process validation for expedited approval drugs

White Paper:

Navigating the European Union’s (EU) Drug Device Combination Product Regulatory Changes

The European therapeutics market has been working to manage the upheaval caused by Brexit and is now working its way through yet another challenge: the medical devices regulation (MDR) changes that will soon go into effect and have significant impact on the regulation of combination products.

Regulation (EU) 2017/745 was enacted into law on May 25, 2017, replacing the EU’s Medical Device Directive (93/42EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). Per Article 117 of the new regulation, medicinal products with an integral medical device are subject to new requirements. Although a transition period was established, manufacturers and developers submitting drug–device combination (DDC) products for market approval on or after May 26, 2020, must comply with the new regulations.

With this deadline looming less than a year from now, what do these new regulations mean for combination drug manufacturers?

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