New drug development process: Regulatory perspective

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Sanjay Reddy Akula and Jyothi Edla

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

New drug discovery is the process of identifying compounds that have the potential to become useful new therapies. The potential must be sufficient to justify further research and development. A crucial step in the drug development process is the submission of nonclinical and clinical data and information in a New Drug Application (NDA) to the food and drug administration (FDA) by the sponsor for seeking marketing authorization. A typical new molecular entity (NME) has most likely been studied pre clinically and has been in clinical trials. Stages in new drug development is Synthesis and isolation of compound 1-2 years, pre clinical studies (screening tests, tests on isolated organs and bacterial cultures, tests on animal models of human studies, general observational tests, confirmatory tests and analogous activity, mechanism of action, systemic pharmacology, quantitative tests, pharmacokinetics and toxicity tests) 2-4 years, Scrutiny and grant of permission for clinical trials 3-6 months, Pharmaceutical formulation and standardization of the compound 0.5-1 year, Clinical studies 3-10 years and grant of marketing permission 0.5-2years.The average cost of bringing an NME to market is nearly between 501 and 805 million dollars. The International Conference on Harmonisation (ICH) Guidelines is available providing a common format for new drug and biological regulatory submissions. The drug development process, including regulatory aspects can be in three areas. First one is providing a greater understanding of human health at molecular level. Second one is improve the safety of medicines. Third one is optimizing drug doses and dosing schedules. The drug approval process is divided in to an Investigational New Drug (IND) Application Process; New Drug Approval, and the post approval activities. The process of new drug evalution to determine the risk or benefit is affected by many conflicting factors. A detailed study of all the aspects of drug related studies and their procedures of clinical trials are evaluated before the approval. As long as an approved drug remains in the market, all aspects related to its safety are under constant scrutiny by the FDA.