Life Sciences weekly highlights—10 June 2021

Published on: 10 June 2021

Published by: LexisPSL

Life Sciences weekly highlights—10 June 2021
In this issue:
Manufacture, marketing and sale
ATMP trade organisations call for GMO exemption in EU
Commission publishes plan for Regulation (EU) 2017/746, the IVDR
PMCPA announces consultation of amendments to 2021 ABPI Code template
MDCG publishes guidance in implant cards
FAQs published on European Medical Device Nomenclature
MDCG explains how IMDRF N48 guidance applies to MDR and IVDR
Research and development

More...

Therapeutics and Vaccines Clinical Trials Charter agreed by G7 health ministers
Further £1m pledged to develop treatments for antibiotic-resistant infections
Coronavirus (COVID-19)
MHRA approves use of Pfizer coronavirus (COVID-19) vaccine for ages 12–15
Government launches partnership to expedite future pandemic responses post-coronavirus (COVID-19)
Coronavirus (COVID-19)—Commons examines COVAX Initiative
Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment) Regulations 2021
EMA highlights importance of evidence from observational studies
UK/EU divergence—have your say
Daily and weekly news alerts
New and updated content
Updated Practice Notes
Dates for your diary
Trackers
Latest Q&A
New module—Lexis®PSL EU Law
Useful information

Article summary

This week's edition of Life Sciences weekly highlights includes analysis of a paper calling for the relaxation of EU regulations that treat advanced therapy medicinal products (ATMPs) as genetically modified organisms (GMOs), details about the Commission’s newly published implementation and preparedness plan for the In Vitro Diagnostic Medical Devices Regulation (IVDR), and news of G7 health ministers agreeing to the Therapeutics and Vaccines Clinical Trials Charter, which aims to improve the efficiency of evidence from vaccine and therapeutic trials. Sign in or take a trial to read the full analysis.