Overview of Complexities of Global CMC Regulatory Affairs

As the technologies within the biopharmaceutical industry evolve so does the global chemistry, manufacturing, and control (CMC) regulatory environment with ever-present complexity of gaining regulatory approvals around the world for new products for patients. From the earliest pharmaceutical laws in the 1900s to the inception of the International Council for Harmonization (ICH) to the transfer of regulatory oversight of well-characterized biologics from CBER (Center for Biologics Evaluation and Research) to CDER (Center for Drug Evaluation and Research), there has been a continuum of regulatory growth and oversight to ensure compliance and safety of all products globally. Every country and/or region has a separate health authority (HA) that oversees commercial licensure and clinical studies for all biopharmaceuticals. History, regional laws, regional cultures, and resources are many of the factors that influence the regulatory environment around the world, and all HAs must be engaged appropriately for successful global rollouts of biopharmaceuticals.