Malaysia: Data Exclusivity
Basic
Information
Date
come in to force: Mar 01, 2011
Relevant
Directive: RAHAN BAGI MELAKSANAKAN DATA EKSKLUSIVITI DI
MALAYSIA (Click here
to view full directive)
Data Exclusivity under the Directive applies to: undisclosed, unpublished and non-public domain pharmaceutical test data relating to
- A new drug product containing a New Chemical Entity; and
- Second Indication of a registered drug product. Application for DE is to be made through the submission of the relevant documents required under the Directive to the Director of Pharmaceutical Services.
Timeline
New
drug product containing a New Chemical Entity: The application
for DE in relation to a new drug product containing a New Chemical Entity
must be made within 18 months from the date the product is first
registered or granted marketing authorisation; AND granted DE/Test Data
Protection in the country of origin or in any country, recognized and deemed
appropriate by the Director of Pharmaceutical Services.
Second
Indication: The application for DE must be made within 12
months from the date the second indication is approved; AND granted DE/Test
Data Protection in the country of origin or in any country, recognized and
deemed appropriate by the Director of Pharmaceutical Services.
Important
Definitions
New
drug product containing any New Chemical Entity:
A product that contains an active moiety that has not been registered in
accordance with the provisions of the Control of Drugs and Cosmetics
Regulations 1984. An active moiety is defined as the molecule or ion, excluding
those appended portions of the molecule that cause the drug to be an ester,
salt (including a salt with hydrogen or coordination bonds) or other noncovalent
derivative (such as a complex, chelate, or clathrate) of the molecule,
responsible for the physiological or pharmacological action of the drug
substance.
Second
Indication: A single or cluster of therapeutic indications
applied subsequent to the first indication(s) approved at the point of
registration of the product.
Period & Calculation of Data Exclusivity
A new drug product containing a New Chemical Entity:
- Period: The period of the DE shall not be more than 5 years.
- Calculation: Shall be from the date the product is first registered or granted marketing authorization AND granted DE/Test Data Protection in the country of origin or in any country recognized and deemed appropriate by the Director of Pharmaceutical Services.
For a Second Indication of a registered drug product:
- Period: 3 years
- Calculation: Shall be from the date the Second Indication is first approved AND granted DE/Test Data Protection in the country of origin or in any country recognized and deemed appropriate by the Director of Pharmaceutical Services.
Important link to view on going Data Exclusivity for A new drug product containing a New Chemical Entity & Second Indication: https://www.npra.gov.my/index.php/en/data-exclusivity
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