Regulatory Affairs

Tagline: “When two mirror images offer different paths, how do regulators choose which one should become medicine?” Introduction The rise of regulatory consciousness around chiral drugs in the 1990s opened a crucial new question:If mirror-image molecules behave differently, how should the pharmaceutical industry -and regulators -decide which enantiomer to develop, approve, and market? This episode explores how regulatory agencies like the FDA, EMA, PMDA, CDSCO, and TGA crafted expectations for the development, approval, and control …

Episode 5: Choosing the Right Twin: Regulatory Expectations for Single Enantiomers Read More »

Tagline: “When scientific precision sharpened, so did regulatory vision -technology became the bridge between molecules and medicine.” Introduction The regulatory awakening around chiral drugs in the 1990s did not occur in isolation. It was powered, almost inevitably, by remarkable scientific and technological breakthroughs. Before sophisticated tools existed, distinguishing and isolating enantiomers was labor-intensive, error-prone, and prohibitively expensive. It was the advent of new chemical, analytical, and bioanalytical technologies that made the regulatory demands for stereochemical …

Episode 4: Technology as Catalyst: How Science Enabled the Regulatory Transformation Read More »

“Science may be universal, but regulation wears many faces. Let’s journey through the world of chiral drug approval across continents.” Introduction The 1990s witnessed a revolutionary shift in the regulatory treatment of chiral drugs, spurred by major agencies like the U.S. FDA and European Medicines Agency (EMA). However, the global regulatory landscape was -and still is -far from homogeneous. While scientific consensus around the importance of stereochemistry has largely been achieved, regulatory expectations, procedural details, …

Episode 3: Beyond Borders: Comparing How Global Agencies Regulate Chiral Drugs Read More »