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Time to modernise the eu pharmaceutical regulatory framework to deliver on access


30 Jan 2020


Health & Consumers
  • The new Commission is in pole position to adapt the pharmaceutical regulatory framework to the information technology era
  • The EU variations regulation is a prime candidate for digitalisation based on expert report.
  • Common standards and global development for generic medicines are needed to drive patient access in Europe and globally.
  • Solutions to tackle the root causes of shortages need to be agreed by industry and regulators to ensure security of supply

To maintain its leadership in pharmaceutical regulatory science, the EU should integrate digital tools in the regulatory process. Delivering results on digitalisation, updated variations procedures, streamlined development processes and medicines availability are clearly within the pharmaceutical mission of the recently appointed European Commission and are clearly aligned with the access objectives of the EMA-HMA regulatory science strategy.

Evidence compiled in a report further confirms the need to adapt the EU variations system to modern IT tools. Integrating effective IT systems and programmes into the EU variations legislation would enable a more efficient use regulator and industry resources and a stronger focus on what really matters to patients.

As part of a wider commitment to improve access to medicines in Europe and globally, the conference tackled the need for a framework for the global development of generic medicines. By moving to common science-driven standards with other highly regulated regions, industry will be able to streamline development and promote access, while avoiding scientifically unnecessary (and sometimes unethical duplication of) clinical studies.

Recognising the shared industry and regulatory objective of ensuring the supply of medicines, the conference focuses on tackling the root causes of medicines shortages as well as the interim measures needed to mitigate supply problems.

Christoph Stoller, Medicines for Europe President commented: “The political objective for health is clear:  Europe must have an adequate and sustainable supply of affordable medicines to meet public health needs. Our industry is a key partner to achieve these goals, currently supplying almost 70% of prescription medicines in Europe. Regulatory affairs can contribute significantly to these objectives by capitalising on digital technology and by making optimal use of the scientific resources of regulators and industry.”



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