The Key to Successful Drug Approval: An Effective Regulatory Strategy

Abstract: Why is an effective regulatory strategy important?

Let’s face it, drug development is a very important yet costly and high risk activity. Drug development times have increased enormously over the past decades, and the cost of bringing a drug to market has more than doubled in the past ten years. Today it takes far more than a decade at a cost in excess of $1 billion to bring a new drug from discovery to the market. Moreover, the pharmaceutical industry is one of the most regulated industries in the world. Patients benefit every day from the innovative drugs discovered, developed and produced by the pharmaceutical industry. Drugs have significantly contributed to public health as medical discoveries have made it possible to diagnose, prevent or treat many diseases. However, it seems the more we learn from science about drugs and their mode of action, the more new questions arise, resulting in increasing regulatory requirements that need to be fulfilled prior to market access. Despite improvements over time, up to 20 % of products still fail during the approval phase. This is a remarkable proportion considering the majority of development costs have already been spent at this advanced stage of development. Therefore it is key to have an effective regulatory strategy in place as soon as you start your drug development program. A well thought out regulatory strategy is an important tool to increase the success rate at the time of approval. In the following you will learn how to set up an effective regulatory strategy and which tools and measures are available to support your strategy.