The United Kingdom’s (UK’s) Medicines and Healthcare products Regulatory Agency (MHRA) have added a new section to their “no-deal Brexit” guidance for medical devices, regarding the “UK Responsible Person”. Read more “MHRA update their no-deal Brexit Guidance for medical devices.”
Category: Industry news
What is KASA and how will it affect you? FDA explains plans for the new pharmaceutical quality assessment system.
The US Food and Drug Administration (FDA) has been developing a new pharmaceutical quality assessment system known as the Knowledge-aided Assessment & Structured Application (KASA). Read more “What is KASA and how will it affect you? FDA explains plans for the new pharmaceutical quality assessment system.”
Did you know that the EMA and the US FDA are aligned in more than 90% of marketing authorisation decisions for new medicines?
One of the findings of a joint European Medicines Agency (EMA) and Food and Drug Administration (FDA) analysis compared decisions on 107 new medicine applications at the two agencies for the period 2014 to 2016. The majority of the information used for the study was sourced from EMA’s publicly available European Public Assessment Reports (EPARs) and FDA reviews. Read more “Did you know that the EMA and the US FDA are aligned in more than 90% of marketing authorisation decisions for new medicines?”
FDA finalises guidance on designing nonclinical studies and product labelling for radiopharmaceuticals used in oncology
The United States (US) Food and Drug Administration (FDA) have finalised their guidance on designing nonclinical studies and product labelling for radiopharmaceuticals used in oncology. Read more “FDA finalises guidance on designing nonclinical studies and product labelling for radiopharmaceuticals used in oncology”
British Pharmacopoeia and the United States Pharmacopeia formalise partnership to strengthen the quality of medicines and public health
The British Pharmacopoeia (BP) and United States Pharmacopeia (USP) have signed a memorandum of understanding which formalises their partnership to strengthen quality standards for medicines. Read more “British Pharmacopoeia and the United States Pharmacopeia formalise partnership to strengthen the quality of medicines and public health”
WHO updates guidance on QMS requirements for national inspectorates
The World Health Organisation (WHO) have updated their guidance on quality system requirements for national good manufacturing practice (GMP) inspectorates. The aim of the update is to align with international standards and the latest quality management system (QMS) principles. Read more “WHO updates guidance on QMS requirements for national inspectorates”
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”
Highlights from the June CHMP meeting 2019
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 2019”
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”