Regulatory
Rapporteur

 

Write to the Editor at publications@topra.org

April 2022  |  Vol. 19  |  No.4

 

EDITORIAL

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. This month’s focus articles explore the varied issues that the healthcare sector is facing regarding sustainable operations.

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 By Birgit Roser and Stephen Dew

 

INTERVIEW

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

Iris Geussens, Head of the Marketing Authorisation Division, and Dr Anna Chioti, Head of the Pharmacy and Medicines Division, both at the Federal Agency for Medicines and Health Products, discuss industry’s changing attitude to digitalisation and the benefits in moving towards an electronic patient information leaflet.

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 By Nathalie Lambot and Marie Vande Ginste

 

FOCUS

Planning for the future: sustainable medical devices

Pharmaceutical and medical device companies are increasingly looking at new ways to incorporate sustainability into their strategies. 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. This article will consider some of the tools that companies can use to start planning for more sustainable outcomes.

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 By Alastair Willoughby

 

FOCUS

Electronic leaflet pilot in Belgium and Luxembourg hospitals

The electronic leaflet pilot was set up in Belgium and Luxembourg to demonstrate the equivalence between the paper and electronic patient information leaflet in providing information on the safe and effective use of medicines in hospital setting. This article discusses the learnings from this pilot.

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 By Nathalie Lambot and Marie Vande Ginste

 

FOCUS

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. This article provides an introduction to the proposal and its impact on consumer products.

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 By Pilvi Jalonen

 

FOCUS

Terrestrial ecotoxicological studies for veterinary pharmaceuticals in livestock dung in the field

The environmental risk from veterinary medicinal products (VMPs) must be assessed according to European legislation. Focusing on dung organism communities, this article provides a guide to the standardised test methods for VMPs.

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 By Jörg Römbke

 

INTERVIEW

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

Susan McCune, Director of the FDA’s Office of Paediatric Therapeutics between 2017 and 2021, discusses the challenges in paediatric development and her thoughts on future trends.

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 By Catriona Roscoe-Cutting and Charity-Anee M. Schuller

 

STANDALONE

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.

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By Tracey Roberts and Natalie Coan

 

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. This report discusses the workshop, which included presentations by representatives from industry, industry bodies, health authorities and regulatory governance bodies.

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By Marie Ward

 

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