European regulatory perspectives for innovative therapies.
The current regulatory requirements offer accelerated assessment of innovative therapies in Europe. Future perspectives include the need for increased interaction between stakeholders in pharmaceutical development. Development of new, high quality, effective and safe medicines in Europe is the common goal of academia, pharmaceutical industry and regulatory authorities. To achieve this, it is important that regulatory requirements do not hinder innovation and vice versa, innovation cannot be allowed to proceed without concerns for public health. Interaction between stakeholders in pharmaceutical development is of the utmost importance. A dialogue has begun and in the future it will be the responsibility of all stakeholders to ensure continuous exchanges in an environment that is characterised by new scientific advances and global development programmes.
Ormarsdottir
S
S
Reginster
J Y
JY
Abadie
E
E
D050071:Bone Density Conservation Agents / Q000627:therapeutic use; D018849:Controlled Clinical Trials as Topic / Q000592:standards; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry; D005060:Europe; D005062:European Union; D006801:Humans; D007880:Legislation, Drug / Q000639:trends; D010024:Osteoporosis / Q000188:drug therapy; D013678:Technology, Pharmaceutical / Q000331:legislation & jurisprudence / Q000639:trends
D050071:Bone Density Conservation Agents