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On September 5, 2022, the Ministry of Well being of Vietnam issued Round No. 07/2022/TT-BYT on medicine requiring bioequivalence (BE) research and necessities for dossiers reporting BE information when registering medicine in Vietnam (Round 07). Round 07 will take impact on November 1, 2022, changing Round No. 08/2010/TT-BYT guiding the reporting of bioavailability/bioequivalence information when registering medicine.
Round 07 consists of provisions on (i) generic medicine containing lively pharmaceutical substances (APIs) or having dosage kinds that require BE reporting when registering the medicine in Vietnam and (ii) dossiers for BE reporting of generic medicine.
Probably the most excellent level beneath Round 07 is that the listing of APIs requiring the submission of BE experiences of their drug registration file consists of 26 APIs as a substitute of 12 APIs as specified within the earlier round.
As well as, generic medicine having the next dosage kinds should have a BE report within the drug registration file:
- Medication in immediate-release dosage kind, with systemic results, containing APIs included within the listing of 26 APIs and never falling within the circumstances of BE reporting exemption,
- Medication in modified-release dosage kind, with systemic results, that don’t fall within the circumstances of BE reporting exemption.
Roadmap for Utility
From November 1, 2022, the registrants of the next medicine should submit a report on BE research information together with the drug registration file:
- Generic enteric-coated medicine, in immediate-release or modified-release kind, containing single APIs or fixed-dose API mixtures wherein the APIs are included within the listing of 26 APIs talked about above.
- Different generic medicine in modified-release kind, apart from enteric-coated medicine with APIs excluded from the listing of 26 APIs.
From November 1, 2025 (36 months after the efficient date of Round 07), the registrant should submit a BE information file together with the drug registration file for all generic enteric-coated medicine in modified-release kind.
From November 1, 2026 (48 months after the efficient date of Round 07), generic medicine containing APIs or dosage kinds requiring BE information which have been granted a Advertising Authorization (MA) beforehand have to be declared as medicine having paperwork proving bioequivalence.
Transitional Provisions
The MOH has arrange a versatile transition mechanism, permitting generic registrants to have the advantages from requesting a MA or acquiring BE research earlier than November 1, 2022.
For instance, the report on BE research information in drug registration/variation/supplementation dossiers submitted earlier than November 1, 2022, might proceed to adjust to the provisions of Round No. 08/2010/TT-BYT, until the MA holders voluntarily adjust to Round 07.
For medicine for which the registration dossiers have been submitted earlier than November 1, 2022, no further experiences on BE research information are required earlier than the MA is issued; nevertheless, the MA holders should adjust to the deadline of 48 months above after the drug is granted a MA.
For BE research, the solubility equivalence check ought to be carried out earlier than November 1, 2022, and may have paperwork proving the origin of the comparator drug or the dedication for the origin of the comparator medicine used within the research.
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