In this week’s news, UK is top biotech hub, Fareva calls on FMD experts, US FDA urged to clarify med device app oversight and more…
UK is Europe’s top biotech hub for now…
Europe is fast evolving into a biotechnology innovation hub according to analysis by GEN.
The magazine has ranked the continent’s 10 most exciting biotech clusters, basing its assessment on access to funding, the patent landscape and a measurement of the employment market.
The UK comes out as the number 1 hub, based largely on the number of large biopharmaceutical companies with local operations. Whether the UK can maintain its leading status after Brexit is an open question.
The UK’s impending withdrawal from the European Union (EU) has already seen it lose the EMA, over which it used to have a considerable influence in terms of policy development and drug assessment.
Holland – where the EMA will be based from April – now ranks fourth on the list of clusters according to GEN, which says the country has seen an increase in the number of people employed in biotech in the past two years.
The magazine also points out the UK has fallen further behind Germany and its other European neighbours in terms of the number of biotechnology patents filed since the Brexit vote.
Read the full article here.
Fareva calls on FMD experts
Fareva has hired TraceLink to ensure it is in compliance with EU falsified medicines laws.
The API contractor announced the deal last week, explaining it needed a solution that could ensure compliance ahead of the February 2019 deadline, while enabling successful data exchange.
Fareva sales VP Sebastien Poncet said, “TraceLink stood out as the only provider who had a solution that would eliminate the time-intensive and cost prohibitive task of point-to-point connections, while also allowing us to streamline data exchange with our customers and support them in being compliant with serialization regulations.”
US politicians want FDA to clarify plans for digital health pre-certification
Members of the US Senate have written to the US FDA demanding it answer outstanding questions about how ‘digital health’ software will be monitored.
The letter focuses on how the agency will oversee mobile phone applications that have been classified as medical devices.
The questions cover a range of topics from how the pre-certification program fits with existing statues, how apps will be qualified, how they will be monitored and how their performance will be assessed.
The letter comes just a few weeks after the FDA announced that Apple’s iWatch – which has extensive cardiac monitoring capacity – had been classified as a medical device.
Read more at RAPS.
US FDA will send cGMP declarations to fellow regulators
The US FDA has announced it will share cGMP declarations made by pharmaceutical companies with fellow regulators.
The US regulator published details of the plan last week, explaining the idea is to keep it compatriots informed about the status of current good manufacturing practices (cGMP) assessments.
It said, “upon receipt of a written or email request by an establishment physically located in the US that has been included as part of a marketing application submitted to a foreign regulator, FDA will issue within 30 days of receipt of the request, a written communication to an identified foreign regulator conveying the current cGMP compliance status for the establishment.”
ABPI says things ‘will go wrong’ in UK drug industry due to Brexit
UK drug industry group chief Mike Thompson has told politicians discussing risks of a no-deal Brexit there is not enough time to re-plan the pharma industry.
The ABPI CEO made the comments last week – see footage here – predicting that drug supply and oversight problems will occur if the UK crashes out of the European Union without a trade deal.
He told MPs “Some things will go wrong because we are trying to re-plan a whole industry in a very short space of time.”
Also in the news
Industry group PBOA has shared some interesting analysis of public CDMOs.
The US FDA has approved a record number of generic drugs in the current calendar year. Read more at RAPS.