Snapshot

The Conditional Registration for Pharmaceutical Products During Disaster pathway has been developed by the National Pharmaceutical Regulatory Agency of Malaysia.

This pathway can be used where new pharmaceutical products (including vaccines) for use during a disaster..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

All registration applications for pharmaceutical products during disaster that fulfills the conditions will be given priority review in which a maximum of 70 working days would be needed to complete the evaluation. If the product has been conditionally approved or given emergency use authorization or listing by any DCA reference countries or WHO (hereby referred as Recognition Pathway), the time taken for reviewing process would be significantly shorten.