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Executive Editor, Pharma Insights
UK
38+ years of experience
Pink Sheet
By Ian Schofield 08 Apr 2021
The team behind Sputnik V has attacked what it calls “fake news and provocations” in the EU as political arguments over the vaccine claim another ministerial scalp.
Pink Sheet
By Ian Schofield 27 Jan 2021
Companies seeking marketing authorizations in the UK or Great Britain will be able to make use of two new “reliance” procedures offering regulatory assessment times of 67 days or less if their products have already gone through the EU centralized or decentralized approval systems.
Topic Brexit Pharma-Brexit
Pink Sheet
By Ian Schofield 27 Jan 2021
There may not be a great deal in the new UK-EU trade and cooperation deal for the life sciences industry but a new working group could act as the forum for constructive discussions on regulatory cooperation.
Topic Regulation Brexit Pharma-Brexit
Pink Sheet
By Ian Schofield 19 Jan 2021
The number of new drugs containing new active substances approved in the EU rose significantly in 2020, underpinned by a strong showing for orphan-designated products and a string of novel medicines for cancer and infectious diseases. Notable among the new clutch of approvals was the first ever COVID-19 vaccine, Pfizer/BioNTech's Comirnaty.
Pink Sheet
By Ian Schofield 04 Jan 2021
The UK regulator, the MHRA, has published guidance on its new integrated pathway for innovative drug approvals, which it says is intended to bring together partners including health technology assessment agencies, health care bodies and patient organizations to offer “sustained collaboration” with drug developers.
Pink Sheet
By Ian Schofield 27 Nov 2020
Building more cold chain warehouses, finding alternative sources of medicine supplies, and halting parallel exports to mitigate product shortages. Just some of the ideas for tackling the consequences of a no-deal Brexit scenario put forward by industry representatives at a recent parliamentary committee hearing.
Topic Pharma-Brexit Brexit EU
Medtech Insight
By Ian Schofield 27 Nov 2020
As negotiators struggle to reach agreement on the future UK/EU relationship following Brexit, suppliers have been warned to expect major hold-ups next year for medical products crossing the English Channel.
Pink Sheet
By Ian Schofield 27 Nov 2020
Could the UK carry on playing a part in the European Medicines Agency from 2021? Much will depend on the complex negotiations on the future relationship that are expected to kick off in March.
Pink Sheet
By Ian Schofield 23 Nov 2020
From next year, owners of trademarks and other rights in the European Economic Area will be able to prevent the parallel export of medicines from the UK to the EEA. But those owning similar rights in the UK will not be able to stop parallel imports from EEA countries.
Topic EU Pharma-Brexit Brexit
Pink Sheet
By Ian Schofield 17 Nov 2020
Following a Brexit-induced delay over the summer, England's HTA body NICE has come up with a concrete set of proposals that it says will help it “robustly and efficiently” evaluate innovative technologies such as advanced therapies, histology-independent cancer treatments, and technologies for rare diseases. Industry bodies have welcomed the plans, which have just been put out for consultation.
Pink Sheet
By Ian Schofield 09 Oct 2020
Delegates at this week’s TOPRA conference heard the European Commission’s “holistic” vision of what it would like to achieve through its pharmaceutical strategy, including incentives for innovation, security of the supply chain, product shortages, real world evidence and big data, and the availability and affordability of medicines.
Pink Sheet
By Ian Schofield 10 Sep 2020
UK vote to leave the EU opens the prospect of years of negotiations over the union's future relationship with one of its most valued member states.
Pink Sheet
By Ian Schofield 26 Aug 2020
As the UK prepares to leave the EU, the life sciences industry has urged the government to seek the maximum regulatory alignment and cooperation with the EU. But time is tight, there is much to do, and the industry may struggle to get its voice heard.
Topic Regulation Brexit
Pink Sheet
By Ian Schofield 26 Aug 2020
The Conservative Party's victory in the UK general election means the Brexit withdrawal deal will be able to pass. The UK will leave the EU by 31 January and enter a transition period during which medicines regulation will remain broadly unchanged.
Topic Regulation Brexit Pharma-Brexit
Pink Sheet
By Ian Schofield 25 Aug 2020
The Northern Ireland Protocol brings added complexities that for medicines regulation in the UK, particularly in areas such as new drug approvals and batch release procedures.
Pink Sheet
15 Jul 2022
Medtech Insight
13 Jul 2022
Pink Sheet
12 Jul 2022
Pink Sheet
11 Jul 2022
Pink Sheet
07 Jul 2022
Pink Sheet
01 Jul 2022
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30 Jun 2022
Pink Sheet
29 Jun 2022
Pink Sheet
27 Jun 2022
Pink Sheet
22 Jun 2022
Pink Sheet
17 Jun 2022
Pink Sheet
15 Jun 2022
Pink Sheet
14 Jun 2022
Pink Sheet
13 Jun 2022
Pink Sheet
30 May 2022
