Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 09 December 2015 | By Michael Mezher
The newly reinstated head of the European Medicines Agency (EMA), Professor Guido Rasi, on Wednesday outlined his priorities for his new five-year term.
In his first press briefing since being reinstated as Executive Director of EMA in November, Rasi says he sees three major factors that will set the tone during his term.
First, Rasi says "our understanding of the human body and the underlying science [of medicine] has vastly grown" in recent years.
To meet this challenge, Rasi says that regulators "need new approaches and new expertise to evaluate treatment [and] need to find new ways to steer research and development towards unmet medical needs."
Rasi also said that EMA's commitment to publishing clinical data for approved products will help "researchers who will be able to use the data [and] companies who will be able to save time in development … by having information on what has worked or not in trials already carried out."
Additionally, Rasi emphasized patient involvement in the regulatory process, saying that patient values can help inform both clinical trial design and the benefit-risk assessment.
Second, Rasi says that ever-increasing globalization has brought increased complexity and new vulnerabilities to the medicines supply chain. According to Rasi, "up to 85% of medicines consumed in the European Union have had at least one step of production outside of Europe."
Rasi says that in the coming years, EMA will work to reinforce its role as a "global reference authority," and will help countries outside the EU build their regulatory capacity.
Third, Rasi points to several factors that threaten the sustainability of healthcare systems in the EU, saying "the aging population, growth in chronic diseases, higher public expectation [and] the rising cost of medicines," are chief concerns.
Rasi added that while "the pricing of medicines is outside [EMA's] remit, we feel we must contribute to finding solutions to ensure the sustainability of healthcare systems."
According to Rasi, EMA will work to support a "leaner, more efficient regulatory system," which in turn would create an expectation for lower drug prices and bring new treatments to patients faster.
Rasi highlighted two recent initiatives, the adaptive pathways pilot and PRIME scheme, which are exploring ways to speed access to new medicines, "without compromising on safety."
Under the adaptive pathways pilot, EMA is working with companies to support either staggered or conditional marketing authorization to get medicines to patients more quickly, then using real world data to support full authorization.
PRIME, on the other hand, will look accelerate the approval of medicines that meet an unmet need or offer significant advantages over existing options through early engagement and tailored scientific support.
Tags: Guido Rasi, PRIME, Adaptive Pathways, Transparency