TrialScope Disclose: The most widely used pla...

Disclosure & transparency experts discuss the ins and outs of CTIS

31 Mar 2022

Disclosure & transparency experts from Sarepta, Boehringer Ingelheim, Bayer and Merck KGaA discuss the ins and outs of CTIS.

Topic Regulation

Topic Regulation

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

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

In Vivo: 医療用医薬品・医療機器産業の経営層向けニュース

The Times They Are A-Changin’: Opportunities In Medtech Regulation For The UK After Brexit

27 Jan 2021

The turn of the year is a chance to reflect on times past and the future, to make resolutions and look ahead to changes for the better. With Brexit in mind, this is the time to prophesize on UK medtech’s immediate future.

Topic Regulation Market Access Medtech-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

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

Medtech Insight: 世界の医療機器・医療技術の最新情報

FDA Launches Pilot Program To Streamline EtO Facility, Process Changes

By ferdous-al-faruque 27 Nov 2020

As concerns continue to mount over a potential shortage of medical devices due to the closure of ethylene oxide (EtO) facilities, the US agency is looking for nine sterilizers in a pilot project that could allow them to get facility and process changes approved faster.

Topic Approvals Compliance Regulation