Regulatory in brief | AESGP, Denmark, UK

Regulatory in brief | AESGP, Denmark, UK

16 March 2021 - Deborah Wilkes

The Association of the European Self-Care Industry (AESGP) has published a position paper on digitalisation, the director of the Danish Medicines Agency has stepped down, and the UK has updated its guidance for batch testing of imported medicines.

AESGP’s position paper

The Association of the European Self-Care Industry (AESGP) has published a position paper on ‘Paving the way for the digitalisation of the self-care sector’.

The industry association maintains that regulators, policymakers, industry and society at large need to work together if Europe is to become a global leader in the digital health space.

The AESGP agrees that a “solid legal and regulatory framework needs to be in place to protect consumers and bring further trust in innovative digital tools”.

However, it stresses that “such a framework needs to be flexible enough to harness the full potential of digital tools and bring further opportunities to health systems by increasing accessibility and cost-effectiveness of care”.

The paper calls for changes in five areas – real word data, artificial intelligence, product and disease information, building digital workforce capacity and e-commerce.

Change at Danish Medicines Agency

The Danish Medicines Agency has announced that Thomas Senderovitz has stepped down as director after almost five years in the post.

Senderovitz is joining Novo Nordisk as senior vice president with responsibility for data science.

The regulatory agency said a new permanent director would be appointed as soon as possible.

In the meantime, professional director Mette Aaboe Hansen has been named as acting director.

UK updates guidance on batch testing

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance for batch testing of imported medicines following the end of the Brexit transition period.

The UK government had intended to introduce batch testing for medicines imported from the European Union with effect from January 2023.

However, it now plans to continue with the existing system of recognising batch testing from the European Union, and will give companies a notice period of two years before any changes.

The Proprietary Association of Great Britain (PAGB) welcomed the government’s decision not to “conduct checks in the UK which repeat the already-robust procedures followed under European Union testing standards”.

The Association of the British Pharmaceutical Industry (ABPI) noted that “setting up duplicative and unnecessary batch testing operations is a long, complex and costly process”.

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