The recent authorisation of an innovative therapy highlights the key players in gaining accelerated approvals

An article published in Clinical Pharmacology & Therapeutics by the European Medicines Agency (EMA), describes the interactions needed between stakeholders to accelerate patient access to ground-breaking new therapies. Read more “The recent authorisation of an innovative therapy highlights the key players in gaining accelerated approvals”

ICH survey shows greater regulatory harmonisation among pharmaceutical companies and regulators

The results of a recent survey released by the International Council on Harmonisation (ICH) suggest that pharmaceutical companies and regulators around the world are adopting and adhering to its guidelines on quality, safety and efficacy in drug development. Read more “ICH survey shows greater regulatory harmonisation among pharmaceutical companies and regulators”

The latest advancements on the use of artificial intelligence in drug development

Approximately 50% of late-stage clinical trials fail due to ineffective drug targets, meaning only 15% of drugs advance from Phase II trials to approval. Artificial intelligence (AI) can help to enhance drug development by making more accurate predictions in novel areas of biology and chemistry. Read more “The latest advancements on the use of artificial intelligence in drug development”

Did you know that certain Class I devices could get four extra years to comply with EU MDR?

A decision is soon expected on a corrigendum initiated in May by the European Commission (EC), to extend the existing transition period for certain class I reusable devices, including some software, that are being up-classified. Read more “Did you know that certain Class I devices could get four extra years to comply with EU MDR?”

How can novel, non-randomised analytic methods be validated for regulators? The EMA discusses

Real-world evidence (RWE) such as electronic health records (eHRs) can be combined with patient-level data from completed randomised controlled trials (RCTs) and new data sources such as social platforms, to potentially understand more about drugs’ benefits and risks. Read more “How can novel, non-randomised analytic methods be validated for regulators? The EMA discusses”