Regulatory
Rapporteur
Write to the Editor at publications@topra.org
July/August 2024 | Vol. 21 | No.7
EDITORIAL
Sustainable pharmaceuticals
This month’s issue focuses on sustainability. Pharmaceutical sustainability encompasses a broad range of practices aimed at minimising the environmental, social and economic impact of production, distribution and consumption. When integrated into industry, these practices can help create a more responsible sector, balancing the need for innovation and public health with the preservation of the environment and social equity.
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By Davina Stevenson
FOCUS
EMA revises the guideline for environmental risk assessment of medicinal products for human use
The revised guidance on the conduct of environmental risk assessments in the EU becomes effective on 1 September 2024. This article discusses and analyses key changes in the guidance.
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By Sharon Robinson and Kadi Kuuskmae-Perry
FOCUS
The sustainability imperative for the healthcare sector
The healthcare sector has a unique opportunity and responsibility to address its carbon footprint. This article looks at the role regulatory professionals can play in reducing value chain emissions and integrating climate into business strategy.
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By Michael Kipping, Michelle Sullivan, Peter Bannister and Rich Shaw
FOCUS
The relevance of sustainability in regulatory affairs consultancies
Environmental, social and governance (ESG) factors form a framework for approaching and evaluating a company’s sustainability and ethical impact, and help stakeholders and investors evaluate its commitment to responsible business practices. This article explores the value of ESG and how consultancies can develop strategies to address their impact on the planet and society.
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By Shelley Morelli and Zeb Younes
FOCUS
UK ePI Task Force evidence review: electronic patient information leaflets (ePILs)
Several countries have successfully implemented electronic product information and the UK is currently initiating discussions to do so. This evidence review looks at how patients and healthcare professionals currently access paper patient information leaflets and healthcare information, and the challenges and opportunities of the transition from paper PILs to ePILs in the UK.
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By Marie Woe, Erika Aparicio and Kathryn Sharpe
FOCUS
E-labelling: revolutionising the labelling landscape
The implementation of electronic labelling drives efficiencies but also overcomes the limitations and logistical challenges of paper-based labelling. This article looks at new approaches, the benefits and how initiatives are being developed and rolled out globally.
By Sampath Kumar Belide, Arun Arya, Kirti Yadav, Vivek Tomar and Allison Gillespie
FOCUS
Bengt Mattson reflects on sustainability
A summary of a recent interview with Bengt Mattson, Policy Manager at LiF, the trade association for the research-based pharmaceutical industry in Sweden, and his thoughts on sustainability and the potential impact of EU environmental legislation on the pharmaceutical sector.
By Davina Stevenson, based on an interview between Bengt Mattson and Alan Booth
FOCUS
Sustainable design and manufacture in medical devices
Taking sustainability seriously is essential for medical and healthcare businesses, offering tangible benefits and long-term success. In this article, Cormac O’Prey looks at where design and remanufacturing fits into a sustainable business strategy.
By Cormac O’Prey and Davina Stevenson
FOCUS
New approach methodologies for the biological safety assessment of medical devices
New approach methodologies (NAMs) are being actively developed to supplement or replace in vivo testing as part of the drive towards the three Rs of replacement, reduction and refinement of animal experiments. This article provides an overview of NAMs and their recent developments in biological safety assessments, with an emphasis on the application to medical devices.
By Jocivania Oliveira da Silva and Marielle Fournier
FOCUS
Green claims related to animal feed products in the EU: substantiation, labelling and regulatory developments
The European Commission drafted the Green Claims Directive in March 2024 to limit greenwashing by ensuring green claims are properly substantiated. This article provides an overview of the Green Claims Directive and explains its impact on animal feed products, how industry anticipates its enforcement and the challenge it represents.
By Sebastien Oguey, Clementine Oguey and Vera Houriet
STANDALONE
What is involved in the role of the person responsible for regulatory compliance?
The Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) introduced a new role defined in Article 15: the person responsible for regulatory compliance (PRRC). This article discusses the responsibilities of PRRCs, how they are appointed and how they can be supported by TEAM-PRRC, a European non-profit organisation dedicated to the profession.
By Elem Ayne
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