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Regulations on drugs subject to bioequivalence testing and requirements for bioequivalence test dossiers in circulation registration in Vietnam-Inviting inputs/suggestions
 

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PXL/HO/Cir-093/2021-22                                                                                      Date: 02.11.2021

Hyderabad

 

 

Dear Sir/Madam,

 

Subject: Regulations on drugs subject to bioequivalence testing and requirements for bioequivalence test dossiers in circulation registration in Vietnam-Inviting inputs/suggestions.

 

We would like to bring to the kind notice of member companies that Pharmexcil is in receipt of the subject Circular (draft) Dt: 27.June.2021through the Mission that the Ministry of Health, Vietnam have proposed few regulations on drugs subject to bioequivalence testing and requirements for bioequivalence test dossiers in circulation registration in Vietnam.

 

This Circular stipulates:

 

  • Generic drugs containing active ingredients and dosage forms must report bioequivalence test upon registration for circulation in Vietnam;
  • Bioequivalence test records of generic drugs.
  • The instructions in this Circular only apply to pharmaceutical drugs that have systemic effects after being absorbed into the general circulation.
  • Vaccines, biological products, herbal medicines and traditional drugs are not regulated by this Circular.

 

We request member companies to kindly go through the Circular draft and provide your inputs/suggestions if any, to enable Pharmexcil take up the matter with the concerned Department.

 

We look forward to receiving the inputs Through the link given below by 05.Nov.2021.

 

CLICK TO ENTER INPUTS/SUGGESTIONS

 

 

With regards,

 

 

 

Uday Bhaskar
Director General