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Safer, better, faster.

 

Pharmaceutical regulation sets the scientific standards and framework for getting high quality, safe and effective medicines to patients. It is an essential component of the process that turns the spark of an idea into a licensed therapeutic that can transform the lives of patients across Europe.

Our functioning regulatory system is also a key factor in Europe’s competitiveness in the global race to attract life-science investment to the region, particularly in the context of intense competition from other global economies, notably the US and China.

 

Number of new chemical or biological entities 

Source: SCRIP – EFPIA calculations - link

Regulatory science is a field looking into developing new tools, standards and approaches to evaluate the efficacy, safety, quality and performance of vaccines and treatments, in order to facilitate a sound and transparent regulatory decision-making. It can be a fast-moving and exciting area, and is transforming the way new therapeutics are developed through advances in science, data analytics, the ability to collect real-world data and turn them into real-world evidence. 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.

The total number of Next-Generation Biotherapeutics (NGBs) – defined as cell, gene and nucleotide therapies – in the development pipeline went from 120 in 2015 to 269 by the end of 2018.

NGBs make around 10% of the total late-stage R&D pipeline and have more than doubled in number over the past three years as new pathways for disease treatment and cure.

Source: IQVIA, The Changing Landscape of Research and Development, April 2019, link

 

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 provides the clear time-points at which regulators, patients and industry come together to address different issues, with clear roles and responsibilities of every player. Working according to the rules set by the regulatory framework means working on a wide range of subjects such as having a scientific dialogue and getting advice in different phases of medicine’s development, until their marketing authorisation.

The framework also covers the provision of evidence that medicines are researched and manufactured in compliance with regulations (Good Laboratory/Clinical/Manufacturing Practices), and the continuous monitoring of medicines once they have entered the market in order to detect potential safety and quality issues. An important role the framework plays is around relaying information and informing the development and decision making across medicine’s lifecycle - including real-world data collected in patients’ Health Records or registries.

As part of the medicine’s licence, environmental and sustainable manufacturing issues need to be addressed as well, and compliance with the respective legislative requirements needs to be proven. Furthermore, there is always a need for a revision or an update to the marketing authorisation details at some point, such as routine continuous updates to the existing licence. New scientific information could also lead to an extension of application to be able to give the medicine to additional patients’ groups, such as children, pregnant women and elderly.

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.

 

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