Talking generically

The International Generic Drug Regulator Pilot (IGDRP) was launched in April 2012 to promote collaboration and convergence in generic medicines regulatory programmes in order to address the challenges posed by increasing workloads, globalization and complexity of scientific issues.

The European Union (EU), using the DCP (Decentralised Procedure) as a model, is leading an international pilot project through which, upon request from a generic pharmaceutical company, it will share the assessment reports generated as part of the DCP assessment procedure in real time with collaborating regulatory agencies outside the EU.

The first phase of this project involves the EU, Australia, Canada, Chinese Taipei and Switzerland. Other members of IGDRP – which includes Brazil, China, Japan, Korea, Mexico, New Zealand, Russia, Singapore and South Africa – may decide to take part in the pilot programme at a later stage.

A generic drug applicant wishing to market the same ‘generic’ product in the EU through the DCP and in other jurisdictions that form part of the IGDRP are invited to participate in this pilot programme, provided they fulfil the eligibility criteria which are: synchronized filling of the application in at least one of the IGDRP member states; no major safety, efficacy or quality differences; complete compliance with the regulatory requirements of the participating countries, including those of in-vitro and in-vivo comparative studies; completed Summary of Quality Differences form; consent granting permission for the sharing of the DCP assessment report with non-EU agencies; and prior experience of DCP submission.

The DCP Pilot will involve a parallel review process, with non-EU agencies continuing to conduct separate but synchronised receipt, validation/screening, assessment and approval or refusal steps, using the outputs from the Assessment phase I and Assessment phase II of the EU DCP.