The Association of the European Self-Care Industry gives EU regulators a to-do list of targeted reforms to save the Medical Devices Regulation from the scrapheap.
After almost seven years of implementing the EU Medical Devices Regulation, it has become apparent that its objectives have not been achieved, argues the Association of the European Self-Care Industry, AESGP.
“The current regulatory framework under the MDR is characterized by unpredictability, opacity, and resource-intensive processes, posing significant challenges for businesses,...
The European OTC market grew at double the rate of the global market in the last twelve months, according to IQVIA Consumer Health, driven by a long-term trend for prevention. Consultancy Simon Kucher identifies a desire to live a longer, healthier life as the primary concern behind this trend.
Limited capacity and a two-to-three year timescale for reformulation could mean that many VMS supplements disappear from the market, warns EPPA partner Alexandra Bocquillion, speaking at the AESGP Annual Meeting in Warsaw, Poland.
The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”
If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos
