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19 Total results for product and free and sample content found

世界の薬事規制動向&情報を配信

UK Explains New Reliance Routes To Approval Based On EU Dossiers

By Ian Schofield 27 Jan 2021

UK Explains New ‘Reliance’ Routes To Approval Based On EU Dossiers

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

UK BIA To Push For Post-Brexit Regulatory Agreement With EU

By Ian Schofield 27 Jan 2021

UK BIA To Push For Post-Brexit Regulatory Agreement With EU

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

How The UK Regulatory System Would Work In A No-Deal Brexit – Part 1

By Ian Schofield 27 Nov 2020

How The UK Regulatory System Would Work In A No-Deal Brexit – Part 1

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

世界の薬事規制動向&情報を配信

Desperate Measures: How To Soften The Impact Of No-Deal Brexit

By Ian Schofield 27 Nov 2020

Desperate Measures: How To Soften The Impact Of No-Deal Brexit

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

世界の薬事規制動向&情報を配信

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

By Ian Schofield 23 Nov 2020

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

世界の薬事規制動向&情報を配信

Brexit Issues Lead NICE To Delay Methods Review

By Francesca Bruce 23 Nov 2020

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

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