Malaysia Regulatory Updates 1: DE & API


1) DATA EXCLUSIVITY (DE). Directive effective: 1st March 2011

New Chemical Entities (NCE):  Application within 18 months from date of first registration  Duration: 5 years granting of DE in country of origin

Second Indication of registered product: Application within 12 months from approval of second indication. Duration: 3 years

Exclusion: Compulsory Licensing, National Emergency etc. Not applicable to Biologics/Biotechnology Products.

API requirements for new drug applications implemented in stages:

2.1) New Chemical Entities (NCE)
         April 2011 : Voluntary 
         January 2012 : Mandatory

2.2) Generics : In stages according to risk
          Injectables/Parenterals :  Tentative January 2014
          Others: To be decided

2.3) Other issues:
          Existing Products: To be decided 
          GMP Standards:  PIC/S, WHO

Source: 7-9 May NRC 2013_National Pharmaceutical  Control Bureau


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