The Drug Administration of Vietnam, operating under the Ministry of Health, has issued a formal administrative sanction against US Pharma USA Joint Stock Company (headquartered at Lot B1-10, D2 Street, Northwest Cu Chi Industrial Zone, Bau Tre 2 Hamlet, Tan An Hoi Commune, Ho Chi Minh City), locking in a total fine of 175 million VND. The regulatory enforcement was executed after investigators identified multiple non-compliant practices concerning the firm’s document retention workflows and its failure to process required updates for its commercial drug marketing authorizations.
The explicit administrative parameters and statutory violations recorded for the pharmaceutical manufacturer include:
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Non-Compliance in Data Retention and Clinical Safety Data: US Pharma USA failed to retain comprehensive drug registration dossiers as legally mandated. Furthermore, the manufacturer neglected to supply critical information regarding its registered medicines to competent state management agencies upon the emergence of data or objective evidence concerning the clinical safety and efficacy of the drugs during active market circulation.
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Unauthorized Commercialization Prior to Variation Approvals: The enterprise failed to execute regulatory procedures to amend or supplement its official Certificates of Marketing Authorization with competent authorities, illegally placing 12 non-compliant drug products into market circulation prior to securing required approvals for major and minor variations.
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Neglecting Notification Directives and Legal Frameworks: Regarding localized minor variations that strictly require pre-market notification, the corporation failed to submit formal updates to competent state bodies for 6 specified medicines. The entire matrix of these administrative infractions is governed and penalized under Article 56 of the Government’s Decree No. 117/2020/ND-CP, which regulates administrative sanctions across the healthcare sector.
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Enforcement Mandates and Legal Escrow: The Drug Administration has ordered US Pharma USA Joint Stock Company to strictly comply with the administrative fine. Regulatory authorities specified that if the designated compliance deadline lapses and the enterprise fails to voluntarily execute its financial obligations, state enforcement mechanisms will be deployed to legally compel compliance under the framework of the law.