List of Product Requiring Bioequivalence (BE) Studies as Part of the Application for Marketing Authorization in Addition to Rifampicin and the 11 Products Listed in Bureau Circular No. 2006-008

In line with the mandate of the Food and Drug Administration of ensuring the availability of safe, efficacious and quality pharmaceutical products in the Philippines, Administrative Order No. 67 s. 1989: Revised Rules and Regulations on Registration of Pharmaceutical Products and Bureau Circular No. 01 s. 1997: Enforcement of the Requirement for Bioavailability Studies for Registration of Products Included in the List B (Prime) under Administrative Order No. 67 s. 1989 were issued to introduce the concept of Bioavailability/Bioequivalence to all stakeholders, highlight the importance of establishing interchangeability between innovator (originator) and multisource (generic) pharmaceutical products, and correspondingly require the submission of satisfactory BA/BE Study Reports.


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