Regulatory Impact Simulator
Evaluate market entry into Vietnam
Answer a few questions and we'll generate a tailored regulatory report — feasibility, roadmap, and estimated state fees.
-
1 Product
-
2 Origin
-
3 Specifics
-
4 Ingredients
What this simulator does
The Regulatory Impact Simulator is a four-step wizard that produces a diagnostic and planning report for a single product's regulatory pathway into Vietnam. From four input axes — product category (medicine / supplement / cosmetic), country of origin, detailed product profile, and ingredient composition — it returns the primary regulations that apply, an estimated processing-time envelope, the projected state fees, and the short-list of principal documents to prepare. Answers are stored in a Django session so you can pause and resume, or step back to edit earlier answers.
When to use this simulator
- Making a Go/No-Go decision on Vietnam market entry and need an early-stage estimate of regulatory cost and time.
- Preparing internal expectations and a question list before the first meeting with an appointed local partner.
- Prioritising a multi-product portfolio — comparing the relative regulatory burden across products.
- Existing MA holder evaluating initial impact when adding a new country of origin or extending dosage forms.
- Internal M&A due diligence — obtaining a snapshot of the target company's product regulatory status.
Inputs and outputs
| Step | Input | Branching effect |
|---|---|---|
| 1 | Product category (medicine / supplement / cosmetic) | Determines the entire applicable regulatory framework (Pharmacy Law vs. NĐ 15/2018 vs. ASEAN CD) and controls the question set for subsequent steps. |
| 2 | Country of origin (SRA vs. non-SRA vs. Apostille signatory) | Determines reliance-pathway eligibility, CPP consular-legalisation vs. Apostille requirement, and mutual-GMP-recognition availability. |
| 3 | Detailed product profile (dosage form, indication, strengths, packaging units) | Determines applicable Module structure, required clinical data level, and consolidated-application eligibility. |
| 4 | Ingredient composition (INCI names or ingredient list) | Runs the Ingredient & Substance Checker in the background, flagging any banned or restricted ingredients. |
Worked example — with numbers
Example: an FDA-approved oral generic (Atorvastatin Calcium 10 mg / 20 mg / 40 mg film-coated tablets, bottle packs, 90-count and 30-count variants). Sample wizard output:
- Framework: Pharmacy Law 105/2016 + 44/2024 amendment, Decree 163/2025/NĐ-CP, Circular 12/2025/TT-BYT (from 1 Oct 2026: Circular 32/2026/TT-BYT).
- Reliance pathway: US-FDA is on the Vietnamese SRA list, so the simplified evaluation pathway applies (within 5 years of first SRA approval).
- Consolidated application: the 3-strength series shares active ingredient and dosage form — likely eligible for the consolidated application under Circular 32/2026 (subject to the DAV implementation notice).
- Time estimate: SRA reliance pathway 6–9 months (Law 44/2024 target); add 3–6 months practical buffer.
- State fee estimate: based on Circular 41/2023/TT-BTC, with 50% reduction under Circular 64/2025/TT-BTC (2025-07-01 to 2026-12-31).
How the wizard maps to the DAV process
The wizard's four steps mirror the early stages of the actual DAV marketing-authorisation process. Steps 1 (product category) and 2 (country of origin) correspond to "Step 0 — pre-submission preparation" in the DAV workflow: determining MAH eligibility, CPP/FSC requirements, and GMP-recognition status. Step 3 (detailed profile) corresponds to the Module-structure determination inside "Step 1 — online submission". Step 4 (ingredient composition) maps to the raw-material specification section of Module 3 (quality) and pre-detects any regulatory-breach risk before the dossier is compiled. The wizard does not cover "Step 2 — completeness review" and beyond (technical evaluation, Q&A rounds, Advisory Council vote) — those are post-submission internal DAV steps that require continuous communication with the appointed local partner.
Primary regulatory basis
The simulator incorporates the following instruments as its primary reference basis: Pharmacy Law 105/2016/QH13, Pharmacy Law amendment 44/2024/QH15, Medical Device Decree 98/2021/NĐ-CP, Decree 07/2023/NĐ-CP (amending Decree 98/2021 to make số lưu hành indefinite), Decree 163/2025/NĐ-CP (implementing Law 44/2024), Circular 12/2025/TT-BYT (current drug-registration framework, in force to 2026-09-30), Circular 32/2026/TT-BYT (successor framework effective 2026-10-01), Circular 06/2011/TT-BYT (cosmetic notification, amended by TT 34/2025/TT-BYT), Decree 15/2018/NĐ-CP (food self-declaration), Circular 41/2023/TT-BTC and 59/2023/TT-BTC (state fees), and Circular 64/2025/TT-BTC (50% fee reduction from 2025-07-01 through 2026-12-31). All instruments are indexed in the legal register.
Estimate limitations — important
This is a tool for the diagnostic and planning stages. The time and fee estimates it returns are reference values based on the public regulatory text and standard processing pathways — they do not replace an official quote from DAV/IMDA/VFA or legal advice from an appointed local partner or counsel. Actual processing time depends on dossier completeness, the number of Q&A rounds, examiner workload, and administrative backlog. Fees are based on Circular 41/2023/TT-BTC and Circular 59/2023/TT-BTC; changes (e.g., extension or termination of the discount window under Circular 64/2025/TT-BTC) are updated in Ministry of Finance circulars. Ingredient screening results are drawn from public databases, but the Ministry of Health's prohibited-substance annexes may be updated monthly, and clinical-restriction thresholds may be revised via subsequent circulars. Currency estimates are quoted in Vietnamese Dong (VND) and should be interpreted against the current-day exchange rate at the time of application. The wizard does not model private-market costs — translation, notarisation, consular legalisation or Apostille service fees, local partner retainer, or third-party bioequivalence-study costs — which typically dwarf the state fees for a new chemical entity. This simulator does not offer registration services — final dossier compilation and filing are the responsibility of the appointed local partner.