In 1995 Amidon et al. published a biopharmaceutics classification system (BCS) that utilized a drug's solubility and permeability to judge the likely impact of in vitro drug product dissolution properties on in vivo absorption and bioavailability.1 Since that time, many regulatory agencies around the world have adopted guidances on use of BCS-based biowaivers. While the guidances are generally similar, they differ in ways that might affect which products qualify for a biowaiver. For products that are marketed globally, this means that otherwise unnecessary human bioequivalence studies will be performed as they are accepted in any market. These differences lead to significant reductions between the maximum (least restrictive guidance criteria) and minimum (most restrictive guidance criteria) number of possible biowaivers In October 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use began efforts to provide recommendations to harmonize guidances for BCS-based biowaivers.2 Solubility, permeability, dissolution, excipient, and product topics are to be addressed in these efforts. The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) is a technically-focused organization of pharmaceutical and biotechnology companies with a mission of advancing science and technology to augment the capability of member companies to develop transformational solutions that benefit patients, regulators and the broader R&D community. Its members have substantial expertise in all scientific domains associated with BCS-based waivers and drug product quality as well as considerable experience in the application of BCS-based biowaivers. The ICH process recognizes that harmonization is achieved through the development of guidelines via a process of scientific consensus with regulatory and industry experts working side-by-side. Thus, to facilitate these efforts and to encourage open and transparent discussion of other perspectives that may exist, IQ offers their perspective on a selected number of these and related topics. 1. Amidon GL, Lennernäs H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res. 1995;12(3):413-420. 2. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH Final endorsed Concept Paper M9: Biopharmaceutics Classification System-based Biowaivers. October 7, 2016. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M9/ICH_M9_Concept_paper-final_7Oct2016.pdf.