The processing of security data varies somewhat between the United States, the EU and other areas, but, in general, the obligation to expedite security reports on suspected serious adverse events to the relevant authorities is similar, at least from areas. The period during which reports are to be received begins when the report is received by the third-party/subcontracting provider, NOT when the report reaches the MAH. It is therefore in the interest of the MAH that the reports be forwarded to them (or to the service provider) in order to obtain them as quickly as possible, so that they can be processed properly and on time. In general, counterparties` pharmacovigilance obligations are limited to a limited number of clauses in framework contracts because of the comprehensiveness of the terms. It is the responsibility of the local representative of PHARMACOVIGILANCE (QPPV) to ensure that the pharmacovigilance obligations are clearly defined for both parties. In an organized setting, this responsibility is assigned to a dedicated POC role for the APV/SDEA. SDEAs can be requested for inspection in accordance with both fda and EU drug safety rules. Within the EU, the SDEA must contain at least, but not exclusively, the names and contact details of the qualified person competent in pharmacovigilance, any party responsible for monitoring the literature, collecting and filing the ICSR to the relevant authorities, the letter and filing of PSUR, the RMP, the detection and management of signals, the response to requests from the competent authorities who deal with complaints, etc. There are specific considerations to be made depending on the uniqueness of the business relationship that the partners could maintain.
To list a few, there could be a scenario whereby there is a “zero VPA” for the business relationship that does not justify sharing security information. In such cases, POC cannot ignore the full mention of the clause; on the contrary, it should be clearly justified in the trade agreement and/or stand-alone VPA clause (sometimes for other activities). Sometimes the original owner of the product has to take a step backwards because of his own restrictions or regulatory constraints in that particular area to get the MA in his own name. In such scenarios, the MAH would be in the name of the counterparty, which would act as the face of the product only when it comes to submitting legislation and all other activities are carried out by the former party. This situation is delicate and should not be confused with a scenario for regular service providers. Other specific considerations include merger/transfer and piggyback scenarios, which must be treated with the utmost care, taking into account all factors of influence. Outsourcing pharmacovigilance and allocating drug safety and regulatory activities can significantly reduce costs and workload for each marketing authorization holder (MAH). However, overall responsibility and monitoring of the pharmacovigilance system remains the responsibility of the MAH and the EU QPPV. In particular, it is the MAH`s responsibility to properly receive the process and expedite reports on adverse events and other safety reports if necessary.
Although all pharmacovigilance activities are outsourced, overall responsibility lies with the MAH. The legal and regulatory responsibility for any failure of a pharmacovigilance provider to properly comply with pharmacovigilance legislation rests with the MAH, not with the company to which pharmacovigilance has been outsourced. #PVA #SDEA #agreements #contracts #pharmacovigilance #drugsafety ability to work with databases (BALi, erooms) / with Sharepoint A Safety Data Exchange Agreement is a legal written contract that ensures that all safety data relating to a drug is promptly and reliably returned to the holder of the marketing authorization so that he can comply with his legal obligations.