S. Sandhya*1, K. Sunil Kumar2
1Department of Pharmaceutics – Drug regulatory affairs, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.
2Associate Professor, Department of Pharmaceutics – Drug regulatory affairs, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.
A b s t r a c t
Development of new drug is a complex, time-consuming, and expensive process. The time taken from discovery of a new drug to its reaching the clinic is approximately 12 years, involving more than 1 billion US$ of investments in today’s context. Essentially, the new drug discovery involves the identification of new chemical entities (NCEs), having the required characteristic of drug ability and medicinal chemistry. The study aims to evaluate the emergency drug approval system in China, USA, and Australia and India under public health emergencies. China has been the second largest single-country pharmaceutical market in the world for many years. However, over the years, several hurdles in China’s drug regulatory system and practice had significantly impeded drug development activities, new drug review, and approval in China. These included the overly strict requirements for clinical trial approval, lengthy regulatory review time, lack of clearly defined sponsor-agency communication channels, and the shortage of trained reviewers, to name a few. These factors had contributed to the large backlog of new drug applications and delayed access to innovative medicines and treatments. The increasing number of API manufacturing sites in China and other countries suggests that the United States’ reliance on Chinese and other foreign sources of API is growing. FDA has been working diligently in collaboration with industry and other federal agencies to ensure our reliance of foreign manufacturing does not pose a national security risk.
Keywords: New drug, China, USA, and Australia, New drug applications. Drug approval, FDA.