Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has created a template for declaring the worldwide registration status of generic medicines in its Quest online submission system.
The template asks users to provide information including the name of the product, its application status, and the application type and registration number in the registered country. If the application type is the decentralized procedure, NPRA wants the applicant to include the reference member state on the form. The template supports the provision of information about multiple products.
NPRA has designed the template for use with all new applications for prescription generic medicines. The creation of the template follows NPRA’s publication of a guide to uploading bioequivalence study reports to the Quest 3+ online portal and its updating of the guidance notes for active pharmaceutical ingredient information for product registration.
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