Michaela Merz


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PwC’s Pharma & Life Sciences Regulatory Radar


Increasing regulatory challenges

The pharmaceutical & life sciences industry, a long-standing, innovative and successful industry, needs to function in an increasingly challenging market environment. Regulation is one of the main reasons for this. In an increasingly interconnected world where more and more sophisticated pharmaceutical (e.g. genetically engineered, and biologicals, orphan drugs), Medtech as well as nutrition products are being developed, public scrutiny and ultimately legal frameworks are tightening. Governments and regulators are adopting more regulations in order to meet the requirements of technological advancement and changing social conditions (e.g EU GMP/GDP Annex 21, Annex 6 and 16 for clinical trials and the new Swiss “Arzneimittelverordnung”). Given the vast quantity of regulations, there is an inherent risk of missing out on critical topics or taking the required action too late. Therefore, the pharmaceutical & life sciences sector will have to be vigilant and adapt to the constantly changing regulatory landscape. Continue reading