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”
Year: 2019
European Commission issues additional guidance on device vigilance system
In order to help medical devices manufacturer in their obligations regarding vigilance, the European Commission published a guidance to complement the current guidelines on medical devices vigilance system, MEDDEV 2.12-1 rev 8, 2013. Read more “European Commission issues additional guidance on device vigilance system”
FDA asks for comments on ICH guideline on optimising safety data collection
The United States (US) Food and Drug Administration (FDA) have asked for comments on a guideline from the International Council for Harmonisation (ICH) on how to collect safety data in certain late-stage pre-approval or post-approval studies when the safety profile of a drug is sufficiently characterised. Read more “FDA asks for comments on ICH guideline on optimising safety data collection”
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”
European Commission outlines the impact of Brexit on Good Laboratory Practice
From 1st November 2019, it is likely that the United Kingdom (UK) will no longer be a member of the European Union (EU). The European Commission has outlined the consequences of how EU rules in the field of Good Laboratory Practice (GLP) will no longer apply to the UK after Brexit, however an EU-wide “Mutual Acceptance of Data” (MAD) system will apply. Read more “European Commission outlines the impact of Brexit on Good Laboratory Practice”
European regulators encourage all sponsors to publish clinical trial results in European Union database
The European Medicines Agency (EMA), European Commission (EC) and the Heads of Medicines Agencies (HMA) have sent a letter to clinical trial sponsors reminding them of the requirement to publish the results of all clinical trials conducted in the European Union (EU) in the EudraCT database. Read more “European regulators encourage all sponsors to publish clinical trial results in European Union database”
Highlights from the June CHMP meeting
From their meeting in June, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting the CHMP announced recommendations for three medicines for approval. Read more “Highlights from the June CHMP meeting”
European Commission releases aide-memoire to help medicine manufacturers comply with GMP inspections related to falsified medicines delegated regulation
In order to help medicine manufacturers comply with the 2015 European Union (EU) delegated regulation protecting against falsified medicines, which came into force in February 2019, the European Commission has released an aide-memoire for good manufacturing practice (GMP) inspections of manufacturers. Read more “European Commission releases aide-memoire to help medicine manufacturers comply with GMP inspections related to falsified medicines delegated regulation”
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”
Netherlands and Luxembourg to benefit from EU-US mutual recognition agreement for GMP inspections
The Netherlands and Luxembourg have been added to the mutual recognition agreement for good manufacturing practice (GMP) inspections between the United States (US) Food and Drug Administration (FDA) and the European Union (EU) member states. The FDA can now recognise inspections carried out by regulators from the Netherlands and Luxembourg. Read more “Netherlands and Luxembourg to benefit from EU-US mutual recognition agreement for GMP inspections”