The Health Sciences Authority (HSA) has updated its regulatory guidance for the registration of therapeutic products to improve efficiency and clarify submission requirements.

• New Submission Pathway: A pathway for “Standard Essential Medicines” has been introduced, allowing the registration of certain unregistered medicines via Generic Drug Applications.
• GMP Conformity: A new procedure allows companies to request HSA inspections for overseas manufacturing sites if evidence of compliance is unavailable at the time of application.
• Compliance Rule: Applications will now only be accepted for screening if 100% of required documents are submitted; incomplete dossiers face immediate rejection.

This summary is based on updates issued by the Health Sciences Authority.