Regulation of chemicals
Published 6th December, 2020 by Elinor Davies, Hazards Forum Head of Marketing and Communications
On the 1st of December 2020, we hosted an hour long webinar, attracting a wide audience that learned about manufactured chemical products and the ever-present issues that remain with their regulation. From time to time, chemicals come back into the public eye, whether in the context of a disaster (e.g., the recent explosion in Beirut) or the need to rapidly develop new products (e.g., to tackle the Covid-19 coronavirus).
When it comes to regulating chemicals, the main concerns that the speakers addressed, were risk management, in particular safety evaluation and manufacture through to distribution, use and disposal. Issues will also vary between single products (e.g., fertilisers, cleaning agents and drugs) and products in combination (e.g., implantable medical devices).
Split into two sessions – Session Two will be confirmed for 2021 and include presentations from other regulators within this discipline – Session One brought together key regulators to discuss existing approaches and the policy and practical challenges for the future. This session allowed specialists from the Medicines & Healthcare Products and Regulatory Agency (MHRA) to discuss existing approaches and what future holds in relation to medical products and medical devices. Biocompatibility Specialist, Sophie Clewlow emphasised that the intended use and relevant endpoints are as key in determining the classification and regulation of a medical device as for a medicine or a vaccine, in her presentation, ‘Biological evaluation of medical devices – The importance of input assessment’.
Sophie explained that Biocompatibility (the response in humans) is usually evaluated for devices by means of a risk assessment process that is based on toxicological data and expert judgement and in keeping with ISO standards. Their presentation highlighted that testing in animals is now only justified if that is not possible. In addition to this, because the world is in times of unprecedented public health need (e.g., tests for Covid-19 coronavirus), fast-track approval of medical devices manufacture can therefore go ahead based upon this process, so long as the input parameters are tightly controlled.
During MHRA’s expert Pharmaco-Toxicologist, David Jones’ presentation, ‘Regulatory Challenges for the Evaluation and Supply of Vaccines and Treatments for COVID-19’, he expressed the challenges in the evaluation and rollout of vaccines. The recent need to expedite vaccine manufacture and clinical trials, as well as to repurpose medicines for Covid-19, has led to very wide collaboration between MHRA, pharmaceutical companies and academia, leveraging pre-existing knowledge and pathways, as well as using a rolling process of data review. David also raised the issues with risk management in the re-purposing of medicines, along with the future challenges in areas of innovation in medicines.
As of next year, MHRA will be the UK’s standalone regulator of medical products, therefore the success of these approaches has meant that they and other initiatives will be fed back into how the agency operates.