Regulation

Generics Bulletin reviews global regulatory developments across the world.

MediNatura expands recall to include all lots of both ReBoost and ClearLife nasal sprays after microbial contamination and yeast or mold were found. Firm in 2021 challenged homeopathic drug oversight change from policy in place since 1988.

Joint Singapore-UK plan underlines direction of travel for MHRA after its embracing of international reliance (IR). Australia’s TGA has also broken new ground by recognizing the UKCA mark.

“There's a lot of third-party audit information out there. Could we take that and apply it into our inspectional planning process?” says Office of Dietary Supplement Programs Director Cara Welch.

“We have rarely, if ever, enforced this requirement” FDA says announcing enforcement discretion regarding requirement for disclaimer about supplement structure/function and other label claims to be printed on every panel of a product’s package.

CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.

Sunscreen products industry and public health advocacy groups have been critical that FDA has not approved a new filter since 1999 even as countries in Europe and other regions allow using numerous additional ingredients in sunscreens.

FDA’s proposed order follows its review of OMOR DSM-Firmenich submitted showing bemotrizinol, at concentrations up to 6%, is generally recognized as safe and effective and can be added as an active ingredient to sunscreen monograph.

Responding to the newly-agreed EU pharma package, Medicines for Europe said the deal was a limited political compromise that could have been more ambitious – particularly when it comes to access – but nevertheless represented “an important step forward” and “progress” for the EU pharma sector.

“Section viii cannot function as Congress intended,” if a Federal Circuit ruling stands, the US solicitor general has argued as he urged the Supreme Court to review and reverse the closely-watched Hikma skinny-label Vascepa case.

FDA looks to Congress for authority to require registration for all supplements available for sale in US for public-facing product listing but no authority can produce list of dietary ingredients available pre-DSHEA.

The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.