Pink Sheet

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

In Vivo

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

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

Pink Sheet

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

Medtech Insight

FDA Launches Pilot Program To Streamline EtO Facility, Process Changes

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

Medtech Insight

FDA Clears CDC Diagnostic For COVID-19 And Influenza

The US FDA has authorized marketing of a combination diagnostic that can detect either COVID-19 or influenza. The agency hopes to encourage development of additional similar tests before the fall flu season.

Topic Coronavirus Diagnostics In Vitro Diagnostics Regulation

Pink Sheet

EU Countries Test Offering Simultaneous Scientific Advice

An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.

Topic EU Innovation Regulation

Pink Sheet

China Regulatory Express Former CFDA Commissioner Bi Makes Comeback

Ex-China FDA Commissioner Bi Jingquan’s new role, a waiver of bioequivalence testing for hundreds of drugs, data accuracy requirements and a new crackdown on compliance issues.

Topic China Regulation Compliance

Generics Bulletin

Celltrion's Remsima SC Ready For Early 2020 Launch

Celltrion says it is ready to roll out its Remsima SC subcutaneous infliximab in Europe in the first quarter of 2020, after receiving a formal pan-European marketing authorization from the European Commission.

Topic Biosimilars Launches Regulation

Medtech Insight

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