Global Regulatory Landscape

In this chapter, the authors review the primary global regulatory authorities representing the economies that drive the industry, describing their current organizational structure and procedural expectations. The reference point for these descriptions and differences in structure or procedure will be the US Food and Drug Administration, the oldest and largest regulatory organization, which is still viewed as the standard-bearer for regulatory science. Other organizations, particularly those that govern the largest populations, are discussed as well, and the authors also review how the collective process works for both drugs and vaccines. The organizations include European Medicines Agency, Pharmaceutical and Medical Device Agency, and National Medical Products Administration. Finally, the authors describe efforts to harmonize regulatory science and make it easier for drug and vaccine developers to coordinate regulatory filings and obtain market access globally.