Future of the Hungarian Drug Market : Role of the Hungarian Regulatory Authority

The National Institute of Pharmacy and Nutrition (NIPN) has a long tradition as the safeguard of patient safety and as an institution that is committed to ensure that Hungarian patients have access to good quality, safe and efficacious medicines. During the last few years responsibilities of the Institute has been broaden and now we are also a key player in the regulation of special food and medical devices. During the past two decades a transition can be seen in the role of medicines agencies. While in the past the role of regulators was mainly acting as a gatekeeper, nowadays we also need to act as enablers. And while ensuring regulatory compliance of new medicines is still a key activity, our role cannot be narrowed down to the review of documents and other authorization tasks. This is due to the enormous development in the field of biotechnology, precision medicine, the revolution in synthetic biology, just to name a few. On one hand regulators need to be prepared for these new scientific challenges, on the other hand we have to be ready to give the necessary regulatory support to those developers that are coming from various fields and have limited knowledge and experience in regulatory issues.