OECD GLP, U.S. EPA GLP & MAD agreements

After the implementation of the US FDA GLP regulations in 1979, the Organization for Economic Cooperation and Development (OECD) council came up with the decision on the principles on OECD GLP, OECD test guidelines and mutual acceptance of data (MAD) for global harmonization of the GLPs in 1981. Since then the OECD council has published consensus documents and advisory documents to be interpreted and applied as regulations by the participating OECD member countries. The OECD GLP, as recommended by the OECD council, has been currently implemented in 37 OECD member countries at the national level. Seven OECD non-member countries were given the status of full adherent to OECD GLPs. Benefits to member countries, who are signatory to OECD MAD agreement, included significant savings of time and money through avoidance of duplications of safety studies and reduced trade barriers. My presentation will cover the practical aspects of the OECD GLPs and MAD agreement for the benefit of US-based CROs and Sponsor companies who either submit studies to OECD member countries or outsource their studies to CROs that are in OECD member countries.