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On May 30, 2018, the Ministry of Health Malaysia and National Pharmaceutical Regulatory Agency (NPRA) issued the Directive to implement Guidelines on Conditional Registration for New Chemical Entities and Biologics.

The conditional registration is set to allow certain promising new medicines to reach patients with unmet medical needs earlier than the current framework while ensuring appropriate measures are in place to manage risks inherent in the fact that the additional data are still required.

This new guideline provides instructions on the application necessary for implementation of conditional registration. It forms the basis for requesting or renewing a conditional registration and should be allowed unless otherwise justified.

The registration holder must comply with the requirements of the guidelines on conditional registration for new chemical entities and biologics beginning June 1, 2018.

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