News Archive

Brexit: Handling PV Data from the UK

6th March 2019

The European Medicines Agency (EMA) has updated the agency's Brexit-related guidance documents. This guidance is supporting pharmaceutical companies to prepare for the United Kingdom's (UK) withdrawal from the European Union (EU). Now the 'Questions and Answers' document has been updated (Rev 04, published on 1st February 2019). The new Q&As address the situation when the United Kingdom becomes a third country on 30th March 2019 without a withdrawal agreement (and hence without a transition period).

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Brexit-related guidance for companies

25th February 2019

The European Medicines Agency (EMA) and the European Commission are providing guidance to help pharmaceutical companies responsible for both human and veterinary medicines prepare for the United Kingdom's (UK) withdrawal from the European Union (EU), a process known as 'Brexit'.

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MHRA Pharmacovigilance Inspection Metrics

6th February 2019

The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2017 to March 2018.

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EMA - Change of Address

5th February 2019

The EMA London office will close on the 1st March 2019 and re-open on the 4th March in Amsterdam....

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EMA Relocation Updates

23rd January 2019

The European Medicines Agency (EMA) will physically relocate to the Netherlands in early March 2019. The Dutch authorities have already officially handed over the temporary building, the Spark building in Amsterdam Sloterdijk, to EMA’s Executive Director Guido Rasi on 9 January 2019 and EMA is now preparing for its physical move.

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MHRA Guidance in the event of a no-deal Brexit

3rd January 2019

MHRA Guidance on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal....

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MHRA Healthcare Inspector Applications

12th December 2018

The MHRA have recently introduced a new inspector role, the Healthcare Inspector, which is currently open for applications.

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Medical Devices FDA News

11th September 2018

Quality in 510(k) 'Quik' Review Programme Pilot The FDA has launched the Quality in 510(k) ('Quik') Review Programme pilot. The goal of this pilot is to simplify how manufacturers of certain moderate risk medical devices complete a premarket notification (510(k)) submission, and to evaluate whether use of the FDA’s free eSubmitter software will result in well-organised submissions that can be reviewed more efficiently.

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Brexit: EMA updates information for holders of centralised marketing authorisations

7th August 2018

According to the European Medicines Agency (EMA), marketing authorisation holders (MAHs), applicants and sponsors of centrally authorised medicines for human or veterinary use should consider how Brexit will impact their medicines and which changes need to be addressed before the UK leaves the EU. They also need to ensure that the necessary changes are made by that date.

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Brexit - UK Government update on implementation period

6th August 2018

The British Government has issued technical information on what the implementation period means for the life science sector. This includes details on how the EU’s new Clinical Trials Regulation (CTR) will be approached by the UK.

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