FDA’s Office of Pharmaceutical Quality (OPQ) has published a Guidance for Industry on the Regulatory Classification of Pharmaceutical Co-Crystals.
This guidance provides applicants planning to submit new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data that applicants should submit to support the appropriate classification of a co-crystal as well as the regulatory implications of the classification. This draft guidance revises the guidance for industry titled "Regulatory Classification of Pharmaceutical Co-Crystals" issued in April 2013.
Following finalization of the guidance on co-crystals in 2013, FDA learned that industry had concerns about the regulatory implications of the guidance. In a commercial setting, co-crystals are typically manufactured in drug substance facilities. However, when classified as a drug product intermediate, additional current good manufacturing practice requirements (CGMPs) apply to co-crystals. As a result of this classification, the guidance was not conducive to the development of co-crystals by industry. FDA reconsidered the appropriate classification of co-crystal solid state forms, the data that should be submitted to support the classification, and the regulatory implications of such a classification. This revised guidance includes a new approach to classification of co-crystals that are submitted in NDAs and ANDAs. Once this new draft guidance is final, it will replace the final guidance from 2013. FDA looks forward to continuing its work with industry and other stakeholders to ensure that the guidance achieves its objective of facilitating the development of new drug products while ensuring their quality.