![]() ![]() When determining which category a programme falls into, MAHs should consider the following: AE reports should be classified as spontaneous and have implied causality.Programmes without active solicitation of information relating to the use of a medicinal product but may have incidental reporting that occurs in the margins of the programme:.AE reports should be classified as solicited or spontaneous depending on the programme structure.Programmes without active solicitation of information relating to the use of a medicinal product but with established mechanisms for reporting AEs:.AE reports should be classified as solicited and should undergo a causality assessment.Programmes with organised data collection that include active solicitation of information relating to the use of a medicinal product:.Programmes termed as ‘PSPs’ could be categorised as follows: Categorising safety data collection from PSPs for compliant safety reporting There is a risk that safety reports received spontaneously via a programme not based on organised data collection may not be correctly reported as adverse drug reactions. Under the EU guidelines, study (solicited) adverse events (AE) must be assessed by the company for possible relatedness to determine reporting requirements. Reports of suspected adverse reactions derived from organised data collection systems, including patient support programmes (as per the EU definition), are solicited reports. ![]() In practice, some of the programmes that are internally termed ‘PSPs’ by an MAH might not actually meet the definition above. Examples are post-authorisation patient support and disease management programmes, surveys of patients and healthcare professionals, information gathering on patient compliance, or compensation/re-imbursement schemes.” The following definition of a PSP is included in GVP Module VI (Rev 2), section VI.C.2.2.11: “A patient support programme is an organised system where a marketing authorisation holder receives and collects information relating to the use of its medicinal products. Many marketing authorisation holders (MAHs) sponsor and run a wide variety of programmes that are often internally termed a ‘patient support programme’ (PSP) and we are often asked by industry about the expectations for the collection of safety data from these programmes. ![]()
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