有感今日MHRA所发的博客

郦无悔

今天MHRA又更新博客了
https://mhrainspectorate.blog.go ... ut-to-case-studies/
题目是:
MHRA support for innovation - Inspectorate input to case studies

MHRA支持创新innovation, 有专门的机构, 办公室
但更感兴趣的, 是他们发的几个case studies案例研究, MHRA到底是怎么支持的呢?
https://www.gov.uk/government/ca ... -manufacturing-site
MHRA helps in the development of a UK manufacturing site for BTG plc for varicose veins treatment

看了这个想撞墙去

BTG这家公司有个新产品, 要新建厂房, 选来选去呢决定在UK建厂. 于是乎, MHRA就去给予帮助了:
MHRA helped by:
responding quickly to an early request for engagement in the project
在项目合约的早期需求方面快速回应
reviewing early plans and advising on regulatory requirements
审核早期计划并在法规需求方面给予建议
acting as a sounding-board to help BTG make the right decisions at the right time
作为"回响板"的角色 (被征询意见者), 帮助BTG在正确的时间做出正确的决定
helping BTG to mitigate risk and overcome challenges
帮助BTG规避风险以及克服这些挑战

这简直就是不要钱的极有权威性的给力咨询公司啊!

感慨一下, 感慨一下...

北重楼

真的假的呀，还有这好事

胜利者

纳税人的荣耀

beiwei5du

在现在的中国你得出钱出面子去请官老爷！

beiwei5du

While the focus is on supporting and encouraging organisations with their innovation, the Innovation Office also benefits MHRA by helping us to learn about early-stage developments and trends, which are then fed into our horizon-scanning activities. This helps keep us well informed about emerging technologies, medicines or devices that may have an impact on future regulation and the development of standards or controls. It also allows us to formulate appropriate strategies to take account of emerging trends.
其实这个是企业和监管部门互赢的利好活动。让监管部门和被监管企业走得更近，互相提高，这个才是政府监管机构的职责！面对中国的现状，有时不得不感叹！

beiwei5du

Gerald Heddell, Director of Inspection, Enforcement and Standards Division, MHRA, said:

“We’re here, not just to regulate, but to listen – to ensure organisations of all sectors and sizes that are developing innovative medicines and products can access world-class regulatory and scientific advice. It’s our goal to support companies in their challenges to develop medicines and devices that benefit public health and patient safety, positively influencing and affecting health outcomes for people around the world.”
我也接着楼主的贴感叹一下！

klanfang

以前有帮监促之说，出了那事之后就不玩了。

4__ur__love

在中国基本是不可能的，官本位太严重了，从奴隶社会开始就形成的，基本上不可能改变的。

4__ur__love

Gerald Heddell, Director of inspection, enforcement and standards division, MHRA, said:

We at MHRA welcome early approaches from companies who need access to expert knowledge, guidance and experience of regulatory processes. As well as being a regulator, we also recognise the importance of supporting companies in their planning processes, in order to ensure positive outcomes for public health.

syhorchid

了解一下

ceq518

不一定就是好事啊！

海阳山山

还是很负责任的职能部门。去年因为对法规的理解写邮件、打电话给WHO的官员，都没有回复的。至少MHRA表现出来的态度是温暖人心的。

xqliu

学习一下啦，谢谢提供分享。以前的药管局有一项职责参加企业的汇审，现在没人做了。