Do generic medicine producers have access to the (non-clinical) data of reference products?
No. In fact, reference medicine data are never revealed to third parties; thus they cannot be used by generic producers. They must research and develop their own formulation of the product for approval. However, they may refer to published clinical data concerning the safety and efficacy of the reference product.
Related Questions
- Are there exceptions when Subutex and Suboxone or approved generic versions of these products may be administered by a practitioner without the DATA 2000 waiver?
- Do generic medicine producers have access to the (non-clinical) data of reference products?
- Do generic manufacturers have access to data of originator products?
