Table 1

Types of studies with data points included in the review and definition

Study/report typeDefinition
Scientific reportsQuality controlSurveillance in which samples were collected to be analysed in routine postmarketing surveillance by MRA or a laboratory mandated by an MRA
Prevalence surveyStudy in which samples were collected within the pharmaceutical supply chain to assess their quality in order to describe the prevalence of circulating SF medicines
Equivalence studyStudy to assess the quality of different marketed brands of the same APIs, assuming that the results of the collected samples would represent the quality of the brand as a whole and not an estimate of the frequency of individual samples of different quality
Stability studyStudy in which quality tests are performed on medicines subjected to various storage conditions
Bioavailability studyStudy of the in vivo bioavailability, that is, testing for adequate body tissue concentration, including the rate and extent to which the drug reaches the body tissue compartment
Other reportsRecall/warning/alertRecall/warning/alert of products by manufacturers via MRA or by MRAs directly, or by WHO rapid alert
Case reportsPatients not responding to medicines or experiencing adverse drug reactions in which the quality of the medicine was suspected as the cause, also includes samples analysed for quality not included in a scientific study
SeizureConfiscations by police or MRA
  • API, active pharmaceutical ingredient; MRA, medicines regulatory agency; SF, substandard and falsified .