Author(s): Abid Fida Masih
Biowaiver on the basis of BCS is an important tool for pharmaceutical manufacturers and regulators to show equivalence of generic drugs to innovator or reference products. Various regulatory authorities such as USFDA, WHO and EMA put forward guidelines to practice this approach. However, these guidelines were differing in many ways to each other which created difficulties for manufacturers and regulators to follow different guidelines for different regions. To answer this question efforts have been made by different authorities to harmonize BCS based biowaiver on global basis. Recently USFDA has revised guideline to align with WHO and EMA with respect BCS based biowaiver request. Similarly, ICH also planned to publish a harmonize guidelines for biowaiver based on BCS to take advantage of harmonization for bioequivalence and save humans and financial resources by following different guidelines for BCS based biowaiver request. As a result, a harmonized approach for BCS based biowaiver is evolved which will be beneficial to both pharmaceutical manufacturers and pharmaceutical regulators globally and ease the registration process for drugs in different countries.