ADVISORY COUNCIL OF ADMINISTRATIVE REFORM RESULT OF AP’S PRIORITY REVIEW PHARMACEUTICAL SECTOR Presented by Dr. MATTHIAS DUEHN HEAD OF PHARME WORKING GROUP – ADVISORY COUNCIL. Administrative Procedures Reviewed:.
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ADVISORY COUNCIL OF ADMINISTRATIVE REFORM
RESULT OF AP’S PRIORITY REVIEW
Presented by Dr. MATTHIAS DUEHN
HEAD OF PHARME WORKING GROUP – ADVISORY COUNCIL
EuroCham; AmCham; MOH; OOG; Pharma group
Collect legal documents; relevant information
Adding comment & feedback from 1st meeting
1st group discussion
Consolidate overall review report
2nd Group discussion
The duration of license to foreign enterprises is currently two (2) years only, whilst MA (Marketing Authorization) the duration of license for imported drugs for domestic companies in Vietnam is five (5) years.
This rule is unequal treatment of Vietnamese domestic and foreign enterprises and violates Vietnam’s WTO-commitments.
Revise Article 11 in TT17/2001/TT-BYT dated 1/8/2001. We propose to extend the validity period for foreign enterprises to five(5) years to guarantee equal treatment between foreign and domestic enterprises. MOH has already taken up this recommendation in “Draft 16”, so this is good news!
AP 2: Registration of foreign new drug and pharmaceutical raw material business in Vietnam
2. Requirement of “Certificate of Pharmaceutical Product (CPP)” from manufacturing country
3. Certificate of Analysis (COA) of pharmaceutical product with original signature from end-manufacturer
4. Identical trade name on Certificate of Pharmaceutical Product (CPP):
5. Certificate of Analysis (COA) for drug stability study.
6. Lead time for dossier evaluation:
7. Elimination of one-year validity period for some pharmaceutical products:
8. Requirement of clinical trials in Vietnam for innovative medicines:
9. No automatic data protection:
10. Providing additional information of drug safety / Updating leaflets
11. Receipt of drug registration dossier submission
Switch from issuing license (receipt) to post evaluation mechanism. The MOH should detail more regulations for drug advertisement like allowed information (ex. advertise only registered information or only within the registered indications, administration guidelines). In case violation, enterprise should be penalized. Therefore, enterprise need to know more about legal aspect and control their activities. This mechanism is likely applied by most of countries in the world.
In case of drug quality test is done in Vietnam, it needs to:
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