Ireland’s healthcare products regulator HPRA says it is taking steps to deal with possible supply interruptions as a result of Brexit, and that it is ready to assume some of the regulatory workload that will result from the European Medicines Agency’s departure from the UK. A stakeholder workshop will be held at the end of August where pharma firms and distributors will be able to discuss Brexit-related concerns with the regulator.
The Irish Healthcare Products Regulatory Agency has set up an internal working group to ensure it is prepared for the implications of Brexit, including potential medicines shortages, and says it is happy to take on more EU regulatory work after the UK leaves the EU.
The new group has already met and is considering “both the risks and the opportunities presented by Brexit,” the HPRA...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
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