Applying Pharmacopoeias in Pharmaceutical Business and Drug Formulation

Circular 11 stipulates the application of Pharmacopeias (including the Vietnamese Pharmacopeia and foreign Pharmacopeias) for pharmaceutical business and medication preparation. To be specific:

Application of Vietnamese Pharmacopeia and reference pharmacopeias

Pharmaceutical business establishments and medication preparation establishments are permitted to apply the Vietnamese Pharmacopeia or one of the following reference pharmacopeias: European, British, United States, International, Japanese Pharmacopeias.

The application of standards in the pharmacopeias listed above must include all regulations on quality indicators, quality levels, and testing methods specified in the monographs of the corresponding drugs or drug materials in the applied pharmacopeia; including regulations on general quality indicators, quality levels, and general testing methods specified in the annex of the pharmacopeia.

In the case where a manufacturing establishment declares the application of one of the pharmacopeias listed above but uses testing methods different from those recorded in the specific monograph of the drug or drug materials in the selected pharmacopeia, it must demonstrate the equivalence between the manufacturer's testing method and the testing method recorded in the pharmacopeia. Testing results using the testing method recorded in the pharmacopeia are the basis for concluding the quality of the drug.

Particularly for herbal medicines, pharmaceutical business establishments and medication preparation establishments are permitted to apply the pharmacopeias listed above or the pharmacopeia of the country of origin of the medicine.

Application of other foreign pharmacopeias different from the cases of applying Vietnamese Pharmacopeia and reference pharmacopeias

In cases where pharmaceutical business establishments and medication preparation establishments apply a foreign pharmacopeia, the applied quality standards must at least meet the following requirements:

- Meet the requirements on quality indicators and quality levels specified in the corresponding quality standards monograph of the Vietnamese Pharmacopeia or one of the reference pharmacopeias;- The applied general testing method must be appropriate to the corresponding general testing method recorded in the Vietnamese Pharmacopeia or one of the reference pharmacopeias.

See details of Circular 11/2018/TT-BYT effective from June 20, 2018.

-Thao Uyen-

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