Regulatory

A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.

Tariffs on imports from China and look at eliminating self-affirmed GRAS pathway introduced under Trump while DoJ Consumer Protection Branch also continues supplement sector priorities enduring across administrations.

Sales of Bioventra’s probiotic put inventory at “a critical low” as “parallel rise in unverified listings on third-party marketplaces prompted concern among” customers. DoJ and food and drug industry attorney say counterfeiting remains a problem in supplement sector.

Sponsors of three drugs that are in the final stages of the EU regulatory review cycle are due to make the case for marketing approval before the European Medicines Agency.

A decision from the FDA is due by 28 September.

The European Medicines Agency is this week set to issue an opinion on whether pan-EU marketing should be granted to Lilly’s Alzheimer’s disease drug donanemab.

Generics Bulletin reviews global regulatory developments across the globe.

Britain’s medtech system progress, smarter ways of working at the agency and getting smarter AI and digital technologies into circulation for patients, were themes woven through the UK MHRA board’s 18 March meeting.

FDA testing of 95 benzoyl peroxide products due to concerns about elevated benzene detected by third-party testers found 90% with undetectable or extremely low benzene levels.

The Member State Coordination Group on HTA has also resolved to improve information sharing with drug developers to improve resource planning for EU-level joint clinical assessments.