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
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