Pharmaceutical Regulatory Affairs: Open Access

Mali DP

Publications

• Review Article
  Regulatory Requirements and Drug Approval Process in India, Europe and US
  Author(s): Sawant AM, Mali DP and Bhagwat DASawant AM, Mali DP and Bhagwat DA
  
  Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for Marketing Authorization Application (MAA) approval of new drugs. Every country has its own regulatory authority which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. Once a lead drug molecule has been discovered, nonclinical studies of a drug should be conducted to ensure efficacy and safety. Then, clinical trials can be performed, after an application is submitted to competent authority of the concerned country. The three phases of clinical trials are conducted as per the protocol. The competent authority reviews an application submitted to get approval for marketing the drug.. Read More»
  

  Abstract PDF