This week in London, Medicines for Europe gathers regulators and industry leaders to discuss future opportunities and challenges in the regulatory environment of the generic, biosimilar and value added medicines industry. Future changes in the regulatory landscape as a result of Brexit and the implementation of the Falsified Medicines Directive (FMD) will be discussed over the course of a two day conference in London. The opportunities for regulatory optimisation and international convergence will also be advanced as positive trends for the future.
The optimisation of regulatory operations, reflected in the HMA/EMA and CMDh 2020 workplans, are an important milestone for regulators and industry. In particular the ‘Regulatory Optimisation Group’ (ROG) offers a promising platform to find practical solutions for regulatory efficiency and operational excellence. Medicines for Europe will support this optimisation process for the benefit of patients and partners involved in or impacted by regulatory activities.
Marc-Alexander Mahl, Medicines for Europe President commented: “This conference provides an invaluable platform for stakeholders to adapt to the challenges posed by Brexit and FMD implementation while seizing opportunities to progress on regulatory optimisation and convergence for a more efficient system. Efficient regulatory systems will play a key role for patient access to medicines across Europe.”
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