Bioequivalence and Bioavailability Forum

Hi RP,

❝ […] I have been unable to find the relevant Reference Product of Tripolidine for Malaysia.

Being “unable to find” is insufficient as a justification – make sure that it was either not registered or registered and is no more marketed in Malaysia. Then a foreign comparator can be used under certain conditions. See Section 3.1.2 of the applicable guideline:

• The selection of comparator product should be based on the selection criteria of ASEAN comparator product as follows:
  
  
  1. Innovator product and multiple manufacturing sites of the same innovator registered in the country is acceptable.
     
  2. If the innovator product used as comparator is not registered in the country, justification is required from the generic company to prove its interchangeability with the registered innovator (in vitro or in vivo).
     
  3. If the innovator product cannot be identified, the choice of comparator must be made carefully and be comprehensively justified by the applicant. The selection criteria of a comparator in order of preference are:
     • Approval in ICH and associated countries
       
     • Pre-qualified by WHO
     A well selected comparator must conform to compendia quality standards, if applicable.

• It is recommended to clarify with the regulatory authority regarding the choice of comparator product before the bioequivalence study is conducted.

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PS: RLD is an -term applicable only in Trumpistan.