Regulatory Efficiency

Many aspects of the innovative biotechnology supply chain differ from conventional pharmaceuticals and require close proximity to patients, highly specialised manufacturing, and physicians and hospitals to administer highly specialised care.

The intricacies of biotechnology-derived medicines for human use should be better reflected in the European regulatory framework. The EU should lead in implementing an agile regulatory system which allows for adaptable and accelerated regulatory assessments to fulfil unmet medical needs and emerging patient needs. It should ensure quick patient access to safe and effective treatments.

Through its Regulatory Policy WG, EuropaBio advocates the development of a progressive regulatory framework for efficient uptake of new healthcare biotechnologies in the EU.

EuropaBio seeks to actively engage in the implementation of the European Health Union, the EU Pharmaceutical Strategy, as well as in the EMA and HMA regulatory strategies with a view to support speed, innovation and EU competitiveness.

The COVID-19 pandemic has evolved the role of regulators at national and EU level and presented numerous lessons and challenges on which the global regulatory network must reflect on to guarantee long-term preparedness for future trends in health and science. It also highlighted the need for better alignment across the EU medicine agencies network. .