Rx-to-OTC switch and post-marketing safety are two key stages in the life cycle of non-prescription medicines where real-world evidence (RWE) has the potential to benefit regulatory decision making, according to a review article from the Association of the European Self-Care Industry, AESGP.
Real-World Evidence Can Play Important Role In OTC Regulation – AESGP Study
A published article from AESGP argues for the increased acceptability, application and use of real-world evidence in the OTC sector where it “may present a more intuitive or efficient way of generating data” compared to randomized controlled trials.
More from Europe
• By
Two AESGP papers reviewing the evidence for AMR risk associated with a range of OTC antifungals and antivirals conclude there is litte to no risk associated with the responsible self-care use of such medicines.
• By
HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.
• By
“Overall, no unexpected/new data or findings” were presented to Germany's Expert Committee for Prescription in the most recent Rx-to-OTC switch application for sildenafil (25mg and 50mg), according to medicines regulator BfArM, resulting in a third rejection in three years.
• By
“Protecting the environment is a shared responsibility. It is unfair to expect only two sectors to fund wastewater treatment modernization and operation,” argues AESGP director general Jurate Švarcaite.
More from Geography
• By
“Protecting the environment is a shared responsibility. It is unfair to expect only two sectors to fund wastewater treatment modernization and operation,” argues AESGP director general Jurate Švarcaite.
• By
TikTok dietary supplement sales in Thailand grew by an astonishing 635% in 2024, while sales via Vietnam's and Malaysia's traditional e-commerce platforms increased by a still impressive 73% and 83% respectively.
• By
Like many European firms, Stada Arzneimittel's 2024 earnings were held back by a soft cough, cold and flu season. However, key launches in its home market Germany and in the Middle East offset this impact and led to 3% organic growth for Stada's Consumer Healthcare business.