Customer Requirement: A pharmaceutical company specializing in generic products, based in Saudi Arabia, required a customized additional risk minimization measure (aRMM) for its generic version of Pomaliomide capsules. This was a requirement of the regulatory agency, the Saudi Food and Drug Authority, in order to maintain safety and regulatory compliance.
Problem Statement: The National Pharmacovigilance Center (NPC) of the SFDA had requested the pharmaceutical company for the implementation of i-SECURE Risk Management Program Folder for the generic version of its product, Pomalidomide capsules. However, the reference material for the program was not available making it difficult to develop the aRMM. This material could also not be obtained from the SFDA despite sending a formal request.
Key Objective: To develop the aRMM to support regulatory & safety compliance requirements of the SFDA.
DDReg Solutions & Processes Adopted: The PV and safety writing team worked in close collaboration to develop the entire pregnancy prevention program (PPP) of pomalidomide based on the precedented PPPs which had been approved in the past by the SFDA. These included Pomalidomide Risk Management Program- At A Glance, and forms for prescriber registration, pharmacy registration, dispense authorization, treatment initiation, prescription authorization, patient brochure, pregnancy capture, and adverse event reporting.
The SFDA required certain documents such as the treatment initiation and patient brochure to be in English and Arabic language. For this, the team worked with its translation vendor to meticulously review and ensure there was no miscommunication or misleading information.
Business Impact: The DDReg team was successful in developing the tailored PPP which met the NPC’s requirement for its “additional risk minimization measure” for pomalidomide. This led to the successful registration of the product for the client. The client came back to DDReg for more support in pharmacovigilance and safety compliance for its products, leading to a long lasting business relationship.