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Malaysian guidelines for generics Posted 29/07/2011

The Ministry of Health Malaysia through the National Pharmaceutical Control Bureau (NPCB), which was set up in 1985, is the Malaysian authority that assures the quality of medicines in the country.

The NPCB is in charge of ensuring that all pharmaceutical and health products in the Malaysian market are of quality, safe and efficacious, regulated according to relevant legislations and used rationally.

With the increasing availability of generic products in the Malaysian market, it is imperative that the Ministry of Health Malaysia introduces a mechanism to further ensure that the available generic products are therapeutically equivalent to the innovator’s products and are clinically interchangeable. In practice, demonstration of bioequivalence is generally the most appropriate method of substantiating therapeutic equivalence between medicinal products.

The objective of the Malaysian guidelines for ‘the conduct of bioavailability and bioequivalence studies’ is to ensure that bioequivalence studies in Malaysia are conducted according to the international ethical and scientific standards based on good science

In Malaysia, guidelines for bioequivalence of generics were published by the NPCB in September 2000.

Bioequivalence guidelines
These guidelines are specifically related to bioequivalence studies for prescription generic products:

The conduct of bioavailability and bioequivalence studies
14 September 2000
portal.bpfk.gov.my/index.cfm?menuid=46&parentid=15

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Malaysian guidelines for biosimilars

Source: NPCB, WHO

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