Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Brexit: New Rules Will Hit Parallel Trade From UK to EU

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

Medtech Insight: 世界の医療機器・医療技術の最新情報

50 Days To Brexit – And No Extension, Govt Warns UK Medtechs

High level EU-UK negotiations have yet to deliver a free trade deal. Meanwhile, the MHRA has issued more guidance for medtechs accessing the UK market in 2021.

Topic EU Medtech-Brexit Brexit

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Brexit Issues Lead NICE To Delay Methods Review

England’s health technology appraisal body, NICE, and the UK medicines regulator, the MHRA, are working together to align their process timelines so that access to medicines is “maintained and enhanced.”

Topic brexit Pharma-Brexit EU

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

NICE Reform Plans Aim To Help Make Post-Brexit UK A 'First Launch' Country

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.

Topic Brexit EU

Medtech Insight: 世界の医療機器・医療技術の最新情報

How To Register In Eudamed By The December Start Date Commission Explains

The start date for voluntary registration in the Eudamed 3 database is fast approaching. It is open to all medtech manufacturers with CE marked medical devices from 1 December

Topic EU medtech

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

England's HTA Body To Revamp Product Selection Processes

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

Medtech Insight: 世界の医療機器・医療技術の最新情報

EU Faces MDR Failure Unless It Adjusts To COVID-19 Crisis And Grows Notified Bodies

Is the current pandemic too big a hurdle for the EU’s medtech regulators and industry alike? What else might hold EU medtech back from the successful implementation of the MDR?

Topic EU policy-and-regulation

Medtech Insight: 世界の医療機器・医療技術の最新情報

COVID-19 Has Prompted An 18-Fold Increase In German IVDs Production Capacity

How coronavirus affects IVDs businesses depends on the branch of the industry they are in, a German survey of manufacturers shows. German labs performed one million COVID-19 tests last week.

Topic Coronavirus EU policy-and-regulation