Discussions on the Revision of the General Pharmaceutical Legislation (GPL) primarily focus on the incentive frameworks, which are important contributors to innovation. Crucially, the GPL also governs a host of other elements related to drug discovery, regulation and approval which also play an important role in governing the EU’s competitiveness and sometimes does not receive the deserved attention. One key example is the approval timelines for novel therapies.
The European Medicines Agency (EMA) undertakes a comprehensive evaluation process for marketing authorisation applications, typically spanning up to 210 days, excluding periods when the ‘clock’ is paused for applicants to provide additional information (see here).
Current proposals under the Revision of the GPL reduce this timeframe to 180 days. Such a reduction could significantly enhance patient access to innovative treatments, bolster investment in pharmaceutical research, and make the EU’s position in the global healthcare landscape more competitive.
Accelerating Patient Access to Medicines
A shortened approval process directly benefits patients by expediting access to new and potentially life-saving therapies. Delays in the availability of medicines can have profound implications, particularly for individuals with conditions lacking effective treatments. By reducing the evaluation period from 210 to 180 days, the EMA can facilitate earlier patient access to essential medications, thereby improving health outcomes across the EU.
Implications for Future Innovation
Maintaining a protracted approval timeline may inadvertently convey a discouraging message to innovators and pharmaceutical companies. In an era where medical research is advancing rapidly, a sluggish regulatory process could be perceived as a barrier to innovation. This perception might deter companies from investing in the development of novel therapies within the EU, opting instead for regions with more streamlined regulatory pathways. Consequently, the EU risks lagging in the introduction of cutting-edge treatments, which could adversely affect patient care and the region’s biomedical research reputation.
The Impact of ‘Clock Stops’ on Approval Timelines
It is important to think at the context of a 30-day reduction, and the reality of the medicines approval timeline which already extends far beyond the current 210-day approval process. In this context, 210-days does not account for ‘clock stops’, periods during which the EMA pauses its evaluation to await additional data or clarifications from applicants. These interruptions can prolong the total time to approval, sometimes significantly. By adopting a 180-day timeframe, with a concerted effort to minimise clock stops through enhanced pre-submission guidance , clearer communication channels and commitment from sponsors to deliver the necessary information, the EMA can reduce overall approval times. This efficiency will ultimately benefit patients while not compromising on the safety and quality standards EMA stands for.
Stimulating Investment and Skill Development within the European Medicines Regulatory Network (EMRN)
A commitment to a reduced approval timeline serves as a catalyst for increased investment in the EU’s pharmaceutical sector. Companies are more likely to invest in research and development when they can anticipate a predictable and efficient regulatory process. Moreover, this commitment necessitates the upskilling of personnel within the European Medicines Regulatory Network (EMRN). Enhancing the capabilities of regulatory professionals ensures that they are adept at evaluating complex, innovative therapies within shortened timeframes, thereby maintaining the high standards of safety and efficacy that the EMA upholds.
Conclusion
Reducing the EMA’s marketing authorisation evaluation period from 210 to 180 days presents a multifaceted opportunity to improve patient access to medicines, encourage pharmaceutical innovation, and attract investment to the EU increasing overall competitiveness. Fostering skill development within the EMRN, the EU can reinforce its commitment to public health and solidify its standing as a leader in delivering safe and efficacious medical innovation.
Read EUCOPE’s previous position paper on Modernising the Centralised Procedure here .
EUCOPE’s blog articles are available here.
January 30, 2025
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