The pharmaceutical sector is a regulated business, making the development and improvement of the legal and regulatory framework crucial to providing a sound basis for the production, trading, distribution, quality control and use of medicines. Regulations also serve as the “rails” for development, enabling faster access to new medicines, creating a transparent investment environment for businesses and providing stronger protection for the public against market fluctuations.
Dr Vu Tuan Cuong, Director of the Drug Administration of Viet Nam under the Ministry of Health, said that from the initial provisions of the Law on People’s Health Protection, the pharmaceutical sector had the 2005 Law on Pharmacy, the 2016 Law on Pharmacy and the 2024 Law Amending and Supplementing a Number of Articles of the Law on Pharmacy. Each revision of the legal framework has represented an upgrade to the management system to meet emerging requirements, ranging from quality control and price management to disease prevention and control, rare medicines, high-tech medicines, vaccines and biological products.
The management of medicines and cosmetics has continued to become more substantive, with fewer administrative procedures, greater decentralisation and transparency, and a gradual shift from document-heavy pre-market controls towards post-market controls based on data and accountability. The number of administrative procedures in the pharmaceutical and cosmetics sectors has been reduced from 124 to 75, making processes faster and clearer and easing the burden on businesses, while maintaining requirements for quality, safety and efficacy.
On the basis of the law, the Ministry of Health has issued circulars regulating the quality management of medicines and pharmaceutical ingredients, medicine registration and other areas. Notably, provisions from foreign pharmacopoeias have also been applied in Viet Nam. Accordingly, manufacturers of chemical medicines, vaccines and biological products may apply the Vietnamese Pharmacopoeia or reference pharmacopoeias, including those of Europe, the UK, the US and Japan.
The Vietnamese Pharmacopoeia has been continuously supplemented and updated. To date, the Vietnamese Pharmacopoeia V contains 1,722 standards, including 1,490 national technical standards for medicines, pharmaceutical ingredients and packaging materials in direct contact with medicines, and 232 national technical standards for testing methods.
The pharmaceutical sector has also established and consistently applied a system of Good Practices (GPs) based on World Health Organisation (WHO) guidelines throughout the medicine life cycle. These include Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Storage Practices (GSP), Good Distribution Practices (GDP), Good Pharmacy Practices (GPP) and Good Clinical Practice for medicines. This provides a consistent foundation for ensuring medicine quality from production and storage to distribution and use.
The review and issuance of marketing authorisation licences, as well as dossiers for the registration of medicines and pharmaceutical ingredients, have now been standardised in accordance with the ASEAN Common Technical Dossier (ACTD), while also being compatible with registration dossiers applied in the EU, the Republic of Korea and other markets.
Medicine quality control is carried out through both pre-market and post-market measures. Under the pre-market system, all medicine manufacturers and businesses must implement and be assessed as meeting Good Practices standards for manufacturing, trading, quality testing and storage.
Accordingly, establishments must meet GMP requirements for manufacturing, GLP for testing laboratories, GDP for distribution, GSP for storage and GPP for retail pharmacies. Overseas medicine manufacturers must provide evidence of compliance with WHO-GMP or other standards such as PIC/S-GMP and EU-GMP, and must undergo assessment and appraisal by the Vietnamese Ministry of Health in accordance with the Law on Pharmacy.
Before a medicine can be granted marketing authorisation, the Ministry of Health must assess its registration dossier, covering pharmaceutical ingredients, manufacturing processes, quality standards, stability and clinical data. Registration dossiers comply with the ASEAN Common Technical Dossier and are consistent with medicine registration requirements in countries around the world. Medicines, ingredients, excipients, packaging and finished products must meet the standards set out in the Vietnamese Pharmacopoeia and recognised international pharmacopoeias.
Medicines manufactured domestically or imported must undergo quality testing before being placed on the market. Manufacturers and importers may only release batches that have been tested and meet the registered and approved quality standards. Products considered to carry a high quality risk, such as vaccines and biological products, as well as medicines from overseas manufacturers whose products have previously violated quality standards, must undergo additional testing by a GLP-compliant testing facility designated by the Ministry of Health before being placed on the market.
Post-market controls are also conducted regularly and rigorously. Every three years, the Drug Administration of Viet Nam and provincial-level Departments of Health inspect whether manufacturing, trading, storage and testing establishments continue to meet Good Practices requirements. Every year, health authorities from central to local levels conduct regular inspections, including both planned and surprise inspections, of pharmaceutical manufacturers and businesses. Violations are dealt with and penalties imposed in accordance with the law.
Medicines during production and circulation are also subject to sampling and quality surveillance by the nationwide state testing system, comprising three central-level testing institutes and a network of testing centres in provinces and cities. Every year, the testing system collects tens of thousands of medicine samples from the market for quality assessment. Quality surveillance sampling focuses on medicines considered at higher risk of quality problems and products from manufacturers whose medicines have previously failed to meet quality standards.
Thanks to the comprehensive legal and regulatory framework for medicine quality management and the full system of technical standards and regulations, strict quality controls for medicines and pharmaceutical ingredients have helped keep the proportion of substandard and counterfeit medicines in Viet Nam low compared with other countries in the region. The proportion of medicines failing to meet quality standards remains below 1.0%, while counterfeit medicines account for less than 0.1% of the samples tested. All batches found to violate quality requirements are recalled or otherwise handled in accordance with regulations.
