On September 13, 2012, the State Food and Drug Administration (“SFDA”) published a Technical Guidance for the Periodic Safety Update Report for Marketed Drugs (the “PSUR Guidance”). This PSUR Guidance specifies how drug manufacturers must draft and submit a PSUR for their approved drugs as required by SFDA in its 2011 Rules on Adverse Drug Reaction Reporting and Monitoring (the “ADR Rules”).
Under the ADR Rules, foreign drug manufacturers are required to submit the PSURs annually for products that have been marketed in China for less than five years. After the initial five-year period, the PSURs shall be submitted every five years. Foreign companies are allowed to submit their global English PSURs, together with the Chinese translation of the whole text except the line listings and summary tabulations.
This PSUR Guidance largely follows the ICH E2C (R1) requirements, under which Drug manufacturers are expected to regularly evaluate and summarize safety profiles of their products and include at least the following information in a PSUR: basic product information, world-wide market authorization status, actions taken for safety reasons, changes to safety information, patient exposure, ADRs, safety studies, overall safety evaluation and conclusion. In particular, for imported drugs that have been approved for market in China for less than 5 years, manufacturers must analyze all ADRs associated with such products by both line listings and summary tabulations.
In addition, foreign drug manufacturers also need to explain in their PSUR (i) differences between the safety information of the drug insert sheet in China and that in other countries; (ii) differences between the indication, exposed population, dosage form and dose approved in China and those in other countries; and (3) why safety control measures are taken in other countries but the safety information approved in China is not changed accordingly.
While the PSUR Guidance imposes no mandatory requirements on manufacturers and allow manufacturers to prepare PSUR on a product-specific basis, going forward it will serve as the basis for SFDA to evaluate the quality of PSURs submitted by manufacturers and may have a de facto mandatory nature.