Malaysia Regulatory Updates 3: BE



Implementation of requirement for BE studies for all generic “Immediate Release, Oral, Solid Dosage Form” products. Applicable to products containing Scheduled Poisons 

New Registration : 1st  January 2012 

Existing Products:  1st January 2014 upon submission for renewal

Accreditation of BE Providers/Centres

Inspections by NPCB auditors based on GCP and GLP Principals 

Local and Foreign Centres to be accredited by National Pharmaceutical Control Bureau (NPCB) 

Payment by Product Holder for foreign Centres inspection by NPCB: €5,000 Inspection Fee  + Actual travelling Expenses. Inspection report valid for 3 years after inspection 

Listing of approved BE Centres available on NPCB website .

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

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