Safety Data Exchange Agreement Guidelines

These MA holders may have to establish different business relationships with other pharmaceutical companies or cros or other service providers in order to obtain the necessary authorization and market their manufacturing forms. These commercial relationships vary according to the requirements/consents/commitments/interests of both counterparties. These relationships are governed by master service agreements/trade agreements. One of the main reasons for non-compliance with pharmacovigilance is the inadequacy of the SDEA. Routine monitoring of data exchanged according to the SDEA is required. There should be a database for SDEAs for all products, partners, dates of agreements, drugs covered, bonds and documents exchanged, etc. It is a smart idea to develop one or more radiators that can be inserted into all contracts and agreements. They should be developed with the legal department and get the approval of the Business Development Group so that they are automatically added to all contracts. This is not unusual, as most contracts have several clauses that are “boiler plates” that cover other issues such as insurance, liability, etc. It is the primary responsibility of the marketing authorization holder to have an ADES to monitor and ensure that no security data falls because of any “gap”.

It is imperative that all data get through, and there is a system of acknowledgment and coordination of data sent and received. This applies to both clinical and post-marketing trial situations as well as specific programs such as patient assistance programs. Some companies only want MedWatch or CIOMS I forms for each case, others also source documents. 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. Depending on its relationships, the SDEA may include the attribution of responsibility for the EU QPPV, the PSUR letter, literary research, reporting to regulatory authorities, answering questions from regulators, processing product claims, signal recognition, hosting the security database and continuous assessment of profit-related risks. Where some or all of the pharmacovigilance activities are outsourced, including medical information, call centres, treatment of undesirable undesirables, the ADES must be complete and specify which parties are responsible for which activities, although the ultimate responsibility lies with the MAH. None of the above lists are exhaustive – the types of data and activities regulated by the ADES differ from company to company and from product to product. Since this agreement is binding on all partners, the legal department should review and approve the document. Typically, companies develop the SDEA model. 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.