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Executive Editor, Pharma Insights
UK
+35 year(s) experience
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.
Pink Sheet
The UK medicines regulator has a “unique opportunity” to evaluate the systems it operates and to “do things differently", according to its long-term interim head, June Raine.
Topic Policy & Regulation Brexit
Generics Bulletin
Companies marketing dexamethasone in Europe have been told they can use a CHMP endorsement to request the addition of COVID-19 to their product license.
Pink Sheet
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
With time running out on the UK-EU trade deal negotiations, the UK life sciences industry looks at the fine print of the new guidance on medicines regulation and explains why a mutual recognition agreement is urgently needed.
Topic Pharma-Brexit Regulation Brexit
Pink Sheet
June 24 was a seismic day, in more ways than one. The UK's decision to withdraw from the EU may have elated more than half of the voting public, but it has caused deep disappointment, anxiety and anger among many millions more in the UK, Europe and around the world.
Topic Pharma-Brexit Brexit
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
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
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
Brexit and the NHS are likely to be key issues as political parties in the UK prepare to campaign ahead of the general election in December.
Topic Pharma-Brexit Reimbursement
Pink Sheet
Draft regulations on medicines and medical devices could get caught up in the chaos that seems about to engulf the UK parliament as opposition MPs attempt to avert a no-deal Brexit.
Topic Pharma-Brexit Regulation Brexit
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
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
Pink Sheet
As Brexit uncertainty continues and a “no-deal” scenario remains a possibility, pharmaceutical companies need to be looking at issues such as the renegotiation of supplier contracts, the transfer of key regulatory roles, and the mapping of trade flows, says EFPIA’s president, Stefan Oschmann. Meanwhile, industry and healthcare organizations have drawn up a list of “crucial unanswered questions” that they say the Brexit negotiators must address.
Pink Sheet
If Brexit means the UK no longer plays a part in the EU drug regulatory system, responsibility for the ongoing oversight of almost one in four of all the human medicines that have ever been approved under the centralized procedure will have to be reassigned from the UK to other member states. What Brexit means for the UK’s role as a key player in the regulatory system in the meantime is the subject of speculation.
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27 Oct 2020
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26 Oct 2020
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23 Oct 2020
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21 Oct 2020
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19 Oct 2020
Medtech Insight
16 Oct 2020
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16 Oct 2020
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15 Oct 2020
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14 Oct 2020
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14 Oct 2020
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13 Oct 2020
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13 Oct 2020
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09 Oct 2020
HBW Insight
09 Oct 2020
Pink Sheet
08 Oct 2020
