Ian Schofield
Executive Editor, Pharma Insights
Executive Editor, Pharma Insights
UK
37+ years of experience
Generics Bulletin: ジェネリック＆バイオシミラーニュース
By Ian Schofield 11 Jun 2021
As part of its drive to maximize global access to coronavirus vaccines, the Medicines Patent Pool has developed a publicly accessible resource giving information on the patent status of approved and candidate vaccines.
世界の薬事規制動向＆情報を配信
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.
世界の薬事規制動向＆情報を配信
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
世界の薬事規制動向＆情報を配信
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
世界の薬事規制動向＆情報を配信
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.
世界の薬事規制動向＆情報を配信
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.
世界の薬事規制動向＆情報を配信
By Ian Schofield 27 Nov 2020
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: ジェネリック＆バイオシミラーニュース
By Ian Schofield 27 Nov 2020
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
世界の薬事規制動向＆情報を配信
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: 世界の医療機器・医療技術の最新情報
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.
世界の薬事規制動向＆情報を配信
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.
世界の薬事規制動向＆情報を配信
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
世界の薬事規制動向＆情報を配信
By Ian Schofield 23 Nov 2020
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
世界の薬事規制動向＆情報を配信
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.
世界の薬事規制動向＆情報を配信
By Ian Schofield 29 Oct 2020
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
世界の薬事規制動向＆情報を配信
15 Jul 2022
世界の薬事規制動向＆情報を配信
15 Jul 2022
世界の薬事規制動向＆情報を配信
13 Jul 2022
世界の薬事規制動向＆情報を配信
13 Jul 2022
Medtech Insight: 世界の...
13 Jul 2022
世界の薬事規制動向＆情報を配信
12 Jul 2022
世界の薬事規制動向＆情報を配信
12 Jul 2022
世界の薬事規制動向＆情報を配信
11 Jul 2022
世界の薬事規制動向＆情報を配信
08 Jul 2022
世界の薬事規制動向＆情報を配信
07 Jul 2022
世界の薬事規制動向＆情報を配信
01 Jul 2022
世界の薬事規制動向＆情報を配信
30 Jun 2022
世界の薬事規制動向＆情報を配信
29 Jun 2022
世界の薬事規制動向＆情報を配信
28 Jun 2022
世界の薬事規制動向＆情報を配信
27 Jun 2022
