EMA study outlines how patient registries may prove valuable in regulatory decisions

Patient registries can be heterogeneous in their quality and design, however a new study in Drug Safety co-authored by a European Medicines Agency (EMA) official outlines how patient registries may provide valuable data for regulatory decisions. Such registries may be used when randomised controlled trials are not feasible, for example with some rare diseases, or to meet post-marketing commitments. Read more “EMA study outlines how patient registries may prove valuable in regulatory decisions”

WHO outlines five-year regulatory action plan

In an effort to increase access to quality medical products around the world, the World Health Organisation (WHO) have created a five-year plan (2019–2023) to promote regulatory collaboration and reliance and to help National regulatory authorities (NRAs) solve ongoing challenges.  The plan is designed to help national regulators to deliver regulation that protects the public while enabling timely access to quality products and encouraging innovation by prioritising regulatory initiatives to help our Member States (MS) increase access to universal health coverage (UHC), support health emergency responses, and promote healthier populations. Read more “WHO outlines five-year regulatory action plan”

FDA releases final guidance on advertising and promotional material submissions

The United States (US) Food and Drug Administration (FDA) have finalised their guidance on the requirements and recommendations for submissions of promotional materials for human prescription drugs and biological products. The FDA stated that they received and considered multiple comments on the need to provide clarity on submission expectations and the technical features of electronic submissions. Read more “FDA releases final guidance on advertising and promotional material submissions”

MHRA opens consultation on the application of analytical quality by design principles to pharmacopoeial standards for medicines

The Medicines and Healthcare Products Regulatory Agency (MHRA) have opened a consultation on their plans to apply analytical quality by design (AQbD) principles to pharmacopoeial standards for medicines. The public consultation closes on 31st August 2019 and the MHRA hopes to learn about the opportunities and challenges relating to pharmaceutical quality, and how AQbD concepts are used by drug manufacturers. Read more “MHRA opens consultation on the application of analytical quality by design principles to pharmacopoeial standards for medicines”

EMA encourages early engagement with medicine developers to help fight antimicrobial resistance

The European Medicines Agency (EMA) have opened up an early dialogue, which is available through its Innovation Task Force (ITF), to all medicine developers working on therapeutic approaches for the treatment or prevention of bacterial and fungal infections. Read more “EMA encourages early engagement with medicine developers to help fight antimicrobial resistance”

European Parliament report explores the challenges of regulating artificial intelligence in healthcare

A report from the European Parliament discussed the concerns regarding the regulation of artificial intelligence and robotics in healthcare settings. Earlier warnings include that the system for approving medical devices may not be suited for the assessment and clearance of artificial intelligence technologies. Read more “European Parliament report explores the challenges of regulating artificial intelligence in healthcare”

How are regulators worldwide looking to harmonise how they tackle innovation?

The International Coalition of Medicines Regulatory Authorities (ICMRA) have released a report which outlines how regulators worldwide are working together to identify and address future regulatory challenges posed by new categories of therapeutics, such as cell and gene therapies, and new tools for drug development, including artificial intelligence. Read more “How are regulators worldwide looking to harmonise how they tackle innovation?”