Which Documents Are Required for the Registration Dossier for Bioequivalence Studies of Drugs?

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It has been reported that upcoming regulations will cover the bioequivalence testing of drugs. Could you please inform me what types of documents are included in the registration dossier for bioequivalence study of drugs?

According to the provisions in Clause 1, Article 7 of Circular 10/2020/TT-BYT (Effective from August 10, 2020), the dossier for registration of bioequivalence studies of drugs includes:

- An application for conducting bioequivalence studies of drugs according to Form No. 03 issued together with this Circular;

- The dossier containing information about the drugs for bioequivalence testing: name of the drug, active ingredient name, components, concentration/strength, dosage form, and other related information (if any).

Sincerely!

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