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Tag Archives: Common Technical Document

Process Involved for Registration of Generic Medicines and Format of Drug Dossiers in Australia

Rajkiran Kolakota1 & K.V.S.L. Kavya*2 1-2Department of Pharmaceutical Regulatory Affairs, Sri Sivani college of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, AP. A  B  S  T  R A C T Therapeutic Goods Administration (TGA) guidelines will assist sponsors to prepare applications to register new prescription or other high risk medicines for human use in Australia, or to vary existing medicine registrations. The ... Read More »

Process Involved for Registration of Generic Medicines and Format of Drug Dossiers in Australia

Rajkiran Kolakota1 & K.V.S.L. Kavya*2 1-2Department of Pharmaceutical Regulatory Affairs, Sri Sivani college of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, AP. A  B  S  T  R A C T Therapeutic Goods Administration (TGA) guidelines will assist sponsors to prepare applications to register new prescription or other high risk medicines for human use in Australia, or to vary existing medicine registrations. The ... Read More »

Regulatory Approval Procedures in USA

J. Praveen Kumar1, Rajendran Sai Divya2, Dr. M. Kishore Babu3, Dr. P.V. Murali Krishna4 1Associate Professor, Krishna Teja Pharmacy College, Tirupati, Andhra Pradesh. 2Krishna Teja Pharmacy College, Tirupati, Andhra Pradesh. 3Principal, Krishna Teja Pharmacy College, Tirupati, Andhra Pradesh. 4Associate professor, MNR College of Pharmacy, Sangareddy, Hyderabad, Telangana. A B S T R A C T The Food and Drug Administration ... Read More »

Regulatory Strategies for Filing ANDA in European Union

A. Siva Priya*1, K. Uma Sankar2 *1Krishna Teja Pharmacy College, Tirupati, A.P, India 2Head of the Department, Pharmaceutics, Krishna Teja Pharmacy College, Tirupati, A.P, India A B S T R A C T A firm or company intended to market their drug products within the European Economic Area should initially get the marketing authorization from a competent authority of a ... Read More »

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