COVID-19: Weekly Life Sciences Digest – International Collaboration and Adjusted Exports/Import Rules
With COVID-19 heralding unprecedented changes in the sector, our life sciences products experts provide a weekly summary of key international developments to keep you up to date.
UK-specific guidance for the application and management of clinical trials in the context of COVID-19
The UK’s MHRA has stated it will be particularly flexible and pragmatic in authorising clinical trials connected to COVID-19, referring to its previous track record of having acted swiftly in past public health crises
2020 Vision – Looking Beyond COVID-19: Longer-Term Considerations for Supply and Manufacture of Products During COVID-19
With COVID-19 causing a pivot or volume increase in production, companies should pause to reflect on the longer-term considerations in terms of international product safety, liability and insurance law issues.
The EU has decided to postpone application of its new medical regime by one year. Although COVID-19 is cited as the reason, the delay is no doubt welcomed by an industry that has lobbied for postponement of the regime for some time because of perceived issues with its implementation.
The ever-changing COVID-19 regulatory landscape: The European Commission issues guidance on the manufacture of certain medical supply products for COVID-19
The regulatory environment for rapid production of COVID-19 medical supplies changes on a daily basis. Most recently, the European Commission has weighed in to provide some Europe-wide insight. The guidance provided only serves to underline the significant pressures that all of those in these areas are having to grapple with, as well as the considerable complexity of applicable regulatory regimes.
As noted in our previous overview article, it is vital that interested companies continue to monitor and strategically act on the rapidly changing government position on the regulation of specific medical supply product types in the context of COVID-19.
Extraordinary Times, Extraordinary Measures: How to become a medical supply manufacturer in Europe in the times of the COVID-19 pandemic
The extraordinary times we find ourselves in during the global COVID-19 crisis has led to extraordinary measures being taken by product manufacturers and suppliers across the globe. Regulatory bodies and governments around the world are taking equally unprecedented measures.
Due to some unique aspects of the EU Cosmetics Regulation compared to other EU product safety regulations, the cosmetics industry has been particularly impacted by Brexit. Given that Brexit has now taken place, it is timely to reconsider this ongoing impact on industry and provide some guidance on forward-looking planning.
On 18 February 2020, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), updated its guidance on medicine licensing post-Brexit “Apply for a licence to market a medicine in the UK”. The update provides further clarity on the UK’s status in the licensing process now that Brexit has taken place.