Abstract

REGULATORY REQUIREMENTS IN VARIOUS COUNTRIES: A REVIEW

P. Nandhini*, M. Malathi, K. Harsha Priya, Dr. P. Aparna, Dr. Y. A. Chowdary

ABSTRACT

Is to make a comprehensive detail of IND, NDA, ANDA in U.S and also to discuss about approval process in India corelate with their respective guidance document .Pharmaceutical regulations in various countries aim at assisting, controlling &ascertaining the making and marketing of any new drug or an abbreviated new drug into the market these regulations are also required for controlling pricing of a product, as this is a priority issue in some under developing countries. The regulations aim at releasing a safe and effective drug with minimum side effects into the market. Regulations are famed to facilitate is in export & import of pharmaceutical product in the global market. Guidance document helps in manufacturer to understand the more appropriate way of filing a IND /NDA/ANDA, approvals in India. To avoid any delays in approval process manufacturer to abide to these documents can be rest assured to get faster approvals. Aim of this review.

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