Application of Quality Standards in Drug Testing from March 16, 2020

Clause 2, Article 1 of Circular 03/2020/TT-BYT amends the regulations on the application of quality standards in the testing of drugs and drug raw materials as stipulated in Clause 1, Article 7 of Circular 11/2018/TT-BYT. It specifically states:

Illustrative image (source: internet)

- The testing must be conducted according to the approved and updated quality standards of drugs and drug raw materials. In cases where the quality standards of drugs and drug raw materials have not been updated, the testing facility shall apply the relevant pharmacopoeia as stipulated in Clause 1 and Clause 2, Article 6 of Circular 11, based on the production date of the batch of drugs or drug raw materials being tested.

The testing of concocted and formulated drugs at medical examination and treatment facilities shall be conducted according to the quality standards of drugs established and issued by the facility.

- In cases where the testing methods specified in the quality standards of drugs and drug raw materials have errors, do not ensure accuracy and precision, or the qualitative tests are not specific, or there are suspicions of additional drug/chemical substances in herbal medicines (drugs with side effects, drugs with unusual effects), or information from foreign drug regulatory agencies indicating the presence of impurities in drugs and drug raw materials, the State drug testing facility is authorized to apply analytical/testing methods stipulated in the pharmacopoeia or validated according to the guidelines for method validation specified in Appendix I issued with Circular 32/2018/TT-BYT dated November 12, 2018, by the Minister of Health regarding the registration for circulation of drugs and drug raw materials for testing and providing quality testing results. The head of the drug testing facility must be responsible for the testing results of their facility before the law.

For further regulations, see Circular 03/2020/TT-BYT, effective from March 16, 2020.

Thu Ba

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