Proposing specific policies, solutions, investments, and research and development for the Vietnamese biopharmaceutical industry.

On the morning of May 28, 2025, the conference “Developing Vietnam’s Biopharmaceutical Industry” was held in Hanoi. Attending the conference were Deputy Minister of Health Do Xuan Tuyen, representatives from several departments and units under the Ministry of Health, along with numerous experts, researchers, and representatives from pharmaceutical companies in Vietnam.

In his opening remarks, Deputy Minister of Health Do Xuan Tuyen stated that the Vietnamese pharmaceutical industry has made significant progress in recent years, contributing importantly to ensuring an adequate supply of medicines for disease prevention, treatment, and healthcare for the people. The number of pharmaceutical factories has increased from 228 to 242, including 21 factories meeting EU-GMP standards. Domestically produced medicines include over 800 active ingredients belonging to all 13 essential drug groups according to WHO classification, accounting for approximately 60% of the quantity used and 46% of the value. Notably, the number of original branded drugs with technology transferred from multinational corporations has increased from 9 to nearly 30. Vietnam has also produced 14 types of vaccines for 10 diseases in the Expanded Immunization Program, along with several biotechnology products such as interferon, insulin, Darbepoetin Alfa, and Etanercept.

However, the Vietnamese pharmaceutical industry still has limitations. Domestically produced drugs are mainly generics. The number of facilities producing biological and biotechnological drugs is still modest, with six vaccine manufacturing plants, one biotechnology drug manufacturing facility, and two facilities currently under research and development. Biological products mainly focus on a few vaccines produced using conventional technology; there are not many highly effective biological products used in the treatment of specialized, critical diseases or emerging epidemics. The research and development capacity of enterprises is still limited, failing to keep up with and apply modern biotechnologies.

Recognizing the role and advantages of biotechnology, especially biopharmaceuticals, in enhancing the research, development, and industrial production capacity of the domestic pharmaceutical sector, the Vietnamese government has recently issued many important policies and regulations.

Resolution No. 36-NQ/TW of the Politburo dated January 30, 2023, on the development and application of biotechnology, has identified a superior policy for developing high-value biotechnology products in medicine and pharmaceuticals, while promoting research and production of drugs, vaccines, stem cell technology, gene technology, and biological drugs. The resolution also identifies support for biotechnology enterprises in accessing new technologies, intellectual property, industrial-scale production, brand building, and product commercialization.

Decision No. 1165/QD-TTg dated October 9, 2023, of the Prime Minister approved the National Strategy for the Development of Vietnam’s Pharmaceutical Industry until 2030, with a vision to 2045. The goal by 2030 is for domestically produced medicines to meet 80% of demand and 70% of market value, with 20% of raw materials produced domestically, and for domestically produced vaccines to meet 100% of the needs for expanded immunization programs and 30% of the needs for private immunization services. By 2045, Vietnam aims to be self-sufficient in producing specialized drugs, new drugs, original branded drugs, vaccines, biological products, and raw materials, with the goal of contributing over US$20 billion to GDP.

Law No. 44/2024/QH15, amending and supplementing several articles of the 2016 Pharmaceutical Law, has added provisions aimed at attracting investment, promoting research and development, and transferring pharmaceutical manufacturing technology. This law stipulates special investment incentives for projects with a total investment capital of VND 3,000 billion or more, with a minimum disbursement of VND 1,000 billion over three years, focusing on research and development of technology, production, or technology transfer for the production of pharmaceutical substances, new drugs, original branded drugs, rare drugs, the first domestically produced generic drugs, high-tech drugs, vaccines, and biological products.

In addition, the Ministry of Health is also urgently submitting to the Government a Decree guiding the Law on Pharmaceuticals, which will add investment projects in the development of the pharmaceutical industry to the list of specially prioritized investment sectors and professions, in order to enjoy preferential treatment regarding corporate income tax and land rent. The Decree will also specify policies on price maintenance and price reduction for new drugs, original branded drugs, high-tech drugs, vaccines, rare drugs whose production technology is transferred in Vietnam, and simplify import and export procedures for drugs and drug raw materials.

In addition, the Ministry of Health is also finalizing circulars guiding the Law on Pharmaceuticals and the Decree, expected to take effect from July 1, 2025, in order to reduce and simplify many administrative procedures related to GMP assessment and the issuance of drug and pharmaceutical raw material registration certificates.

In the coming period, the pharmaceutical industry will focus on implementing the following directions to promote the development of biopharmaceutical technology in Vietnam: Continuing to improve the legal framework and supplementing investment incentives to strongly attract domestic and foreign organizations/individuals to invest in research, transfer, and application of biotechnology in drug production; effectively implementing the National Strategy for the Development of the Vietnamese Pharmaceutical Industry, the Program for the Development of the Pharmaceutical and Medicinal Herb Industry, and the Program for Ensuring the Supply of Vaccines; developing concentrated industrial zones, prioritizing the biopharmaceutical industrial zone in Thai Binh and the High-Tech Pharmaceutical and Medical Zone in Ho Chi Minh City; focusing on ensuring the supply of drugs and drug raw materials, especially for rare and limited-supply drugs; strengthening drug quality management, inspection, handling of violations, and planning a nationwide testing system; improving the drug price management mechanism to stabilize the pharmaceutical market. Strengthen inspection and post-inspection to ensure people have access to quality, effective, and affordable medicines; promote international cooperation and boost exports of medicines and cosmetics; enhance training and improve the capacity of officials and experts; maintain NRA level 3 for vaccines and coordinate to expand NRA achievement to all medicines; promote administrative reform, digital transformation, and the application of artificial intelligence in the pharmaceutical industry.

Priority areas for attracting investment and technology transfer include: Production of pharmaceuticals, vaccines, biological products, branded drugs, high-tech drugs, specialized drugs, patented drugs, and pharmaceutical raw materials; scientific research on pharmaceutical technology and biotechnology for the production of new drugs, patented drugs, and raw materials from domestic medicinal plants and biological materials; and the development of the vaccine, biological product, and drug manufacturing industries whose patents or exclusive rights are about to expire.

The Deputy Minister of Health requested that the delegates focus their discussions on the following topics: assessing the current state of Vietnam’s biopharmaceutical industry, clarifying its strengths and weaknesses; the global and regional context, lessons learned, and policy adjustments from other countries; analyzing and clarifying the differences between Vietnam’s policies and those of other countries, along with the advantages and limitations of the proposed solutions; proposing specific policies and solutions to promote investment attraction and research and development in Vietnam’s biopharmaceutical industry; and recommendations to enhance Vietnam’s participation in global supply chains and its competitiveness internationally.

Within the framework of the conference, delegates presented papers on international experiences in basic research, clinical trials, and the production of biopharmaceutical products. These included presentations on policy trends for the development of the biopharmaceutical industry, plans for developing biotechnology capabilities, and the need for international cooperation.

The conference provided a relatively complete and accurate picture of the current state of the biopharmaceutical industry in Vietnam and the world. The Ministry of Health will synthesize, research, and propose appropriate and highly practical policies and solutions to develop the Vietnamese biopharmaceutical industry.

Ministry of Health

Source : https://suckhoecongdongonline.vn/