Masterarbeit

The International Generic Drug Regulator Pilot (IGDRP) - A new approach to increase effectiveness in the field of marketing authorisations for generic medicines

Markus Meinhard (2015)

Summary
Language: English
This thesis focuses the International Generic Drug Regulators Pilot (IGDRP). The IGDRP aims to develop an international co-operation in the field of approval for generic drugs. The creation and evolution of the 3‑year pilot is described until the change to a perpetual program of international cooperation. That cooperation is not focused on the exchange of staff between the regulatory authorities, the reduction of workload should be done through the acceptance of elaborated documents. To achieve this objective of work reduction, the Assessment Report(s) and/or the Active Substance Master File (ASMF) will be taken from the leading authority by the cooperating agencies. This is possible because large parts of the global generic drug approvals are almost identical. In addition, the resulting advantages, disadvantages and challenges of the IGDRP are described.
Furthermore, it is described under Outlook, which further steps are needed in the author's opinion in order to provide in a sustainable way the global health systems with generic drugs.
Pages: 43