Over the decades, advancements in treatment procedures have brought about necessary amendments to the Regulatory framework. From Active Pharmaceutical Ingredient (API) identification to its placement on the patient’s side table, the core of innovating novel treatment protocols revolves around three (03) fundamental characteristics, including safety, effectiveness, and timely availability to the patient population. While patients explore the luxury of effective treatment, another segment of the population with unmet medical needs suffers at large. The European Medicines Agency (EMA) has introduced expedited routes like the PRIME - PRIority MEdicine, and the Innovative Licensing and Access Pathway (ILAP) as tools to promise accelerated approvals of novel medications. To monitor the quality of the novel therapy, the quality testing of drug substances plays a major role in the drug development lifecycle. Module-1 (regional administrative information), Module-2 (quality - overall summary), and Module 3 (quality) of the dossier include information upholding the optimum quality standard of a drug product.
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Guidance on Procedural Aspect for the consultation of Companion Diagnostics (CDx)
Quality by Design QbD- An Enhanced Route for Drug Development
