The main focus of regulatory authorities is on product’s quality, safety and efficacy with their respective country. It does not only involve the process of regulating and monitoring the drugs product but also the process of manufacturing, distribution, and promotion of drug product. One of the foremost challenges or goals for regulatory is to ensure the pharmaceutical products are developed as per the regulatory requirement of that respective country.
All new or generic drug products must be approved, by the respective regulatory agency governing the respective market before a particular product can be introduce into the market. Every country has its own regulatory authority. This regulatory authority is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. In this review article we mentioned & thoroughly study about the rule & regulations regarding ANDA registration which are followed process in America Europe and India.
Keywords: ANDA, Registration, Generic, Clinical, NDA