Safety Data Exchange Agreement (SDEA)

Need of Safety Data Exchange Agreement (SDEA)

In the Pharmaceutical industry, MAHs will always have business partners who can support them in various ways such as manufacturer, distributor, license partner, co marketer, batch releaser etc. Depending on the type of business partner that is involved in the marketing phase of the medicine, MAH’s business partner name / contact details could be made available to the public through the Summary of Product Characteristics (SmPC), package leaflet, primary / secondary product packaging labelling, local country specific website etc. MAHs business partner would get drug safety information from patients / pharmacist / physician etc., and such reported details must be provided to MAH in a timely manner. Furthermore, MAH can take appropriate actions according to their procedures and comply with regulatory requirements as applicable.

Need of Exchange for Drug Safety Information between Different Business Partners

To ensure timely exchange of drug safety information between MAH and their business partner (parties), it is necessary to have signed contracts between the parties (for example, Distributor, Licensing Partner, Co-marketing, Batch Releaser, Manufacturer etc.). This is necessary to comply with the legal requirements of EU, UK, and other regulatory bodies.

SDEA/PhV Agreement describes business relationship of both parties, safety data exchange process and responsibilities along with agreed timelines, reporting of safety data to authorities, reconciling the exchanged safety information, support for audit and inspections, details of products under scope, etc.

SDEA/PhV Agreement helps to ensure that collected safety information are processed and exchanged with business partner within agreed timelines and thereby one business partner supports second business partner to meet regulators requirement of safety information submission (ICSR).

Additionally, SDEA/PhV Agreement scope can be extended for drug's additional risk minimisation material distribution, periodic report submission, conduct of local literature search, local responsible person for pharmacovigilance (LRPV), etc. based on business partner's need and agreement.

Our Solution for Complete SDEA Activity

AllyWorth supports for your SDEA/PhV agreement requirements across Europe, US, ROW countries. Our team shall be involved in preparation of SDEA/PhV agreement drafting, negotiation of roles/responsibilities terms with your business partner and finalising the agreement. The roles/responsibilities terms negotiation with partner shall be managed by our skilled and experienced professionals, which will save MAH’s time.

Additionally, AllyWorth also supports to get SDEA/PhV Agreement compliance in terms of timely case exchange, periodic reconciliation, and periodic review and update SDEA/PhV agreement or its annexes (role/responsibility, product list, etc.).