EMA expands generic assessment pilot globally in response to industry

By Dan Stanton

- Last updated on GMT

EMA expands generics assessment sharing outside EU
EMA expands generics assessment sharing outside EU

Related tags Food and drug administration Pharmaceutical industry European union

The EMA has responded to feedback from generic drugmakers by broadening an assessment sharing pilot to regulators outside the EU.

The European Medicines Agency began an initiative last year to share assessments reports for generic medicines in support of the International Generic Drug Regulators Pilot (IGDRP), and has now extended this to include regulators outside the EU.

The IGDRP began in 2012 to strengthen generic development and approval procedures globally and involves the European Directorate for the Quality of Medicines & Healthcare (EDQM) and the World Health Organization (WHO).

“The objective of the pilot is to provide for a more efficient and consistent review process while at the same time reducing regulatory burden and facilitating the similar timing of market authorizations across jurisdictions,”​ EMA spokesperson Monika Benstetter told in-Pharmatechnologist.com.

“The extension to the centralised procedure that was announced yesterday was made in response to requests from industry for broadening this initiative,”​ she added.

While the pilot was initially launched for medicines subject to the decentralised procedure in the EU, this extension will see collaboration with regulators in Australia, Canada, Chinese Taipei and Switzerland, with other members of the IGDRP – including Brazil, China, Japan, Korea, Mexico, New Zealand, Russia, Singapore and South Africa – potentially taking part in the future.

For generic drugmakers, she said “participation in the pilot would offer applicants the potential to obtain market authorization in chosen markets as part of a coordinated process.

“Experience gained by industry and regulatory agencies would help to refine the process and inform other information and work sharing models currently under consideration by regulatory agencies.”

We asked the EMA whether regulators for the largest pharma market, the US, would be involved in this pilot:

“Extending the pilot to other countries will depend on requests from industry and requests from other regulators.”

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