#ICYMI – CE Marking, Non EU Dossier’s & More Articles From The Archive
In this first ICYMI (In Case You Missed It) of 2019, we look at four articles from the Acorn Regulatory archive. We look at CE Marking a medical device that contains a medicine, the difficulties associated with Type I variations, the issues surrounding non-EU dossier’s and we provide an overview of PSUSA’s.
CE Marking a Medical Device which Incorporates a Medicine
Medical devices come in all shapes and sizes, ranging from wheelchairs to drug-eluting stents and everything in between. All medical devices must meet the requirements of the EU Medical Device Directive 93/42/EEC in order to be CE marked and placed on the European market. However, when a medical device incorporates a medicine there are some specific requirements which must be met. Read more here.
How do you translate your Non-EU dossier for the EU market?
Any regulatory professional will tell you that when you’re developing your new medicinal product your developmental R&D strategy should have your regulatory strategy firmly in sight. This is an ideal that many larger companies successfully perform with ease whereby they develop a global product which has an individualised regulatory strategy for each region firmly embedded in the development process. Read more here.
Type I Variation: Apparently Not So Simple
Regulatory professionals would generally perceive the Type I variation as a fairly simple regulatory procedure. New figures released by the EMA suggest differently. Statistical data released by the EMA has revealed that 44% of all Type I variation applications received for assessment by the EMA contain errors. It is reasonable to assume that these figures are mirrored for National and MRP variations. The figure of 44% is quite high when you consider that the variations classification guideline for Type I variations is quite detailed. The pharmaceutical industry is always pursuing initiatives to achieve “perfection” in our processes. This lean approach increases efficiency, improves quality and achieves what the Pharmaceutical industry is primarily focused on, providing safe and effective medicinal products to the public. The function of Regulatory Affairs is no different. Identifying areas of improvement and increasing “Right First Time” is a goal of all regulatory personnel. This article details the common deficiency areas with the idea of promoting awareness. Read more here.
Periodic Safety Update Single Assessment (PSUSA) – An Overview
The World Health Organisation defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Due to limits of clinical trials, continuing to collect information on a medicine following authorisation is an important way to monitor the safety of medicines.
In Europe, one way regulatory authorities collect this important information is via Periodic Safety Update Reports (PSURs). These documents are intended to provide a thorough analysis of the risk-benefit balance of a medicine taking into account new or emerging safety information. Read more here.
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