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Executive Editor, Pharma Insights
UK
+36 year(s) experience
Pink Sheet
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
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
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
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
Regulations that would allow the UK MHRA to work as a standalone regulator in the event of a no-deal Brexit have been laid before parliament. They cover a host of areas including new drug approval procedures, conversion of existing EU marketing authorizations into UK ones, pediatric and orphan exclusivities, imported medicines, and regulatory fees.
Topic Pharma-Brexit Brexit Regulation
Generics Bulletin
A second wave of COVID-19 infection later this year would put even greater pressure on drugs used in patients hospitalized with serious respiratory problems, a new report warns.
Topic Coronavirus Distribution
Pink Sheet
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
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
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
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
The UK medicines regulator has written to pharmaceutical companies outlining the actions they need to take regarding products with a centralized EU approval that will be converted to Great Britain marketing authorizations next year.
Topic Pharma-Brexit Brexit Approvals
Pink Sheet
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
Updated guidance from the UK regulator, the MHRA, outlines the rules on orphan drug applications, criteria and exclusivity periods that will apply in Great Britain after the end of the Brexit transition period
Topic Pharma-Brexit Rare Diseases
Pink Sheet
Proposals from NICE now under consultation are intended to boost the health technology assessment body’s efficiency, improve transparency and governance, and raise the quality of its guidance
Topic Regulation EU
Pink Sheet
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.
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09 Apr 2021
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08 Apr 2021
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07 Apr 2021
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06 Apr 2021
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01 Apr 2021
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31 Mar 2021
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31 Mar 2021
Scrip
31 Mar 2021
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30 Mar 2021
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29 Mar 2021
Generics Bulletin
12 Mar 2021
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12 Mar 2021
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09 Mar 2021
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08 Mar 2021
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05 Mar 2021
