Industry Takes EU to Task Over Pharmacovigilance Fees
Europe’s main pharma industry bodies - EFPIA, EGA, EuropaBio, AESGP and EUCOPE - have issued a joint statement to express concern about “the increasing financial burden of regulatory costs incurred since the adoption of the pharmacovigilance package in 2010?.
Europe’s main pharma industry bodies - EFPIA, EGA, EuropaBio, AESGP and EUCOPE - have issued a joint statement to express concern about “the increasing financial burden of regulatory costs incurred since the adoption of the pharmacovigilance package in 2010″.
The EU’s procedural fees, such as for pharmacovigilance referrals, the industry argues, have been significantly increased in the last five years without open and transparent communication of calculations supporting this increase. The cost of pharmacovigilance activities should have been partly covered by community funding, their statement adds, as they are “part of the general mission of the EMA and of the National Competent Authorities to ensure public health.”
An overall legislative revision of the EMA fees regimes in the medicinal products sector is expected in the coming year. The industry is now calling for annual cost breakdowns and detailed information on performance indicators for the activities covered by the fees regime.
The statement concludes that industry “looks forward to establishing a dialogue with regulators and payers in order to ensure that the future system is firmly based on the principles of cost-effectiveness, fairness, proportionality and transparency.”
Addressing Disparities in Psoriasis Trials: Takeda's Strategies for Inclusivity in Clinical Research
April 14th 2025LaShell Robinson, Head of Global Feasibility and Trial Equity at Takeda, speaks about the company's strategies to engage patients in underrepresented populations in its phase III psoriasis trials.
Beyond the Prescription: Pharma's Role in Digital Health Conversations
April 1st 2025Join us for an insightful conversation with Jennifer Harakal, Head of Regulatory Affairs at Canopy Life Sciences, as we unpack the evolving intersection of social media and healthcare decisions. Discover how pharmaceutical companies can navigate regulatory challenges while meaningfully engaging with consumers in digital spaces. Jennifer shares expert strategies for responsible marketing, working with influencers, and creating educational content that bridges the gap between patients and healthcare providers. A must-listen for pharma marketers looking to build trust and compliance in today's social media landscape.
Pfizer, GSK Gain ACIP Recommendations for RSV and Meningococcal Vaccines
April 18th 2025The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to expand access to Pfizer’s respiratory syncytial virus vaccine Abrysvo for high-risk adults in their 50s and voted in favor of GSK’s meningococcal vaccine, Penmenvy, for streamlined adolescent protection.
