Generic Drug Product Development: International Regulatory Requirements for Bioequivalence

Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative.

However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country.  This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.

• Introduction – Bioequivalence: International Regulatory Requirements, Isadore Kanfer
• Australasia (Australia and New Zealand), C.T. Hung; E. N. Bruhns; D.Ren; L. A. Folland; F.C. Lam and R.Smart
• Brazil, Margareth R.C. Marques, Silvia Storpirtis and Marcia M.Bueno,
• Canada, Iain J. McGilveray
• European Union, Roger K.Verbeeck and Joelle Warlin
• India, Subhash C. Mandal and S.Ravisankar
• Japan, Juichi Riku
• South Africa, Isadore Kanfer, Roderick. B. Walker and Michael F. Skinner
• South America and (Pan American Health Organization – PAHO), Silvia.S.Giarcovich and Ricardo Bolaños
• Taiwan, Li-Heng Pao, Jo-Feng Chi and Oliver Yoa-Pu Hu
• Turkey, İlker Kanzik and Atilla.A.Hincal
• United States of America, Barbara M.Davit and Dale P. Connor
• WHO, John D. Gordon, Henrike Potthaust, Matthias Stahl and Lembit Rägo