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”
Category: Regulation
Regulatory news and updates
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”
MDCG issues guidance on legacy device certification issues surrounding the new MDR
There has been growing concern among many manufacturers about how the new Medical Device Regulation (MDR) will affect currently marketed devices, also known as “legacy devices”. Read more “MDCG issues guidance on legacy device certification issues surrounding the new MDR”
Biosimilar medicines: is further regulatory convergence required?
A biosimilar is a biological medicine which is highly similar, in terms of structure, activity, efficacy and safety, to another biological medicine (reference medicine) which is already approved by a regulatory authority. Read more “Biosimilar medicines: is further regulatory convergence required?”
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 is a Two-year Delay to the Implementation of EUDAMED a Positive Opportunity for the Medical Device Industry?
The European Commission (EC) has announced a two-year delay to the implementation of it’s new EUDAMED database under the incoming Medical Device Regulation (MDR). Read more “How is a Two-year Delay to the Implementation of EUDAMED a Positive Opportunity for the Medical Device Industry?”
The pharmaceutical industry must adjust its development and regulation models to unlock the true potential of gene therapy
Over the past few years, the promise of curative gene therapies for rare disease has started to become a reality. Read more “The pharmaceutical industry must adjust its development and regulation models to unlock the true potential of gene therapy”
The Indian government will introduce a single regulatory framework for all medical devices
Between 2009 and 2015, India’s medical device industry grew by almost $2billlion. Read more “The Indian government will introduce a single regulatory framework for all medical devices”
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”