Regulatory in brief | Europe, global collaboration, US

Regulatory in brief | Europe, global collaboration, US

28 April 2020 - Deborah Wilkes

In response to the COVID-19 pandemic, the European Council has adopted the European Commission’s proposal to postpone by one year the date of application of the new Medical Devices Regulation, regulatory agencies around the world have stepped up global collaboration, and the US has taken action on hand sanitisers.

European Council votes to postpone device regulation

The European Council has adopted the European Commission’s proposal to postpone by one year the date of application of the new Medical Devices Regulation.

The European Parliament has already adopted the proposal which will see the date of application put back to 26 May 2021 (click here to read the News story).

The proposal will enter into force once it has been published in the Official Journal of the European Union.

Commenting on the proposal in early April, the European Commission said the move would “allow member states, health institutions and economic operators to prioritise the fight against the coronavirus pandemic” (click here to read the News story).

Regulators step up global collaboration

Regulatory agencies around the world have pledged their collective support to combat the COVID-19 pandemic.

The International Coalition of Medicines Regulatory Authorities (ICMRA) said its members had stepped up global collaboration to “facilitate and expedite” the development and evaluation of diagnostics and therapeutics including possible vaccines.

Guido Rasi, chair of the ICMRA and executive director of the European Medicines Agency (EMA), said the COVID-19 pandemic affected the “whole world and the best way to fight it was through globally concerted actions”.

“Our collaboration as regulators is crucial to increase the efficiency of regulatory processes and decision-making that will facilitate rapid development, approval and global rollout of safe and efficacious medicines against COVID-19,” added Rasi.

In a joint statement, the 29 members of the ICMRA urged governments and the international research community to “prioritise large, well-designed, controlled clinical trials because they are most likely to generate the robust evidence for the safety and efficacy of proposed therapies for COVID-19 needed for decision-making by regulators”.

The ICMRA members emphasised their commitment to a global approach to achieve equitable access around the world to therapeutics and vaccines against COVID-19 and they also called on the pharmaceutical industry to step up its cooperation on therapeutics development and jointly address drug supply issues, shortages and decreased manufacturing capacities.

In addition to Europe’s EMA, members of the ICMRA include Australia’s Therapeutic Goods Administration (TGA), the European Commission, Japan’s Ministry of Health, Labour and Welfare (MHLW), Switzerland’s Swissmedic, and the US Food and Drug Administration (FDA).

US FDA takes action on hand sanitisers

The US Food and Drug Administration (FDA) is taking steps to ensure alcohol-based hand sanitisers remain available and are safe to use amid the COVID-19 pandemic.

The regulatory agency said more than 1,500 additional manufacturers had registered to produce alcohol-based hand sanitisers.

Stephen Hahn, commissioner of the FDA, commented that the agency appreciated “industry’s willingness to help supply alcohol-based hand sanitiser to the market to meet the increasing demand for these products”.

However, Hahn stressed that hand sanitisers should be manufactured in a way that made them unpalatable to people, especially young children, and that product labelling should discourage accidental or intentional ingestion.

The FDA pointed out that adding denaturants to alcohol used in the manufacture of hand sanitisers made the product more bitter and less appealing to ingest.

Hahn also highlighted that hand sanitisers were not proven to treat COVID-19.

The FDA said it had recently issued its first warning letter for a hand sanitiser marketed with unproven COVID-19 related claims. The letter was sent to Prefense LLC.

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