Regulations, safety & supply
Safer, better, faster.
Our well-functioning regulatory system also plays a significant role in enhancing Europe's competitiveness in the global race of attracting investments in the life sciences sector. This is especially important given the fierce competition we face from other global economies, particularly the United States and China.
To remain competitive and to become a world leader in medical innovation, Europe must continue to evolve its regulatory system to stay at the cutting edge of regulatory science and policy.
Working together to deliver more for patients, in Europe and beyond
|
EFPIA and its members provide their practical experience and improvement suggestions on all phases of medicines development, manufacturing and regulatory aspects. All of EFPIA’s submissions to regulatory consultations are made available online and you can access them here. |
The European regulatory framework sets out when and how regulators, patients and industry work together, with clear roles and responsibilities for each. This includes scientific dialogue and advice at different stages of a medicine’s development, through to marketing authorisation.
The framework also requires evidence that medicines are researched and manufactured in compliance with Good Laboratory, Clinical and Manufacturing Practices. Once medicines enter the market, continuous monitoring helps detect potential safety and quality issues.
Sharing information is another important part of the framework. Evidence, including real-world data from patients’ health records and registries, helps inform development and decision-making throughout a medicine’s lifecycle
Environmental considerations and applicable requirements for sustainable manufacturing must also be addressed, with evidence of compliance with the relevant legislation
Furthermore, marketing authorisations need to be updated throughout a medicine’s lifecycle. These changes range from routine updates to applications to extend a medicine’s use to additional patient groups, such as children, pregnant women and older people, where supported by new scientific evidence.
Upon regulatory approval, there is a separate evaluation and a decision (Health Technology Assessment) on price, as well as negotiations of potential reimbursement conditions covered by national healthcare systems.
Looking beyond Europe
|
EFPIA and the European Commission/European Medicines Agency are also founding members of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. You can find more information on ICH via this link. |
Regulators across the world are facing a number of common challenges including greater interdependence, a rising workload and limited resources. There are clear advantages for patients, industry and healthcare systems and for international regulators to work together to achieve a more integrated approach to regulation.
Global regulatory convergence is a means of aligning regulatory requirements across the world via a process of gradual uptake of internationally recognised technical and procedural standards and principles, with the aim of improving healthcare. It does not necessarily mean that all laws and requirements are harmonised, but that greater regulatory cooperation is made possible. Such approaches cut the so called “regulatory red tape” and allow for faster access by patients to quality, safe and efficient vaccines and treatments all around the globe.
