This week marks the publication of the updated Variations Guidelines.
The new framework is designed to improve the efficiency of the regulatory system for human medicines – including those used in combination with medical devices. It is designed to accelerate patient access across the product lifecycle, while keeping pace with scientific and technological advances, accommodating the growing number of variation submissions.
By the end of 2025, EMA will publish additional procedural guidance to help companies prepare for these changes – something worth keeping an eye on LINK!