According to Circular No. 22/2009/TT-BYT dated November 24, 2009 of the Vietnam Ministry of Health on registration of drugs, for some specific product, apart from ACTD dossier, it is also requested to submit BE study to VDA for evaluation.
BE study is considered along with ACTD dossier. Visa number could only be granted for the product if both BE study and ACTD dossier is accepted by VDA

The BE (bioequivalent) studies should be conducted according to following regulation:
Circular No. 08/2010/TT-BYT dated 26 April 2010 regarding guideilnes for reporting research data of bioavailability/bioequivalence of drug registration. BE studies should be conducted in BE study center that meet GLP and GCP standard. The certificate of GLP and GCP should be submitted to VDA for evaluation

Article 4. Provisions for research bioavailability / bioequivalence
1. Research must be designed and implemented in accordance with the study guide of bioavailability / bioequivalence study of ASEAN or the similar guidance of other organizations (such as the World Health organization (WHO) , International Conference on harmony (ICH), the U.S. Food Drug Administration (U.S. FDA)). For studies conducted in Vietnam, before conducting the research, research proposals must be evaluated and approved by specialized technical agencies authorized by the Ministry of Health.
(For Asean Guidelines for the conduct of Bioavailability and Bioequivalence studies, Please click here)

List of active ingredients that need to have bioequivalent study in registration dossier

No.	Active ingredient	Reference product (dosage form – strength/concentration)	Manufacturer (country of manufacturer – country of licensing)
1	Amlodipin	Amlor- Capsule 5mg.	Pfizer PGM (France)
2	Azithromycin	Zithromax- Powder for oral suspension 200mg/5ml	Pfizer Italia (Italia)
3	Carbamazepin	Tegretol- Tablet 200mg.	Novatis Pharma S.p.A (Italia)
4	Cefixim	Oroken*- Film coated tablet 200mg; Powder for oral suspension 40mg/ 5ml và 100mg/ 5ml ; Granule for oral suspension 40mg và 100mg.	Famar Lyon (France)
5	Cefuroxim Axetil	Zinnat- Film coated tablet 125mg, 500mg	Glaxo Operation UK Ltd. (UK)
6	Clarithromycin	Klacid- Film coated tablet 250mg, 500mg. Klacid- Granule for oral suspension 125mg/5ml.	Abbott Laboratories Ltd. (UK) PT Abbott Indonesia (Indonesia)
7	Glibenclamid	Daonil** - Tablet 5mg	Aventis Pharma (Japan)
8	Gliclazid	Diamicron- Tablet 80mg.	Les Laboratoires Servier Industrie (France)
9	Metformin	Glucophage- Film coated tablet 500mg, 850mg, 1000mg.	Merck Sante s.a.s. (France)
10	Metoprolol	Betaloc- Tablet 50mg.	AstraZeneca (Philipine)
11	Nifedipin	Adalat- Softgel 10mg.	R.P. Scherer GmbH & Co. Germany (Germany)
		Adalat*- Softgel 5mg,	Bayer Health Care (Germany)
12	Rifampicin	Rimactane*- Tablet 150mg.	Novatis (Switzerland)

 

* This product is not circulated in Vietnam. The product is bought from the manufacturing country.

** This product is not circulated in Vietnam. The product is bought from the licensing country