Data Exclusivity

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Data exclusivity refers to protection of undisclosed, unpublished and non-public domain pharmaceutical test data, the origination of which involves a considerable effort, submitted as required to the Director of Pharmaceutical Services for the purpose of scientific assessment in consideration of the:

Quality, safety and efficacy of any new drug product containing a New Chemical Entity

Safety and efficacy for a second indication of a registered drug product as a condition for registration of any new drug product containing a New Chemical Entity; or approval for a Second Indication of a registered drug product.

How to apply for DE?

An application for Data Exclusivity (DE) can be made via a Letter of Intent (LOI) in conjunction with the application for registration of a New drug product containing a New Chemical Entity or application for a Second Indication of a registered drug product.

The application must comply with all terms and conditions of the Directive: ARAHAN BAGI MELAKSANAKAN DATA EKSKLUSIVITI DI MALAYSIA; Bilangan 2 Tahun 2011. The LOI should be addressed and submitted manually to the Director of the National Pharmaceutical Control Bureau.

Click here to view template for the LOI
Click here to read on the Directive of Data Exclusivity

Register of Data Exclusivity Granted in Malaysia (New Drug)

Register of Data Exclusivity Granted in Malaysia (Second Indication)