What does the Quality Dossier for Contract Manufacturing Drugs for Export Include?

Export Quality Dossier for Contracted Pharmaceuticals (Not for Domestic Circulation)

The quality dossier for contracted pharmaceuticals for export (not for domestic circulation) is guided by Circular 23/2013/TT-BYT and includes: technical standards, methods of drug testing, drug manufacturing processes, and stability study documents (accepting results of accelerated aging under extrapolated shelf life conditions) provided by the contracting party; Testing Certificate for contracted drugs provided by the contract manufacturer.

Illustrative image (source: internet)

At the same time, the quality dossier for contracted pharmaceuticals for export does not require the submission of a bioequivalence study report, preclinical, and clinical dossiers.

Besides the regulation on the quality dossier for contracted pharmaceuticals for export, Circular 23/2013/TT-BYT also regulates the quality dossier, preclinical and clinical dossiers as follows:

- Quality Dossier: Applied according to the ASEAN Common Technical Dossier (ACTD) and technical guidelines provided in Circular 22/2009/TT-BYT, including:

- Technical standards, methods of drug testing, and drug manufacturing processes provided by the contracting party;- Testing Certificate for contracted drugs provided by the contract manufacturer.

- Preclinical and Clinical Dossiers: Applied according to the ASEAN Common Technical Dossier (ACTD) and technical guidelines stipulated in Circular 22/2009/TT-BYT.

The drug registration establishment must pay all fees related to drug registration and circulation in accordance with the law on fees and charges.

See additional regulations at Circular 23/2013/TT-BYT effective from October 01, 2013.

Thu Ba

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