Snapshot

The Conditional Registration for New Chemical Entities and Biologics in Malaysia pathway has been developed by the National Pharmaceutical Regulatory Agency of Malaysia.

This pathway can be used where New registration applications for new chemical entities and biologics..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from EU-EMA United States WHO

Target time assessment is The timeline for conditional registration will follow a standard evaluation timeline for new chemical entities and biologics applications (245 working days). However, in line with the objective of the conditional registration to facilitate earlier access to vital medicines, priority review may be considered upon request based on justification provided by the PRHs..