All Regulatory Rapporteur articles in April 2022

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  • tree

    The future of pharmaceuticals is green


    The healthcare sector is not immune from societal concerns about the environment and will have to go green over the next few years

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    A review of paediatric development challenges, FDA collaboration and future trends


    Susan McCune M.D. Susan McCune M.D., is a paediatrician and neonatologist, with 18 years’ academic clinical and research experience. This was followed by 18 years at the US FDA where, from 2017 to 2021, she was the director of the Office of Pediatric Therapeutics in the Office ...

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    The national competent authorities of Belgium and Luxembourg share their views about the e-PIL Pilot


    Q: Why do the authorities support the e-PIL Pilot and why do you think it is important? A: Iris Geussens: Digitalisation is the future, and the pharmaceutical sector cannot stay behind. The advantage of an electronic package leaflet is that you always have access ...

  • epipen

    Planning for the future: sustainable medical devices


    Pharmaceutical and medical device companies are increasingly looking at new ways to incorporate sustainability into their strategies in a bid to help the environment. While existing medical device standards do not address sustainability explicitly, ISO working groups and others are now considering sustainability as an important component of medical device development. The heavily regulated world of medical devices will likely see sustainability standards emerging in the next decade.

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    Electronic leaflet pilot in Belgium and Luxembourg hospitals


    The e-PIL Pilot was set-up in Belgium and Luxembourg with the objective to demonstrate the equivalence between the paper patient information leaflet and the electronic patient information leaflet in providing information on the safe and effective use of medicines in hospital setting. The first results of the Pilot are promising ...

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    The EU restriction proposal for intentionally-added microplastics: A focus on solid dosage form medicinal products and food supplements


    Among the European initiatives to address the growing concern of plastics in the environment, the European chemicals agency (ECHA) has prepared a restriction proposal for intentionally-added microplastics amid concerns about plastics in the environment. An introduction to the proposal and its impact on consumer products.

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    Meeting Report

    The DIA’s accelerating CMC workshop


    The Drug Information Association’s (DIA) virtual accelerating chemistry, manufacturing, and controls (CMC) workshop, held between 28 to 30 September 2021, consisted of seven sessions. The workshop included presentations by representatives from industry, industry bodies, health authorities and regulatory governance bodies.

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    Terrestrial ecotoxicological studies for veterinary pharmaceuticals in livestock dung in the field: Phase II Tier A and beyond


    The environmental risk from veterinary pharmaceuticals (VPs), which are usually called veterinary medical products (VMPs) must be assessed according to European legislation: in particular, parasiticides that are used for pastured animals (eg, sheep, cattle etc). This is especially true regarding the non-target effects of faecal residues on dung-dwelling organisms. Focusing ...

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    Brexit: The regulatory landscape one year on


    A year since the UK departed from the EU, what has changed? The UK has started to depart from the EU in a number of different ways. This article will explore what has changed, how it came about and what to look out for as the relationship between the UK and EU, as well as the rest of the world, continues to evolve.