Strategic priorities of the consortium include the establishment of a framework for the exchange of information on evaluation among regulators, promoting convergence of technical standards and data and alignment of administrative and regulatory assessment procedures and instruments.
Context
The official launch of the regulation of the International Pilot Project of generic medicines for three years in 2012 explored the possibilities of information exchange and work around generics. Following a successful pilot project and with keen interest to collaborate, a group of regulators launched the International Drug Regulatory Program (IGDRP) have been renamed in 2015.
Participating agencies and organizations include the US Food and Drug Administration (FDA), Health Canada, the European Medicines Agency (EMA), the China Food and Drug Administration (CFDA), the Japanese Ministry of Health, Work and Good among others.
The IGDRP currently working on several projects:
Strategic Priorities / Objectives
The IGDRP seeks to carry out a pilot project on the exchange of information among IGDRP members, to research and develop reference documents summarizing the similarities and differences between regulators on issues of "regulatory convergence or harmonization of national guidelines."
The group will also seek to develop tools / mechanisms for the exchange of evaluation reports and other documents may contain confidential business information among regulators.
In addition, the development of databases to identify ASMF / DMF and applications submitted to regulators for registration of generic drugs will be another goal.
The group of more advanced regulatory agencies will also seek to assist people with less technical expertise that allows capacity-building activities (eg joint review of information quality and bioequivalence a generic application) to better understand the interpretation and Implementation of regulatory procedures; In common use.
The performance and impact of the program will be evaluated in the periodic stages according to the December report and an IGDRP logical model and a results matrix and IGDRP has been developed data to help evaluate program effectiveness.
