The regulatory approval of drug products can be time consuming and inefficient. Different regulatory requirements often result in laboratory work having to be repeated, with costs ultimately being passed to health systems and patients. The Brazilian Health Surveillance Agency (Anvisa) has been playing a leading role in regional harmonisation forums and is one of several regulatory agencies seeking to resolve differences in the regulation of drug products. “The Brazilian regulatory agency is taking a more open and scientific position for acceptance of innovation, especially for pharmaceutical changes in molecules that are already approved,” explains Gustavo Santos, a coordinator within the division of therapeutic equivalence at Anvisa. As well as standardising definitions of common technical requirements, the agency is exploring the use of computer simulation (or in silico) tools to avoid unnecessary in vivo studies and redesigning internal procedures to optimise regulatory activities.
“Harmonisation of quality standards that considers science-based approaches could bring more regulatory coherence,” says Dr Santos. “It could result in fewer unnecessary barriers to access available therapies.”
During this session, the benefits of harmonisation will be explored, highlighting the savings that can be gained from eliminating inefficiencies.
“[Harmonisation will] promote a common language for technical and scientific development in the pharmaceutical field, which could result in significant advances in agility and ease of innovation,” says Dr Santos. But there are challenges. “[We] need to consider different regional situations in order to define requirements. This may result in different approaches based on economics, politics or technological realities.”
Dr Santos is hopeful that harmonisation of quality standards will change the pharmaceutical landscape by promoting a more aligned environment for investments and therefore stimulating scientific development.
Join Dr Santos and colleagues from the US Food and Drug Administration and the European Federation of Pharmaceutical Industries and Associations at session B9 to hear about their experiences of harmonisation procedures.