Kamlesh Kumar Sharma

The budding regulatory professional who has just stepped in the new horizon of pharma field, may find starting and conducting clinical studies and getting relevant authorization or approval in the United Kingdom complicated and time-consuming process, which it is actually. But this article will help them giving an insight on what steps are followed to conduct clinical trial in general, how to apply for a clinical trial authorization in UK, what documents required in a nutshell and how to get clinical trial approval with less effort, and in more smooth and efficient manner. We all know that time for pharma field is equivalent to money, as pharma companies use to have a huge expenditure in research and development of a medicine and to recover that huge expenditure they would seek for regulatory approval as faster as they can manage so that they can market the drug, once the safety and efficacy data is established through clinical trials. And thus this article will aid to new regulatory professionals who are interested to involve in the regulatory activities pertaining to clinical trials in a highly regulated market like United Kingdom and thus with better understanding with regulatory process they can save the time of company and can go through this complex system successfully.

An orphan drug is a pharmaceutical agent that is used to treat a rare medical condition (viz., Huntington’s disease, myoclonus disease, Tourette syndrome etc.). They receive little attention from pharmaceutical companies as the small patient population could not justify the huge investment required for drug development. In the last 20 years, orphan drug act has been adopted in several countries around the world (USA, Japan, Australia, and the EU) and has successfully promoted R&D investments to develop new pharmaceutical products for the treatment of rare diseases, but it faces future challenges like returns on the huge R & D costs, funding sources and initiatives for development of orphan drugs.