Decision No. 270/QD-TTg dated February 13, 2025 on approving the development program for medicinal chemistry industry by 2030 with a vision towards 2045

DECISION

APPROVING THE DEVELOPMENT PROGRAM FOR MEDICINAL CHEMISTRY INDUSTRY BY 2030 WITH A VISION TOWARDS 2045

THE PRIME MINISTER

Pursuant to the Law on Government Organization dated June 19, 2015; the Law on amendment to some articles of the Law on Government Organization and the Law on Local Government Organization dated November 22, 2019;

Pursuant to the Law on Pharmacy dated April 06, 2016; the Law on amendments to some articles of the Law on Pharmacy No. 44/2024/QH15 dated November 21, 2024;

Pursuant to Resolution 29-NQ/TW dated November 17, 2022 of the National Assembly on the 6^th plenum of the 13^th Central Committee of the Communist Party of Vietnam on promotion of industrialization and modernization of Vietnam by 2030 with a vision towards 2045;

Pursuant to Resolution No. 36-NQ/TW dated January 30, 2023 of the Politburo on development and application of biological technology to serve the sustainable development of Vietnam in the new situation;

Pursuant to Directive No. 03-CT/TW dated May 19, 2021 of the Secretariat on promotion of the leadership of the Party over the movement "Vietnamese prioritize using Vietnamese products" in the new situation;

Pursuant to Decision No. 61/2007/QD-TTg dated May 07, 2007 of the Prime Minister approving "National key scientific and technological research program on pharmaceuticals by 2020”;

Pursuant to Decision No. 376/QD-TTg dated March 17, 2021 of the Prime Minister approving “Development program for pharmaceuticals industry and domestically produced herbal ingredient until 2030 and vision to 2045”;

Pursuant to Decision No. 726/QD-TTg dated June 16, 2022 of the Prime Minister approving “Vietnam’s chemical industry development strategy by 2030 with a vision towards 2040”;

Pursuant to Decision No. 165/QD-TTg dated February 28, 2023 of the Prime Minister approving “Scheme for restructuring the industry and trade sector by 2030”;

Pursuant to Decision No. 1165/QD-TTg dated October 09, 2023 of the Prime Minister approving “National strategy for Vietnam’s pharmaceutical industry development by 2020 with a vision towards 2045”;

At the request of the Minister of Industry and Trade.

HEREBY DECIDES:

Article 1. The Development Program for medicinal chemistry industry by 2030 with a vision towards 2045 (hereinafter referred to as “the Program”) is approved. To be specific:

I. DEVELOPMENT VIEWPOINTS

1. Prioritize developing medicinal chemistry as an economic industry with high value-added, with the ability to deeply engage in the production network and value chain of the global pharmaceutical and chemical industry, with a high spillover impact on other economic industries.

2. Promote development of Vietnamese medicinal chemistry products as well as the planning and investment in development of regions having herbal ingredients to formulate value chains in the pharmaceutical industry.

3. Attract investment from domestic enterprises and multinational pharmaceutical corporations to develop medicinal chemistry industry of Vietnam, with a focus on directing multinational pharmaceutical corporations to invest in manufacturing medicinal chemistry products by chemical synthesis method, and domestic enterprises to invest in producing natural medicinal chemistry products.

II. OBJECTIVES

Develop medicinal chemistry industry; gradually increase the production and use of domestic pharmaceutical raw materials and promote the export of medicinal chemistry products; contribute to complete the Vietnam’s chemical industry development strategy, Development program for pharmaceuticals industry and domestically produced herbal ingredient and National strategy for Vietnam’s pharmaceutical industry development by 2020 with a vision towards 2045 approved by the Prime Minister with the following specific objectives:

1. By 2030:

- Strive to fulfill 20% of the raw material demand for medicine production and 50% of the raw material demand for domestic production of functional foods and cosmeceuticals.

- The export growth rate of some natural medicinal chemistry products (active ingredients, standardized extracts, essential oils with active ingredients) reaches at least 10% per year.

2. Vision towards 2045:

- Vietnam's medicinal chemistry industry becomes a high-tech, modern, competitive industry and participates in the global pharmaceutical value chain.

- The industrial production growth rate of the medicinal chemistry industry reaches 8-11% per year.

III. MAJOR TASKS AND SOLUTIONS

1. Regarding regulations and laws

a) Research, review, and improve mechanisms, policies, regulations on incentives, supports and attraction for investment in development of medicinal chemistry industry including the most favorable incentives in terms of taxes, land, finances, etc., for activities such as research and development, production investment, technology transfer, especially new technologies, core technologies, and the technologies for production of high-quality, high-value medicinal chemistry products. Attract domestic enterprises and multinational pharmaceutical corporations to develop the production of medicinal chemistry products by chemical synthesis and biochemical synthesis. Encourage, support Vietnamese enterprises to invest in extraction and refinement of natural medicinal chemistry products with the value chain from cultivation, care, harvesting, primary processing of herbal ingredients to production and distribution of the products.

Review, issue policies on investment incentives for production of essential chemical raw materials such as basic chemicals, petrochemicals to serve medicinal chemistry synthesis, and extraction and refinement of herbal ingredients (used for medicinal chemistry synthesis and extraction and refinement of herbal ingredients);

b) Improve and update Vietnamese standards, technical regulations related to medicinal chemistry products;

c) Review, adjust, and simplify administrative procedures for investment, production, business, trade promotion, export, international cooperation in medicinal chemistry industry. Support organizations and individuals to register the inventions, register for the protection of intellectual property rights of new medicinal chemistry products; register for domestic circulation, support clinical trials for medicines formulated from domestic medicinal chemistry products.

2. Regarding science –technology, human resources and training

a) Promote research and development activities, and technology transfer in medicinal chemistry with a focus on researching, developing, and implementing a number of national and ministerial scientific and technological tasks to develop high-quality medicinal chemistry products that can replace imported products;

b) Encourage pharmaceutical and medicinal chemistry enterprises to optimize their income to establish a science and technology development fund of the enterprise in accordance with the law;

c) Promote training, ensure sufficient human resources for medicinal chemistry industry, and focus on training high-quality human resources. Promote domestic and international cooperation activities, cooperation between enterprises and higher education institutions, research facilities in human resources training;

d) Support, provide favorable conditions to attract experienced foreign experts, scientists, managers, and overseas Vietnamese to work in the medicinal chemistry industry in Vietnam.

3. Measures for international cooperation

a) Actively participate in international conferences and organizations related to medicinal chemistry. Promote research activities, workshops, exchanging research results, and technology transfer with countries that have a developed medicinal chemistry industry.

b) Leverage the advantages of Free Trade Agreements that Vietnam has joined to enhance the effectiveness of attracting investment for the development and production of medicinal chemistry products, supporting the protection of domestic medicinal chemistry production.

4. Measures for trade promotion, information and communication

a) Encourage and facilitate for domestic enterprises to expand cooperation, joint ventures, and partnerships with foreign partner to broaden markets, promote products, and enhance the brand of Vietnamese goods;

b) Implement specific measures to promote and build the image and national brand, as well as the quality of high-economic-value medicinal chemistry products. Research and promote the development of certain medicinal chemistry products as national products. Enhance dissemination to encourage the use of domestic medicinal chemistry products;

c) Research and develop branding programs for some representative medicinal chemistry products.

5. Measures for finance and investment

a) Attract investment resources from both domestic and foreign enterprises, focus on drawing investment from large multinational corporations and enterprises; encourage and facilitate enterprises to invest in research and development of medicinal chemistry products.

b) Comply with the laws regarding the state budget allocated for the tasks and projects of the Program;

c) Research, review, supplement, and effectively utilize resources from the National Technology Innovation Foundation and the National Foundation for Science and Technology Development to support research, implementation, technology transfer, and application of new technologies in the production and development of medicinal chemistry products, biosynthesis of medicinal chemistry products, and extraction and refinement of medicinal chemistry products from herbal ingredients;

d) Orient investment attraction and facilitate enterprises to invest in establishing high-tech zones and industrial parks specialized in medicinal chemistry in conformity with approved plans.

6. The list of National key development projects for medicinal chemistry industry requesting for investment is prescribed in the Appendix attached to this Decision.

Article 2. Implementation

1. The Ministry of Industry and Trade shall:

a) Take charge of the implementation of the Program; supervise, consolidate the situation and results of the implementation of the Program nationwide, and report to the Prime Minister annually;

b) Cooperate with the Ministry of Health, relevant ministries and authorities to promote the use of domestic medicinal chemistry products to support the development of the medicinal chemistry industry according to the National strategy for Vietnam’s pharmaceutical industry development by 2020 with a vision towards 2045, Development program for pharmaceuticals industry and domestically produced herbal ingredient until 2030 and vision to 2045 approved by the Prime Minister;

c) Cooperate with the Ministry of Science and Technology to propose key researching tasks in the Program for research, application, and development of advanced technology to serve the medicinal chemistry and pharmaceutical industry according to commission mechanisms;

d) Cooperate with the Ministry of Planning and Investment, Ministry of Finance and relevant ministries, authorities to propose mechanisms, policies on investment incentives to attract domestic and foreign investment projects from multinational corporations in medicinal chemistry industry;

dd) Take charge in research and development of branding programs with at least five representative medicinal chemistry products; cooperate with relevant ministries and authorities to promote trade promotion for medicinal chemistry products;

e) Take charge in formulation of the plan and cooperation between Ministry of Industry and Trade and the following ministries to implement this Program: Ministry of Health, Ministry of Science and Technology, Ministry of Agriculture and Rural Development.

2. The Ministry of Health shall:

a) Take lead in using domestic medicinal chemistry products to produce medicines; closely cooperate with the Ministry of Industry and Trade to determine requests, targets of the medicinal chemistry products to support domestic medicine production activities;

b) Direct the development of regions having herbal ingredients according to the Development program for pharmaceuticals industry and domestically produced herbal ingredient approved by the Prime Minister;

c) Take charge in adjustment and simplification of administrative procedures for registration for circulation of medicinal chemistry products used for medicine production.

3. The Ministry of Science and Technology shall:

a) Promote the implementation of the Program for research, application, and development of advanced technology to serve the medicinal chemistry and pharmaceutical industry to carry out the tasks and solutions of the Program;

b) Direct the use of National Technology Innovation Foundation and the National Foundation for Science and Technology Development for research, implementation, technology transfer, application of new technologies in production, development of synthetic medicinal chemistry and biosynthetic medicinal chemistry products, and products from extraction and refinement of herbal ingredients;

c) Research, add medicinal chemistry synthesis technology in the List of high technologies prioritized for investment and development, and add synthetic medicinal chemistry products to the List of high-tech products encouraged for development;

d) Take charge and cooperate with the Ministry of Industry and Trade, Ministry of Health, relevant ministries and authorities to research, carry out national science and technology tasks to serve the medicinal chemistry industry; complete the system of Vietnamese standards and national technical regulations on medicinal chemistry in conformity with international standards.

4. The Minister of Agriculture and Rural Development shall:

Cooperate with the Ministry of Health, Ministry of Industry and Trade, relevant authorities, and People’s Committees of provinces and central-affiliated cities to plan and develop regions for cultivation of herbal ingredients to ensure a sufficient supply of raw materials for the medicinal chemistry industry.

5. The Ministry of Finance shall:

Cooperate with the Ministry of Industry and Trade, relevant ministries and authorities to direct and allocate funding from the state budget in accordance with the current state budget decentralization to implement the Program, ensure compliance with the laws on state budget and related laws.

6. The Ministry of Planning and Investment shall:

a) Take charge and cooperate with the Ministry of Industry and Trade to review, evaluate and propose mechanisms, policies on attraction and investment incentives in medicinal chemistry industry;

b) Cooperate with the Ministry of Industry and Trade, Ministry of Health and local authorities to promote investment attraction and establishment of high-tech zones and industrial parks specialized in medicinal chemistry; allocate and balance state budget funds to implement the Program's projects in accordance with the laws on public investment and related laws.

7. People’s Committees of provinces and central-affiliated cities shall:

a) Implement investment promotion activities for medicinal chemistry projects in provinces and cities; closely cooperate with the Ministry of Industry and Trade, the Ministry of Health, and related authorities to guide and facilitate administrative procedures, and adopt effective support measures to attract and promote investors and enterprises in implementing medicinal chemistry projects in provinces and cities;

b) Allocate land bank and provide infrastructure support for investment projects for development of medicinal chemistry industry in accordance with approved plans, the Program, and laws;

c) Formulate and issue mechanisms and policies tailored to local conditions to encourage investment, attract, and train human resources for the development of the medicinal chemistry industry.

Article 3. This Decision comes into force from the day on which it is signed.

Article 4. Ministers , Heads of ministerial authorities, Heads of governmental authorities, Presidents of People's Committees of provinces and central-affiliated cities, heads of relevant authorities are responsible to implement this Decision.

APPENDIX

THE LIST OF NATIONAL KEY DEVELOPMENT PROJECTS FOR MEDICINAL CHEMISTRY INDUSTRY REQUESTING FOR INVESTMENT
(Attached to Decision No. 270/QD-TTg dated February 13, 2025 of the Prime Minister)