Pharmacovigilance Agreements: Negotiating Safety Data Exchange Timelines: To Agree to Disagree? That is the Question.

Pharmaceutical companies often enter into contractual arrangements with other companies to advance the development or expand patient access of licensed medicines. These partnerships include specific agreements detailing the exchange of safety-related data between the companies. Such agreements are used to fulfil regulatory reporting obligations, thereby ensuring timely awareness of potential safety considerations and formal maintenance of clinical trial applications and marketing authorisations.