The EMA is proposing to update its two previous guidelines on COVID-19 vaccines to offer consolidated advice on the non-clinical and clinical development of new SARS-CoV-2 or related sarbecovirus vaccines.

The EU guideline on clinical investigation of medicinal products for psoriatic arthritis needs updating, including revised recommendations on the selection of the primary endpoint.

The June meeting of the European Medicines Agency's human medicines committee brought mixed fortunes for companies. 10 new products were recommended for pan-EU approval, two drugs were rejected, while the conditional approval of one drug is set to be revoked. PTC Therapeutics again faced disappointment regarding its Duchenne muscular dystrophy drug Translarna, but has vowed to fight back.

Not enough companies are complying with Pakistan’s pharmacovigilance rules, according to the drug regulator, which wants to remedy the situation after a previous attempt to do so failed.

The former head of the European Medicines Agency’s Data Analytics and Methods Task Force says sponsors should engage early with regulators to get feedback on the suitability of real-world data for a regulatory application. However, industry suggests developing a fitness-for-purpose framework with specific criteria to determine when RWD may be appropriate.

The European Commission has invested in several projects on novel real-world evidence methodologies, either via its key funding program for research and innovation or via public-private partnership initiatives.