Ian Schofield
Executive Editor, Pharma Insights
Executive Editor, Pharma Insights
UK
+36 year(s) experience
世界の薬事規制動向＆情報を配信
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
Generics Bulletin: ジェネリック＆バイオシミラーニュース
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: 世界の薬事規制と承認審査に関するニュース
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: 世界の薬事規制と承認審査に関するニュース
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: 世界の薬事規制と承認審査に関するニュース
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: 世界の薬事規制と承認審査に関するニュース
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: 世界の薬事規制と承認審査に関するニュース
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: 世界の薬事規制と承認審査に関するニュース
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: 世界の薬事規制と承認審査に関するニュース
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.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
The UK’s departure from the EU imposes a number of requirements on sponsors running EU trials, but it seems that many have still not taken steps to fall into line.
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
The UK's decision to leave the EU will have a wide range of effects on the life sciences sector, from drug approvals and clinical research to data exclusivity, patents and trade.
Topic EU Regulation
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
Authorities Also Investing In Vaccines And Tests Amid concerns that the coronavirus outbreak could have an impact on the supply of APIs and other materials sourced from Chinese manufacturers, pharmaceutical companies are to assess their supply chain situation to help ensure patients do not experience medicine shortages.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
Bluebird bio’s gene therapy Zynteglo, Akcea’s antisense drug Waylivra and BioMarin’s enzyme substitution therapy Palynziq were among the novel innovative medicines that were approved in Europe in 2019.
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
The pharmaceutical industry has come under attack by a UK parliament committee for failing to make medicinal cannabis products available for clinical trials, saying that a "robust research base" is needed on which to base future treatment decisions.
Topic Clinical trials Drug approval
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
Gedeon Richter’s uterine fibroid drug, Esmya (ulipristal acetate), is expected to be the subject of a safety recommendation by the EMA’s pharmacovigilance committee this week.
世界の薬事規制動向＆情報を配信
09 Apr 2021
世界の薬事規制動向＆情報を配信
07 Apr 2021
世界の薬事規制動向＆情報を配信
31 Mar 2021
世界の薬事規制動向＆情報を配信
31 Mar 2021
世界の薬事規制動向＆情報を配信
03 Mar 2021
世界の薬事規制動向＆情報を配信
01 Mar 2021
世界の薬事規制動向＆情報を配信
19 Feb 2021
世界の薬事規制動向＆情報を配信
11 Feb 2021
世界の薬事規制動向＆情報を配信
27 Jan 2021
世界の薬事規制動向＆情報を配信
26 Jan 2021
世界の薬事規制動向＆情報を配信
26 Jan 2021
世界の薬事規制動向＆情報を配信
25 Jan 2021
世界の薬事規制動向＆情報を配信
20 Jan 2021
世界の薬事規制動向＆情報を配信
18 Jan 2021
世界の薬事規制動向＆情報を配信
15 Jan 2021