By Connie Leech
Adherence to regulatory standards is non-negotiable in the dynamic world of biotechnology, where innovation advances rapidly and patient safety is paramount. The latest regulation that Biotech companies operating in the European Union (EU) must now comply with is Annex 1 of the EU Good Manufacturing Practice (GMP) guidelines. Often hailed as the blueprint for pharmaceutical manufacturing, Annex 1 sets forth the requirements for the manufacture of sterile medicinal products. The FDA actively contributed to shaping this version of Annex 1, so the imminent adoption of this revised framework by the U.S. regulator seems all but inevitable.
Here, we will delve into the revised EU GMP Annex 1, exploring the changes it introduces and highlighting key considerations for biotech firms to maintain compliance. Additionally, we will examine compelling statistics that underscore the repercussions of non-compliance in this ever-evolving landscape. It is imperative that products falling under the biopharmaceutical umbrella, such as mAbs, gene therapies, and vaccines, adhere to Annex 1.