Data exclusivity refers to protection of undisclosed, unpublished and non-public domain pharmaceutical test data, the origination of which involves a considerable effort, submitted as required to the Director of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.
Register of Data Exclusivity Granted in Malaysia (New Drug)
- Register of Data Exclusivity (updated 10 November 2017)
Register of Data Exclusivity Granted in Malaysia (Second Indication)
- Register of Data Exclusivity for AI (updated 26 December 2017)