Key Development
This morning, August 10, 2026, the Ministry of Health (MOH) of Vietnam officially promulgated a landmark Circular detailing dossiers and procedures for drug and active pharmaceutical ingredient (API) marketing authorizations, executed by Deputy Minister Do Xuan Tuyen. The regulatory document serves as the primary instrument guiding the implementation of the 2016 Pharmaceutical Law (amended and supplemented under Law No. 44/2024/QH15), establishing an updated framework governing market authorization, clinical trial data, pharmacovigilance, and drug classification nationwide.
Key Regulatory Directives Under the New Circular:
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Validity Period of Marketing Authorizations (MA):
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Standard Duration: Valid for 05 years from the date of issuance or renewal.
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Reduced 03-Year Duration: Applied to pharmaceuticals requiring ongoing safety and efficacy monitoring (encompassing new chemical entities, vaccines, and biologics—excluding probiotics—granted initial MAs in Vietnam, alongside generic formulations matching new drugs whose 5-year benchmark has not elapsed).
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Provisional Validity Extension Framework: For MAs reaching expiration where the Drug Administration of Vietnam (DAV) has formally accepted a renewal application, the product MAY CONTINUE TO BE COMMERCIALLY DISTRIBUTED until the renewal is granted or until the DAV issues a formal rejection or suspension notice.
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Strict Submission Timelines for Renewals: MA renewal applications must be submitted PRIOR to the expiration date. Once an MA expires without a accepted renewal docket, the DAV will reject late filings, requiring the applicant to resubmit under “new marketing authorization” procedures.
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Standardizing Innovator Brands & Reference Biologics: Qualification as an Innovator Brand (Original Brand) or Reference Biologic requires comprehensive primary clinical data. In cases involving manufacturing site transfers, products retain these designations only if commercial titles, formulations, quality standards, and process equivalence are validated against US-FDA, EMA, WHO, or ICH standards.
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Enforcing 5 Safety Criteria for Over-the-Counter (OTC) Drugs: OTC drugs must demonstrate a broad safety margin, low toxicity, zero genotoxicity/carcinogenicity, suitability for short-term self-medication without physician supervision, low dependence/abuse potential, simple administration routes, and complete exclusion of toxic botanical ingredients.
Why It Matters
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Eliminating Marketing Authorization Renewal Backlogs: A structural highlight of the Circular is the provisional extension mechanism allowing drugs to remain in commercial distribution while renewal dossiers undergo DAV review. This resolves historical market supply freezes where active pharmaceuticals faced distribution halts due to administrative processing backlogs, securing uninterrupted drug supply for hospital networks.
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Establishing Corporate Compliance Accountability: Enforcing a strict cutoff that bars renewal submissions post-expiration compels domestic and multinational pharmaceutical manufacturers to submit renewal dockets well ahead of statutory deadlines.
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Reliance Pathway Integration: Applications processed under the international reliance pathway may be submitted within up to 05 years from the initial approval date by a recognized reference regulatory authority. This accelerates market entry for global innovative therapies targeting oncology, rare diseases, and cardiology.
Healthcare Insight Analysis
From the perspective of Healthcare Insight, the Ministry of Health’s promulgation of the implementing Circular for the Amended Pharmaceutical Law on August 10, 2026, represents a structural transition toward the International Harmonization of Pharmaceutical Regulations.
Historically, the primary market barrier in Vietnam’s biopharma sector centered on administrative processing lags for marketing authorizations. Pairing provisional validity extensions with post-market pharmacovigilance delivers three core strategic advantages:
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Transitioning to Post-Market Pharmacovigilance Oversight: Rather than relying exclusively on pre-market administrative gatekeeping, health authorities require periodic post-marketing safety reports. If safety risks or document falsifications are identified, the DAV maintains authority to suspend or revoke marketing licenses immediately.
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Protecting Innovator Brand Quality Integrity: Enforcing strict quality equivalence standards (aligned with ICH/FDA/EMA benchmarks) during manufacturing site transfers prevents quality degradation when multinational biopharmas execute local contract manufacturing technology transfers.
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Purging High-Risk Formulations from OTC Channels: Excluding toxic botanical ingredients from OTC classifications protects public health amid expanding self-medication trends.
Market Implications
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Unlocking Public Hospital Procurement Pipelines: Hospital procurement boards (e.g., Cho Ray, Bach Mai, HCMC Dept of Health) can confidently include pharmaceuticals undergoing active DAV renewal processing within public tender dockets, preventing localized drug deficits.
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Accelerating Technology Transfer & Localized Manufacturing: Multinational pharmaceutical corporations (Big Pharma) can execute local cGMP technology transfers to domestic manufacturing partners with regulatory clarity regarding Innovator Brand status preservation.
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Re-aligning Retail Pharmacy Product Catalogues: Major retail pharmacy chains (e.g., Long Chau, Pharmacity) must review active OTC inventories to ensure full compliance with the Ministry of Health’s five updated OTC criteria.
Regulatory Ledger: New MOH Pharmaceutical Marketing Authorization Circular
| Regulatory Vector | Standard Parameters & Provisions | Operational & Market Significance |
| MA Validity Period | 05 Years (Standard) | 03 Years (New drugs, vaccines, biologics) | Provides commercial stability for authorization holders. |
| Provisional Extension | Products remain active once DAV accepts renewal dockets. | Prevents market supply disruptions in hospitals. |
| Renewal Filing Cutoff | Mandatory submission PRIOR to expiration. Late = New filing. | Enforces strict regulatory compliance timelines. |
| Reliance Pathway | Submissions valid within $\le 05$ years of reference approval. | Accelerates market access for global innovative drugs. |
| OTC Classification | Must meet 5 safety criteria; ZERO toxic botanicals. | Safeguards consumer health during self-medication. |