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71 Total results for product and free and sample content found

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

'No Turning Back' On Regulatory Changes at UK MHRA

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-and-regulation brexit

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

UK Votes To Leave The EU – Where Next For The Life Sciences?

UK Votes To Leave The EU – Where Next For The Life Sciences?

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.

Topic Regulation brexit biopharmaceutical

Generics Bulletin: ジェネリック&バイオシミラーニュース

Time Is Short To Prepare For New Post-Brexit UK Regulation

Guidance from the UK’s MHRA on post-Brexit arrangements relevant to the off-patent industry has been welcomed by local industry body the BGMA. However, it has warned that time is short to prepare for the end of the UK-EU transition period, with new guidance in certain areas “critical.”

Topic brexit

Medtech Insight: 世界の医療機器・医療技術の最新情報

Brexit Response: Patient Safety Prioritized In Forthcoming UK MHRA Device Regulatory System

Although the EU MDR and IVDR will fall outside the scope of new post-Brexit medtech regulations for Great Britain in 2021, the UK MHRA says it has the chance of developing its own world-leading regulatory regime.

Topic Medtech-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

UK Explains Approach To Renewing Converted EU Drug Approvals in 2021

The Medicines and Healthcare products Regulatory Agency has put procedures in place to renew UK marketing authorizations that are grandfathered from the EU system after the Brexit transition period ends.

Topic EU 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

Gloom Over Prospects For Brexit Trade Deal

Gloom Over Prospects For Brexit Trade Deal

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

UK Offers Pragmatic Approach To Safety Reporting From Jan 2021

UK Offers Pragmatic Approach To Safety Reporting From Jan 2021

The UK’s approach to pharmacovigilance system requirements in the post-Brexit transition period will allow companies to leverage some of the existing structures put in place for EU systems.

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

The Brexit Timebomb: Expect Effects On Drug Regulation, IP, Research And Trade

The Brexit Timebomb: Expect Effects On Drug Regulation, IP, Research And Trade

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

Medtech Insight: 世界の医療機器・医療技術の最新情報

UK Medtech Industry Advances Its Case For US FTA Amid Ongoing EU Talks

Securing a favorable post-Brexit free trade agreement with the US is the principal aim of the UK’s Department for International Trade, and the UK medtech industry is pressing its case for closer business links with its largest non-EU trading partner.

Topic Medtech-Brexit Brexit Policy & Regulation

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