An increasing number of biological medicines are being developed and used to treat a wide range of health conditions. Many challenges impede wider use of these technologies, such as complexities in the development, production, and regulatory framework. With exclusivity expiring, how can regulations assure quality, safety and efficacy, without becoming a technical barrier to competition? How can regulation accelerate access?
Carolina Gomez will present the regulation Colombia adopted in 2014, including the ‘fast-track’ approach used to accelerate access by reducing unnecessary regulatory requirements, as detailed in her 2016 article and will identify the main technical barriers in the international regulation (e.g. clinical comparability, differential nomenclature and restriction of substitution and interchangeability) explored in her forthcoming paper. Finally, she will discuss how Colombia's pioneering approach can inform ongoing international debates, including the evolution of WHO guidance on biologics regulation.
Carolina Gomez is advisor for the General Directorate, INVIMA - Instituto Nacional de Vigilancia de Medicamentos y Alimentos (National Institute of Food and Drug Monitoring), Colombia
Barreras técnicas innecesarias a la competencia y la inequidad en el acceso: el caso de los medicamentos biotecnológicos (forthcoming, bit.ly/CVCGbiosimilars)
The debate on regulating biotechnology drugs: Colombia in the international context (2016, http://iris.paho.org/xmlui/handle/123)
We hope you will be able to join us for this informative presentation. After registering, you will receive a confirmation e-mail with instructions to join the webinar.
This event is part of the inaugural webinar series of the Knowledge Network for Innovation and Access to Medicines, a project of the Global Health Centre at the Graduate Institute of Geneva. Suggestions for speakers and topics for future webinars are welcome at email@example.com.