After over a year of uncertainty the decision has now been taken to relocate the European Medicines Agency to Amsterdam. The result comes after a day of voting that was ultimately concluded through the luck of the draw between the two final cities, Amsterdam and Milan.
Johan Strömquist, CEO of NDA Group commented on the decision:
“Though there were many strong alternatives to host the Agency, we at NDA are pleased that the decision ultimately fell on Amsterdam where the greatest opportunity to retain Agency expertise was possible.”
Amsterdam was the top location identified when EMA staff expressed their preferences. This is particularly important for the continuity of the Agency’s work and the retention of expertise across the transition period and beyond.
Thomas Lönngren, Strategic Advisor at NDA Group and former Executive Director at the EMA commented:
“For me it’s been a year of frustration waiting for this decision. My heart is still with the Agency and their mission is of such incredible importance to all European citizens and the pharmaceutical industry. The decision on Monday took away the uncertainty and the agency can now plan for the future.”
Amsterdam offers excellent connectivity to all EU countries as well as the rest of the world and the Dutch government has provided a building that can be shaped to the Agency’s needs.
Frits Lekkerkerker, Clinical Advisor and Member of the NDA Advisory Board, also former Chair of the Dutch Medicines Evaluation Board commented:
“I’m proud that the EMA will relocate to Amsterdam. The MEB always supported EMA in its work on better medicines available for European patients. The EMA will be welcomed with open arms and I’m convinced all stakeholders will work together to guarantee a smooth transfer and continuation of the Agency’s activities.”
Though Amsterdam is an excellent choice for the EMA, moving an Agency of close to a thousand people in a 16 month time frame is still a monumental task. Assessment of the Agency’s Business Continuity Plan in light of the relocation decision points to a few areas where biotech and pharma companies might want to review their options.
The following areas are some of those identified as being at risk of disruption:
- Emerging regulatory science,
- Collaboration with HTAs,
- Development of new guidelines, and
- Timely provision of Scientific Advice.
These areas are of particular importance to companies working in emerging scientific fields or with novel technologies. Assessing how delays in any of these areas will affect the development programs, as well as identifying alternatives to formal Agency guidance, will be important for all companies working on novel science.
Johan Strömquist, CEO of NDA Group commented:
“At NDA we will continue to work closely with our clients to provide timely scientific advice, through strategic regulatory and development assessments. We are in a unique position to reflect the current opinions and practices of the EMA better than any other alternative. We therefore have a great responsibility to support both biopharma companies and the Agency in ensuring that the transition goes as smoothly as possible.”
NDA is an independent consulting group based in Germany, Sweden, Switzerland, United Kingdom and the USA. Its mission is to ensure that good medicines reach patients without unnecessary delay. It accomplishes this by providing the pharmaceutical industry with a comprehensive range of professional services within regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. NDA’s team comprises of more than 25% ex-regulators from major EU Agencies, and a specialist Advisory Board consisting of Europe’s leading regulatory and HTA experts. The NDA Advisory Board provides scientific advice to pharmaceutical companies supporting them in gaining fast and constructive assessment of applications from regulatory agencies and HTA bodies.
Over the past four years NDA contributed to the development of over 40% of the new medicinal products approved in the EU.