Drug Administration of Vietnam officially issued Guideline 7616-QLD-CL dated 21st May 2013,addressing at request for evaluating BE studies from manufacturers.
Pursuant to this Guideline, content and format of BE study report must conform to format of Asean guidelines or ICH.
There are two cases that BE study report should be submitted to VDA for evaluation. Details as follows:
- BE study report which is compulsory to be submitted with drug registration dossiers of some specific products only. List of these products are enumerated. Please click here.
1.1.Requirement for BE study center:
Documents prove legal basis of BE study center: BE study center have to provide one of these valid documents (original or copy version with legalization of Vietnam Embassy) :
- License or Certificate issued by Ministry of Health or Drug Administration of origin country prove that the Center has enough conditions to conduct a BE study.
In case no License or Certificate are available, BE study center can provide information and evidences proved that the Center is included in List of approved Center for BE study (issued by MOH)
- GCP(Good Clinical Practice) and GLP (Good Laboratory Practice) Certificate (conform to regulation of origin country) of BE study center issued by Competent Authority or Quality Control Organization
- In case, Clinical phase and Analysis Phase of study carry out in two separate Study Center, it is required to provide one of two documents mentioned in article 2.1 or 2.2 above for each Study Center
- Certificate which certify that BE study meet the requirements of GCP and GLP (according to regulation of origin country) inspected by MOH or Drug Administration of one of these countries: England, France, US, Japan, Australia, Canada or EMA (European Medicines Agency)
1.2. Requirements for Reference products used in study: please refer to Article 5 of Circular 08 (download here)
- BE study report for announcement of medicine having Bioequivalence proof (for any products that need to attend to tenders of local hospitals)
2.1. Requirement for BE sutdy ceter: please refer section 1.1 above
2.2. Requirements for Reference products used in study: please refer to Article II of Guideline 7616-QLD-CL (download here)
Reference documents of BE studies: