Regulatory Actions Impacting Biologics

In this audio clip originally published by by PharmTech. Three regulatory actions are converging to move biologics, gene therapy, and the ATMP platform forward quickly, say Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, technical, Parexel.

Link to the audio clip and article on Pharmaceutical Technology

Understanding Recent Regulatory Developments Affecting Biologics Manufacturers

Recent regulatory developments from the U.S. Pharmacopeia (USP), the European Medicines Agency (EMA), and the FDA are shaping how biologics manufacturers approach product development, regulatory submissions, and supply chain management.

In this Ask the Expert discussion, industry experts explore how these developments may affect biologics manufacturers, including the availability of new analytical methods, efforts to address critical medicine shortages, and opportunities to leverage previously published research in regulatory submissions.

The discussion highlights how USP methods can support chemistry, manufacturing, and controls (CMC) development, how the EU’s Critical Medicines Act addresses supply chain vulnerabilities, and how FDA draft guidance on genome-edited gene therapies may allow manufacturers to incorporate existing knowledge into their submissions.

The experts also emphasize the importance of supply chain resilience, localized manufacturing, and industry engagement with regulators through public comments. By understanding these evolving expectations, biologics manufacturers can better prepare for regulatory submissions, address supply chain challenges, and support the development and availability of critical therapies.

Read the full article and watch the Ask the Expert discussion:
Understanding Recent Regulatory Developments Affecting Biologics Manufacturers