EU chemicals regulation nears final stages
This article was originally published in Clinica
Executive Summary
The European Parliament's environment and public health committee was due to vote on the draft EU chemicals regulation, REACH, on October 4. This is the last of ten EP committees to give its opinion on the text; over 1,000 amendments by five committees were adopted in mid-September. The aim of the text is to prevent exposure to unsafe chemicals, but the European Commission has also stressed the need to safeguard the competitiveness of Europe's industry - and SMEs in particular. The final text may impact the medical device and diagnostics industry's access to materials used in the manufacture and sterilisation of its products. Rapporteur Guido Sacconi now faces the task of having to bring all the amendments together. He fears that so many changes may water down REACH's initial aims of replacing hazardous products, placing a burden of proof on industry and not overloading the future European Agency for Chemical Products. The text will begin to be debated at the Council from this week.
You may also be interested in...
Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings
Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.