Snapshot

The Conditional Marketing Authorization pathway has been developed by the Drug Regulatory Authority of Pakistan of Pakistan.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia Austria Canada Denmark EU-EMA Europe France Germany Japan Netherlands Norway Sweden Switzerland United Kingdom United States

150 working days. The timeframe is calculated after a priority determination process, from acceptance of application dossier for evaluation through to the decision of the Registration Board.