Category : Hta template
This aims to allow medicine developers to obtain feedback from regulators and health technology assessment HTA bodies on their evidence-generation plans to support decision-making on marketing authorisation and reimbursement of new medicines at the same time. These consultations can take place before or after the product is made available on the market. The objective is to help generate optimal and robust evidence that satisfies the needs of both regulators and HTA bodies. Interactions between medicines' developers, regulators and HTA bodies or other possible stakeholders to discuss the development plan means that evidence can be generated to meet the needs of respective decision-makers as efficiently as possible.