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Efficient use of pharmacovigilance data essential for patient safety


Health & Consumers
  • Pharmacovigilance ensures patient access to safe medicines.
  • Industry is keen to optimize EMA pharmacovigilance processes to focus regulatory and industry resources on the most important issues for patients.

National authorities, regulators, industry leaders, and stakeholders gathered in London to discuss the role of pharmacovigilance in ensuring patient safety and access to safe medicines at the 12th Medicines for Europe Pharmacovigilance Conference.

As we move into an increasingly patient-centred future, simplification and improved communication should be at the heart of our pharmacovigilance strategy.
Digital technologies offer the promise of more pharmacovigilance data from different sources provided we can improve the capacity of the EMA pharmacovigilance system to better filter essential and non-essential information sent to companies for review. The EMA-industry dialogue should step up its efforts to streamline the functioning of the system.
Our industry also applauds the introduction of patient hearings which provide patients with a platform to share their views and contribute to better pharmacovigilance. This patient voice combined with targeted data will improve communication between industry, regulators, healthcare providers and patients in the future.
Adrian van den Hoven, Medicines for Europe Director General commented: “Efficient pharmacovigilance is paramount for the safe use of medicines. Industry and regulators have a shared responsibility to ensure that this system remains effective and efficient. We commend the regulatory community on the close cooperation to achieve results for patients who rely on medicines. We need to accelerate the use of structured data to streamline and focus pharmacovigilance systems on patient needs. Patient and healthcare practitioners are welcome contributors to this process.”
About Medicines for Europe
Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe, and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at and on Twitter @medicinesforEU.