OBJECTIVE To investigate FDA issued guidance on Bioequivalence Recommendations for Specific Products related to transdermal patches, which provide reference and assistance for the consistent evaluation of the quality and efficacy of generic drugs in China. METHODS According to the partial transdermal patch catalog released by FDA in Apr. 2018, combined with Bioequivalence Recommendations for Specific Products related to transdermal patches for anal. of recommended Studies, including study designs and schemes, selection, inclusion and exclusion criteria of bioequivalence subjects, strength, selection of reference products, analytics to measure, waiver request of in vivo testing, etc. RESULTS Different from conventional dosage form of chem. drugs, FDA Bioequivalence Recommendations for Specific Products stipulates that transdermal patch bioequivalence studies of generic drugs should be carried out, in addition to bioequivalence study with pharmacokinetic endpoints, the applicant should carry out adhesion study, skin irritation and sensitization study, resp. following FDA′s current thinking in the guidance Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs, guidance Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs, which provides detailed provisions on the bioequivalence evaluation of specific generics of transdermal patch from various aspects, and plays an important role in promoting the development of generic drugs in China. CONCLUSION Studying and FDA issued analyzing Bioequivalence Recommendations for Specific Products related to transdermal patches by would be conducive to understanding the bioequivalence standards and has certain guidance and reference significance to the ongoing evaluation of the quality and efficacy of generic drugs in China, since NMPA has not released similar guidance on transdermal patches.