European legislators reached a preliminary political agreement on the revised EU medicines legislation, with changes affecting medicine availability, pharmacy preparations, antimicrobial stewardship and patient information provision.
Read at KNMP →Minister Hermans' "Werkagenda" contains concrete supply-chain agreements to prevent and resolve shortages faster. KNMP is positive, but chairman Miriam Stoks stresses the situation remains "code red" for patients and pharmacists.
Read at KNMP →Use of the MEB planning tool is now mandatory for marketing authorisation applications; slots are released every two months up to nine months ahead, and MEB fees increased per 1 January 2026.
Read at CBG-MEB →The reform simplifies EMA's structure to two scientific committees (CHMP and PRAC) and introduces regulatory sandboxes for innovative and personalised medicines — the biggest overhaul of EU medicines regulation in two decades.
Read at EMA →Industry federation EFPIA welcomed parts of the pharmaceutical package agreement but warns that Europe's competitiveness gap with the US and China remains unaddressed.
Read at EFPIA →June's committee meeting produced positive opinions including flu vaccine Aujemflu (50+), Parkinson's therapy Hopledo, once-weekly insulin Onswik and two biosimilars — new launch and positioning work ahead for these brands.
Read at EMA →On 2 July the EMA concluded that benefits no longer outweigh risks for Tavneos — a reminder that marketing authorisation, and the commercial story built on it, can be withdrawn.
Read at EMA →The June 2026 report maps how AI is used across the European medicines network — relevant context for agencies' expectations as pharma applies AI in evidence generation and communications.
Read at EMA →The agency has sent thousands of warning letters over six months — more than in the entire preceding decade — plus roughly 100 cease-and-desist letters, marking a dramatic shift in US promotional enforcement.
Read at FDA →Violations included implying sameness with approved products and obscuring product sourcing under the telehealth firm's own branding — compliance lessons for anyone marketing around the GLP-1 boom.
Read at FDA →The FDA found Anktiva promotions in a TV ad and podcast misleading for burying risk information relative to benefit claims — fair balance remains the enforcement flashpoint.
Read at FiercePharma →Six months post-launch, the "Carry On" TV spot positions the would-be blockbuster around fewer asthma attacks — a case study in timing DTC investment against a hostile ad-policy climate.
Read at FiercePharma →Amgen, BMS, AstraZeneca, Genentech, Novartis and Boehringer have all launched DTP services with self-pay discounts. The marketing question of 2026: where does classic DTC fit in a DTP world? (PharmaVoice, FiercePharma)
The FDA's enforcement surge and the EU pharma package entering into force in 2026 mean promotional review, claims substantiation and patient information will demand more marketing attention — and budget.
Pharma ad dollars continue shifting away from linear TV toward streaming and digital channels, accelerated by policy pressure on traditional DTC. (FiercePharma)