Malaysia Regulatory Updates 3: BE

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MALAYSIA - REGULATORY UPDATES 3:

BIOEQUIVALENCE (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
 



About the Author

Many years in the Healthcare Industry, his extensive network and current active participations in various Projects with the Government and NGOs in policies formulation and input, development and implementation of strategies and action plans enable him to keep abreast with the changing, transforming roles and dynamism of the Industry and its ecosystem.

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