NICE green light for NHS use
The therapy becomes an option for moderate-to-severe plaque psoriasis in certain adults
Bristol Myers Squibb (BMS) has announced that the National Institute for Health and...
France – Clomid (citrate de clomifène) : le traitement doit être arrêté en cas...
Clomid, un médicament à base de citrate de clomifène, permet de stimuler l’ovulation. Il est prescrit en première intention pour traiter certaines stérilités, induire...
Europe – Guideline on clinical investigation of medicinal products in the treatment or prevention...
This guideline intends to address the current EU regulatory position on the main topics of the clinical development of new medicinal products in the...
USA – FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes
Today, the U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for...
