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Malaysia Tests Regulatory Reliance To Speed Up Access To New Indications

 
• By Neena Brizmohun

The Malaysian agency’s drug review mechanism that relies on assessments by overseas regulators is now being tested for applications seeking approval for additional indications.

The Malaysian agency is making progress towards implementing reliance throughout the drug life cycle • Source: Shutterstock

Malaysia’s National Pharmaceutical Regulatory Agency has expanded the use of its regulatory reliance mechanism for assessing marketing applications for new drugs to include submissions for additional indications of already approved products.

The regulatory reliance process, which involves the NPRA relying on assessments already made by regulators in certain other jurisdictions, is being trialed in a pilot for applications for

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