Malaysia Regulatory Updates 2: Product Registration

MALAYSIA - REGULATORY UPDATES:

GOOD MANUFACTURING PRACTICE (GMP)

In order for imported Products to be registered with the National Pharmaceutical Control Bureau, the Product must be:
1) Manufactured in a PIC/S or ICH country or 2) Manufacturing facility must be inspected and  compliant to PIC/S GMP guidelines by a National Drug Regulatory Agency of a PIC/S or ICH Member Country or 3) ASEAN Member State listed in ASEAN Sectoral Mutual Recognition Arrangement for GMP
Exemption Clause:

  Unmet Medical Needs  –  Orphan Drugs 
      Life-Saving Products  –  Oncology/Anti-Retrovirus  
      National Emergency  –  Pandemic  
      Technology Transfer

Implementation date:

       1st  July 2012: new registration of pharmaceutical products
       1st  January 2014: product registration renewal

 

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