Regulation

Sleep, pain, allergy and women's intimate health among the categories that the UK Department of Health and Social Care would like to see manufacturers submit Rx-to-OTC switch applications for.

Electronic product information should be “fully operational” within four years after the entry into force of the revised EU pharma legislation and should precede the phasing out of paper leaflets, proposes the Inter-Association Taskforce (IATF) on ePI. Once the new system is up and running, ePI should be implemented across the EU in a harmonized way, with all EU member states adopting the same standard, it says.

“The SVA has missed an opportunity to make an important contribution to patient safety and to strengthening personal responsibility,” commented Pharma Deutschland deputy general manager Elmar Kroth.

Critics of requirements that sponsors first demonstrate conventional labeling wouldn’t support an OTC switch before submitting proposals for ACNU switches and for simultaneous availability of Rx formulations of approved ACNU switches likely look to delay as chance to convince the agency to strike one or both components of the final rule.

A recent ASA case involving an ad for vape products shows that marketers shouldn’t assume that professional online networks like LinkedIn are any different to other social media platforms when it comes to UK advertising codes.

Today, Germany's switch committee, the SVA, will consider an application for exemption from requirement for sildenafil in 25mg and 50mg strengths. This is the third time the switch has been put to the committee, which has rejected it twice before.

Australian government finds an insufficient body of new evidence to support Rx-to-OTC switch of erectile dysfunction drug sildenafil since it was last considered in 2020.

FDA Office of Nonprescription Drugs explains in its proposed commitment letter for fiscal years 2026-2030, based in part on suggestions by stakeholders, that it will heighten its attention to collecting those fees.

The Washington State Department of Ecology publishes ‘Interim Policy on Lead in Cosmetics’ which provides safe harbor options for cosmetic products struggling with the 1ppm limit under the state’s Toxic Free Cosmetics Act, while the department gathers information under a newly opened rulemaking to ‘identify a feasible approach to regulating lead in cosmetic products.’

Biovanta’s products relieved symptoms faster than OTC drugs available under FDA monograph, according to clinical trial by brand owner Applied Biological Laboratories. Chief scientific officer Nazlie Latefi said the results were “greatest decreases to date in overall illness severity using clinically validated measures and comparable study design.”

Oral pseudoephedrine decongestants marketed by Kenuve, Haleon and Opella, amongst others, are now only available with a doctor's prescription in France.

EMA's PRAC clarifies risk of high anion gap metabolic acidosis (HAGMA) in users of OTC paracetamol with new package leaflet and SmPC warnings.

The agency also will not expand the guidance categories that may be issued “for immediate implementation” without prior public comment, but more guidance documents could be issued in Q&A or bulleted formats, the agency said.

The incoming Trump Administration’s “Department Of Government Efficiency” has big plans for sweeping cuts to the federal bureaucracy and regulation. The US FDA likely will feel some effects, but could avoid the most damaging mandates.

Martin Makary prides himself on following the data, but some health policy experts said his positions sometimes stray from or distort the evidence, which could create trust issues.

The EU’s health nominee may not be as controversial as the recent US one, but the candidate being grilled has proved the least popular of the commissioner nominations with MEPs

Consumers in Denmark no longer need a prescription to buy opioid antagonist naloxone as the country looks to tackle the growing issue of overdose.

Proposed administrative order likely is first to prompt opposition from OTC industry or other stakeholders potentially delaying or deferring the agency’s expectation for moving its proposal to a deemed final order effective one year after it would be published.

Although FDA concluded OTC oral phenylephrine is ineffective as a nasal decongestant in doses up to highest studied level, federal preemption precludes challenges to agency’s regulation of labeling for phenylephrine and other Rx and OTC drugs, according to recent decision in New York federal court.

Perrigo is among the supporters of a campaign to get a clause of Germany's Medicines Advertising Act removed, which bans the advertising of the OTC morning after pill.