The UK’s Medicines and Healthcare products Regulatory Authority (MHRA), the US Food and Drug Administration (FDA) and Health Canada have recently published a joint statement identifying ten guiding principles to help inform the development of Good Machine Learning Practice (GMLP).
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FDA Guidance on Clinical Investigators Signing Form FDA 1572 and Practical Challenges Outside the US
In May 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance (Draft Guidance) addressing the requirement for all investigators involved in clinical trials conducted under a U.S. Investigational New Drug (IND) application to sign Form FDA 1572.…
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European Commission proposal to delay application of In Vitro Diagnostics Regulation
Following increasing pressure from industry and patient groups alike, yesterday (14 October) the European Commission published its proposal to delay the application of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) by amending the transitional provisions for certain…
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European Commission launches consultation on reform of EU pharmaceutical legislation
On 28 September 2021, the European Commission took another step in the implementation of its new pharmaceutical strategy (discussed in more detail in our previous blog posts on the strategy, proposed amendments to orphan and paediatric legislation and…
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Consultation on framework for medical devices in UK
On 16 September, the MHRA published its long awaited consultation on the regulatory framework that will govern medical devices in the UK. This follows the publication in July of the MHRA Delivery Plan for 2021-2023, which made clear that the…
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EMA Reflection Paper on Good Manufacturing Practices and Marketing Authorisation Holders
By Ewan Townsend & Peter Saban
After a public consultation last July, the EMA published its Reflection Paper on Good Manufacturing Practice (GMP) and Marketing Authorisation Holders (MAH) on 23 July 2021. The Paper aims to clarify the responsibilities of the MAH in the GMP guidelines…
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Industry’s response to the Commission’s proposed amendments to the EU orphan and paediatric legislation
We discussed in previous posts the Commission’s announcement at the end of 2020 of its new pharmaceutical strategy for the EU. One topic identified as in need of revision was the unmet medical needs in areas currently not within the…
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Recent GDPR developments relevant for the life sciences sector
On 7 July 2021, the European Data Protection Board (EDPB) adopted the final version of its guidelines 07/2021 on the concepts of controller and processor in the General Data Protection Regulation (GDPR) (Guidelines), following a period of public consultation regarding…
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European Commission’s proposed amendments to orphan and paediatric legislation
As we have discussed in previous posts, at the end of 2020, the European Commission set out its vision to build a European Health Union with its announcement of the new pharmaceutical strategy for Europe (the new Strategy). In…
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AI and IP: Implications for digital health from possible reforms to UK IP law
The use of artificial intelligence (AI) and machine learning is growing at a significant pace and spreading across many industry sectors, including healthcare. With the rapid development of AI technology which has the potential to revolutionise many aspects of our…
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