Generic Medicines

Shared Evaluation of Generic Applications

The past decade has seen numerous drugs come “off patent” and a consequent increase in the number of generic products seeking approval.

In April 2012 the International Generic Drug Regulators Programme (IGDRP) instigated a pilot programme for the shared evaluation of generic applications. The European Decentralised Procedure (DCP) was used as the model for data […]

By |February 10th, 2015|Generic Medicines|0 Comments

Registration of Generic Medicines with the TGA

Generic medicines are those products which are ‘essentially similar medicines’ to the innovator. To qualify as a generic, it is necessary to have the same quantitative and qualitative composition for the active substance, the same pharmaceutical form and to show bioequivalence. If these conditions are met, generic medicines can piggy-back on the innovator’s scientific […]

By |September 12th, 2014|Generic Medicines|0 Comments