Rushikesh B. Katkar1*, Dr. Rajkumar S. Bagali2, Amar S. Kulkarni3, Chandrashekhar V. Babar4, Pooja P. Patel5
1Vijayarao Naik College of Pharmacy, Kankavali, Maharashtra.
2Ashokrao Mane College of Pharmacy, Pethvadgaon-Kolhapur.
3,4,5Vijayarao Naik College of Pharmacy, Kankavali, Maharashtra.
This topic aims at reviewing the drug and drug product for filing and obtaining USFDA EMEA and TGA approval and its effective role to improve the standards which are laid by them. The respective Regulatory Agency approves the new/generic drug products that govern respective market before introduction of particular product into the market. The Regulatory Agency approves the entire new drug product to be safe and effective before marketing. USFDA is the Regulatory Agency which is responsible for the regulation of food and drug product in USA. EMEA is the Regulatory Agency which is responsible for the regulation of food and drug product in Europe. TGA is the Regulatory Agency which is responsible for the regulation of therapeutic goods in Australia. A dossier contains detail information about the drug substance and drug product and result of studies that are carried out in development process. For getting market authorization has to be submitted to the respective regulation bodies.CTD provides standardized structure. CTD makes filing easier globally. But there are differences in dossier submission requirements in these countries i.e. Module I is country specific and other regional guideline are also considered while compiling dossier application and Processing.