June 20, 2022
The Future of Regulations: EMA’s Perspective

The prime goal of a Health Authority (HA) is to promote and protect the interests of those it serves by amending and introducing new regulations. The European Medicines Regulatory Network (EMRN) is a network of competent authorities that work in sync to draft guidance documents that regulate medicines while upholding the standard of the medicinal products being authorized. The advent of technology has introduced sophisticated tools that may further support the currently existing framework. Accelerating forward with a motto of “Science, Medicines, and Health,” the European Medicines Agency (EMA) has published its strategic vision until 2025.

To stay updated with the industry trends, it is necessary for HAs to raise questions and work towards seeking solutions for the same. In its strategic plan for the industry, the EMA addresses topics of interest such as:

Utilizing the understanding of science and technology in drug development and monitoring

The ultimate public health objective is to guarantee that regulations enable the development of new medications and creative approaches, allowing patients’ needs to be met better with safer, more effective, and clinically acceptable treatments. This necessitates the network’s consideration of issues such as a shift to more patient-centered healthcare and precision or personalized treatment.

Collaborating with global HAs to achieve quality scientific evaluations

The EMA aims to give better evidence to policymakers and health technology assessors/payers to make informed Regulatory evaluations and judgments so that patients may get expedited access to valuable therapies while being protected against drugs whose benefits do not outweigh their hazards. The collaboration and exchange of such data across HAs can capture real-time evidence broadly and efficiently throughout the lifetime of a pharmaceutical, from preclinical development through clinical trials and real-world application.

Advocating initiatives with patient-centric access to medicines in association with health systems

Patients and healthcare providers should be at the focal point of Regulatory efforts, thereby enhancing access to medications as the key aim. The goal of public health is to guarantee that patients have timely access to cheap medications that fit their medical needs and that all the stakeholders in the healthcare system have access to adequate knowledge that they need to prescribe and utilize medicines correctly.

Addressing health emergencies and early preparedness for future pandemics

Post the pandemic, several proposals have been made in support of this aim. The EMA will continue to support worldwide efforts to react to public health challenges, including the development of novel antibacterial medicines and vaccines to combat antimicrobial resistance. It will also fund novel methods for vaccine research, approval, and monitoring, as well as activities to increase vaccination communication and promote public confidence.

Promoting innovation in research and development of Regulatory science

The EMA strives to create a revolutionary Regulatory science and innovation platform in collaboration with university research centers. The ultimate goal for public health is to keep Regulatory science on the cutting edge so that the competent authority can fulfill its core mandate of preserving human and animal health and making medicines more accessible to patients.

In conclusion, regulators strive to bridge the gap between the academic and professional trends in Regulatory science to invite research and innovation. To learn more about the roadmap to the EU market entry and decode the amended regulations, tune in to Regulatory Radio on your favorite streaming platform!