Signal Management for US Sponsors of Generic Drugs
21 CFR 314.80 states all sponsors shall “promptly review all adverse drug experience information obtained or otherwise received from any source, foreign or domestic, including information derived from commercial marketing experience, post-marketing clinical investigations, post-marketing epidemiological/surveillance studies, reports in the scientific literature, and unpublished scientific papers.”
Pharmacovigilance (PV) requirements, as outlined by FDA and its corresponding regulatory authorities in the EU, US, and elsewhere, address the assessment of a product’s benefit-risk profile. The most important element of sponsor PV duties is continuous monitoring, recording, and assessment of new safety-relevant information and continuous notification of FDA, partners, or originators about any changes of a product’s benefit-risk ratio.
Among individual strategies to meet such requirements, Dr. Ebeling & Assoc. GmbH evolved the concept of Continuous Benefit- Risk Assessment (CoBRA®), which is well-established and especially appropriatefor generic drugs since a literature search for a generic API serves as the starting point.
Through CoBRA® we offer quality-controlled drug safety monitoring. The input for continuously reassessing the benefit-risk ratio derives from most relevant sources of safety information that are cost- and time-efficiently screened by our experts on a weekly basis. Validated signals will be evaluated for their impact on the API/drug benefit-risk ratio, which is the basis for recommendations about safety measures such as labeling updates, REMS updates, Clinical Expert Opinion (CEO) preparation or close monitoring.
We collect and assess safety information with respect to predefined reference information, for a company-specific product, or to an API, which allows us to provide the same coherent results to multiple sponsors, thereby reducing their individual workload. The advantage for sponsors of generics is striking since they are obliged to monitor the same safety-relevant data as originators and to keep the integrity of labels regarding the completeness of safety information.
Meet Legal Requirements and Implement Signal Detection and Continuous Benefit-Risk Assessment into your Business
- CoBRA® provides a quality-controlled process of drug safety monitoring according to internationally approved standards.
- Documented reconciliation with originator labeling and reporting to FDA – all requirements are met.
- CoBRA® results conform to PBRER/PSUR requirements and document sponsor activities related to state-of-the-art compliance with current post-marketing surveillance requirements. We use CoBRA® to compile monthly or quarterly modules for your PBRERs/PSURs.
- Make use of a proactive surveillance system and ensure a robust and traceable continuous safety evaluation.
Dr. Ebeling & Assoc. GmbH’s team of medical and scientific experts has the necessary experience in supporting your pharmacovigilance activities. Whether you are “small or big pharma”, we will tailor a time- and cost-effective, quality-controlled system consistent with your regulatory and pharmacovigilance-related needs.