The Malaysian National Pharmaceutical Control Bureau (NPCB) regulates the registration and authorization of manufacturing site changes for pharmaceutical production. There are five types of manufacturing site changes.
- Type I: Change of manufacturing site within Malaysia
- As a result of upgrading of facilities or expansion, etc.
- Type II: Change of manufacturing site from foreign country to Malaysia
- Type III: Change of manufacturing site outside Malaysia
- As a result of a merger or rationalization of manufacturing sites in line with multinational manufacturing strategies
- Type IV: Change of manufacturing site for special category of products
- Special products include vaccines, toxins, serums and allergens, blood products, and products derived from biotechnology.
- Type V: Crisis Situation
- These include natural disasters or closure or suspension of premises related to breach of product quality, safety, and efficacy.
Based on the type of site change, the NPCB requires different documentation in order to authorize the change of manufacturing site. A list of these documents, recently update in June 2003, can be obtained by contacting the National Pharmaceutical Control Bureau.