Moving Towards a Single Global Approval of Drugs: From Concept to Reality

Abstract

Access to high-quality pharmaceuticals is critical to achieving right to health. Despite advances in health-care technology, there are various hurdles to the availability of quality medicines in developing countries. Quality of medicines, and nationally regulated drug approval processes heavily influence drug prices. There are various obstacles to making high-quality medicines available worldwide. Efforts such as eCTD, the Drug Price Competition Act, USFDA's Generic Drug User Fee Amendment, emergency use authorizations, etc. are major endeavours aimed at simplifying and expediting the generic drug approval process. While these efforts are admirable, drug approval processes need to be harmonized to reduce costs, increase market competitiveness, and improve drug accessibility to the underprivileged. Significant differences between countries in application processes, prices, and study requirements, motivate pharma to focus on more profitable regions. Disparity in drug approvals also generate significant differences between developed and developing countries in quality and price of drug products. ICH reflection paper, in response to US FDA's recommendation for harmonizing generic drug approvals, is a significant step towards improving drug availability and access. At the same time, it is critical for the world to consider a single global system for drug approvals that can revolutionise the pharma industry by making even the most expensive drugs available to underprivileged regions.