Yesterday (10 March 2023) released an updated word template that shall declare their worldwide registration status (WWRS) for all new applications for Generic Medicines.
In Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) has implemented a system called the QUEST (Quality Evaluation and Standards Team) system to evaluate the registration status of generic medicines in other countries.
In QUEST System, the Declaration of Worldwide Registration Status for Generic Medicines allows manufacturers or suppliers of generic medicines to declare their registration status in other countries.
In order for the NPRA to consider the registration of a generic medicine in Malaysia, this declaration is required. As part of the QUEST system, information about the registration status of the product in its country of origin, bioequivalence information, and other relevant details is provided.
The use of the QUEST system and the Declaration of Worldwide Registration Status for Generic Medicines has several benefits for patients, manufacturers, and regulatory agencies.
For patients: the process can expedite the availability of safe and effective generic medicines in the market.
For manufacturers: the process can reduce the time and cost associated with registration, as redundant testing and evaluation may not be necessary.
For regulatory agencies, the use of the QUEST system can enhance the efficiency and accuracy of the registration process, leading to a more streamlined and effective regulatory system.
Click this LINK to download the word template that needs to be used for declaring their worldwide registration status (WWRS) for all new applications for Generic Medicines in Malaysia.