Decision No. 61/2007/QD-TTg on approving the "National Key Science and Technology Research Program for Developing Pharmaceutical Industry to 2020"

Pursuant to …;

Regarding the approval of the "National Key Science and Technology Research Program for the Development of Pharmaceutical Industry until 2020"

Pursuant to Decree No. 55/2003/NĐ-CP dated May 28, 2003 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Industry;

PRIME MINISTER

Pursuant to the Law on Organization of the Government dated December 25, 2001;

Pursuant to the Law on Science and Technology dated June 9, 2000;

Pursuant to Decree No. 81/2002/NĐ-CP dated October 17, 2002 of the Government detailing the implementation of certain provisions of the Law on Science and Technology;

Pursuant to Decision No. 207/2005/QĐ-TTg dated August 18, 2005 of the Prime Minister approving the Strategy for the Development of the Chemical Industry in Vietnam until 2010 (with consideration up to 2020);

Considering the proposal of the Minister of Industry,

Approves the "National Key Science and Technology Research Program for the Development of Pharmaceutical Industry until 2020" (hereinafter referred to as the Program) with the following main contents:

Pursuant to …;

Article 1. - Researching to create high-quality technologies domestically, combining with imports, mastering and applying advanced foreign technologies to produce pharmaceutical raw materials serving the pharmaceutical industry and drug manufacturing, aiming towards independent production of drugs domestically;

I. OBJECTIVES

1. General Objective:

- Researching to effectively exploit and utilize natural active substances extracted, synthesized, or semi-synthesized from valuable medicinal resources and natural resources of the country, serving the production of certain specialized drugs in Vietnam, meeting domestic medical needs and export requirements;

- Building and strengthening the material and technical infrastructure and human resource training capacity in the field of pharmaceutical chemistry, effectively serving scientific research, teaching, international cooperation, technology transfer, and application in production in this field;

- Bringing the science and technology of pharmaceutical chemistry in the country to a level equivalent to that of advanced countries in the region, and in some key areas reaching the level of developed countries worldwide;

- Contributing to building and developing the pharmaceutical chemical industry to independently produce and supply pharmaceutical raw materials for the development of the domestic drug manufacturing industry and the pharmaceutical industry in Vietnam.

2. Specific objectives for each stage:

a) From now until 2010:

- Researching to create advanced technologies suitable for domestic production conditions, implementing pilot-scale production of pharmaceutical products, intensifying the transfer and application of new technologies in production, combining with importing, mastering, and using advanced foreign technologies to produce pharmaceutical raw materials for drugs;

- Utilizing effectively the capabilities of the existing scientific and technological workforce and material and technical infrastructure in the field of pharmaceutical chemistry in the country. Building potential, investing deeply to upgrade the material and technical infrastructure of research institutes and universities, modernizing production technology chains and equipment in laboratories in the field of pharmaceutical chemistry; training a high-quality and highly skilled scientific and technological workforce, expanding international cooperation, meeting the needs of the development of the pharmaceutical chemical industry in the country;

- Contributing to building and developing the pharmaceutical chemical industry in Vietnam.

b) Stage 2011-2015:

- Concentrating resources, effectively implementing scientific and technological research tasks and international cooperation in the field of pharmaceutical chemistry during this critical period;

- Intensifying the production trial of products, transferring, receiving, mastering new technologies and products, and strongly applying them in production to create high-quality pharmaceutical raw materials serving the production of essential medicines domestically, contributing to the strong development of the pharmaceutical chemical industry in the country;

- Strengthening the potential in both material and technical infrastructure and human resource training, bringing the science and technology in the field of pharmaceutical chemistry in the country to a level equivalent to that of advanced countries in the region, and in some key areas reaching the level of developed countries worldwide.

c) Vision until 2020:

Researching and applying science and technology in the field of pharmaceutical chemistry in the country will reach advanced and modern levels, contributing to developing the pharmaceutical chemical industry into a leading economic and technical sector for producing and supplying sufficient raw materials for essential medicines, aiming towards independent production of drugs domestically.

1. Basic research, applied research, research and development (R&D), and pilot-scale product production serving the development of the pharmaceutical chemical industry:

1. Creating and developing high technology in agriculture

Field 1:

Inheriting and promoting previous scientific and technological research results to produce natural active substances from yellow flower sweet wormwood, mulberry flowers, green tea, papaya, etc. Extracting and semi-synthesizing the following major active substances to serve as raw materials for drug production: - Completing and commercializing the extraction technology of artemisinin to serve the production of antimalarial drugs, meeting domestic demand and participating in exports. Planning and developing regions for sweet wormwood cultivation, planting techniques, fertilization, and providing new high-yield seedlings;

- Creating regions for Madagascar periwinkle (Catharanthus roseus L.) cultivation in some coastal sandy areas in the North and Central regions. Researching the extraction of vinblastine, vincristine, vindoline, and catharantine from Madagascar periwinkle; semi-synthesizing vinblastine from vindoline and catharantine to serve as raw materials for cancer treatment drugs;

- Completing and commercializing the production technology of other high-value natural active substances such as beta-carotene, shikimic acid, polyphenols, troxerutin, palmatin, mangiferin, etc., to produce drugs domestically. Specific contents in Field 1: Content 1:

Researching the extraction of some natural active substances from Vietnamese herbs to serve as raw materials for drug and nutritional supplement production:

+ Studying the extraction process of sterols from soybeans;

+ Studying the semi-synthesis process of testosterone propionate from 16.DPA and soybean sterols as raw materials for hormone disease treatment drugs; + Studying the semi-synthesis process of oral contraceptive ethinylestradiol from estrone;

+ Studying the semi-synthesis process of DHEA from soybean sterols and 16.DPA.

+ Study the semi-synthesis process of testosterone propionate raw material for producing drugs to treat endocrine diseases from 16.DPA and soy sterols;

+ Study the semi-synthesis process of ethinylestradiol contraceptive drug from estrone;

+ Study the semi-synthesis process of DHEA from soy sterols, from 16.DPA.

- Expected results:

+ Extraction processes of sterols from soybeans and semi-synthesis of substances: testosterone propionate, ethinyl estradiol, DHEA.

Content 2: Study on extraction and purification of N-acetyl cysteine from animal horns, hooves, and hair to be used as raw materials for drug production:

+ Utilize waste products such as cattle horns, hooves, and hair to produce cystine;

+ Prepare and purify N-acetylcysteine to meet the standards of the Vietnamese Pharmacopoeia and British Pharmacopoeia for use as raw materials in the production of detoxifying drugs, expectorants, etc.;

- Expected results:

+ Cystine for the production of beauty and skin protection drugs;

+ N-acetylcysteine with an annual capacity of 100 kg.

Content 3: Study on extraction of glucosamine sulfate from shrimp shells as raw material for the production of arthritis treatment drugs:

+ Research and develop technological processes for extracting glucosamine from shrimp shell waste;

+ Research and develop technological processes for converting glucosamine into glucosamine sulfate;

+ Design a pilot-scale production line for extracting glucosamine and converting it into glucosamine sulfate.

- Expected results:

+ Technological process for producing glucosamine at pilot scale;

+ Technological process for converting glucosamine into glucosamine sulfate at pilot scale.

Content 4: Study to improve technology for extracting, semi-synthesizing, and commercializing artemisinin products from sweet wormwood (Artemisia annua) and its derivatives for use as raw materials in the production of malaria prevention, control, and treatment drugs, meeting domestic demand and serving exports:

+ Research new technologies to replace industrial gasoline-based extraction methods for artemisinin, increasing product recovery efficiency;

+ Research, design, manufacture, and install new technological lines meeting GMP standards with an annual capacity of 200 tons of artemisinin to increase extraction efficiency from 40% to 65%, while minimizing potential risks and hazards during extraction;

+ Select and rapidly propagate high-yield and quality sweet wormwood varieties to meet the seedling needs for concentrated planting areas;

- Expected results:

+ Develop new extraction technology for artemisinin achieving a recovery rate up to 65%;

+ New technological lines with an annual capacity of 200 tons of artemisinin, meeting GMP standards and some derivatives;

+ Plan and develop concentrated planting areas of high-yield and quality sweet wormwood.

Content 5: Production of carotenoid active ingredients for anti-aging and anti-cancer drugs from bitter gourd and marigold flowers:

+ Organize large-scale propagation and cultivation of high-quality bitter gourd and marigold plants with high carotenoid content in Luong Son District, Hoa Binh Province;

+ Produce carotenoid active ingredients as raw materials for the preparation of viga, vicuva, and vicuga drugs;

+ Research on extracting lutein and zeaxanthin from marigold flowers as raw materials for the preparation of vicuva drugs.

- Expected results:

+ Production processes and lines for carotenoids, lutein, and zeaxanthin.

Content 6: Production of L-rotundin and L-rotundin sulfate from Stephania rotunda roots and D,L-rotundin sulfate from palmatin hydrochloride extracted from Fibraurea tinctoria:

+ Research on concentrated planting of Stephania rotunda roots to ensure a stable supply of raw materials for extraction technology;

+ Improve methods and modernize equipment for extraction to enhance efficiency and quality of rotundin. Establish an extraction line with an annual capacity of 1,000 kg of rotundin;

+ Extract palmatin hydrochloride from Fibraurea tinctoria, a wild medicinal plant abundant in Vietnam. Establish a modern extraction line with an annual capacity of 1,000 kg of palmatin hydrochloride;

+ Research and establish a semi-synthesis process for D,L-rotundin sulfate from palmatin hydrochloride with an annual capacity of 500 kg;

+ Produce L-rotundin sulfate as raw material for injectable drug formulation with an annual capacity of 100 kg.

- Expected results:

+ Complete extraction processes for L-rotundin and palmatin hydrochloride; semi-synthesis process for D,L-rotundin sulfate; preparation process for L-rotundin sulfate; planting process for Stephania rotunda roots on a large scale of 1 hectare.

Content 7: Improve the technological process for extracting glycosides from bitter melon to produce functional food that reduces blood sugar levels:

+ Improve the technological process; design and install equipment for extraction to conduct trial production of glycosides (with a daily capacity of 500 kg of raw material);

+ Improve the production process for functional food that reduces blood sugar levels, with a daily capacity of 200-300 kg.

- Expected results:

+ Technological processes for extracting glycosides from bitter melon and producing functional food at pilot scale;

+ Two products are glycoside powder and functional food that reduce blood sugar levels.

Content 8: Improve technology to produce marine products with high biological activity for use in the pharmaceutical and food industries:

+ Investigate, evaluate, and determine sources of marine biological raw materials in Vietnam for the extraction and isolation of highly bioactive polyunsaturated fatty acids (PUFAs);

+ Optimize laboratory-scale production processes for PUFA formulations; establish pilot-scale production processes for large quantities of PUFA formulations with a batch capacity of 300-500 kg and test them in the pharmaceutical and food industries.

- Expected results:

+ Optimized technological processes for trial production of PUFA formulations;

+ Research results on the safety and efficacy of PUFA formulations.

Field 2: Raw materials for antibiotics:

- Research and understand modern antibiotic synthesis processes to provide consulting services for investment projects in antibiotic manufacturing plant construction;

- Research and improve biotransformation processes of cephalosporin C to 7.ACA, synthesis of two side chains of cefepime, and semi-synthesis of cefepime hydrochloride to meet international quality standards;

- Research on the synthesis of intermediate products as raw materials for domestic antibiotic production.

Some specific contents in field 2:

+ Studying the semi-synthesis process of testosterone propionate from 16.DPA and soybean sterols as raw materials for hormone disease treatment drugs; Research on the preparation of fourth-generation semi-synthetic cephalosporin antibiotic cefepime hydrochloride:

+ Research on improving and perfecting the biosynthesis processes of cephalosporin C and CA in 80-liter fermenters;

+ Research on improving and perfecting the biotransformation process of cephalosporin C to 7.ACA;

Conduct comprehensive synthesis research on two auxiliary pathways of cefepim and achieve international standards for the semi-synthesis of cefepim hydrochloride.

- Expected results:

Develop production processes for cephalosporins and intermediate products for antibiotic manufacturing.

Content 2: Establish technology for producing raw materials to formulate certain first-generation cephalosporin antibiotics at pilot scale:

+ Construct a pilot plant for antibiotic production testing with a capacity of 5 kg/batch;

+ Test-produce cefalexin for oral use and cefradine for injection.

- Expected results:

+ Pilot plant and test-production technology for antibiotics with a capacity of 5 kg/batch;

+ Produce 200 kg of cefalexin meeting British Pharmacopoeia 2005 standards;

+ Produce 100 kg of cefradine meeting British Pharmacopoeia 2005 standards.

Field 3: Raw materials for vitamin production:

Research technological processes for producing sorbitol from glucose; new advanced technologies for trial production of vitamins: C, E, A, B, K, PP...

Some specific contents in field 3:

+ Studying the semi-synthesis process of testosterone propionate from 16.DPA and soybean sterols as raw materials for hormone disease treatment drugs; Research new technology to create raw materials for vitamin C production:

+ Survey various strains of acetobacter and pseudomonas for converting sorbitol into 2-ketogulonic acid;

+ Investigate the esterification reaction of 2-ketogulonic acid;

+ Investigate the enolization and lactonization reactions, and refine to produce vitamin C.

- Expected results:

+ Technological process for producing raw materials to formulate vitamin C meeting British Pharmacopoeia 2003 standards.

Content 2: Research to improve the technological process for producing sorbitol from glucose:

+ Research selection of raw materials, processing conditions, and improvement of the technological process;

+ Research methods for product recovery and preservation;

+ Application in the processing of some confectionery and ice cream products.

- Expected results:

+ Technological process for producing sorbitol from glucose;

+ Pilot production line for sorbitol with a capacity of 100 tons/year.

Field 4: Modification of starch and cellulose as excipients and other products for pharmaceuticals and food industries:

- Research to improve the technological process of modifying starch and cellulose, creating products that meet pharmaceutical and food industry standards. Transfer and apply this production technology to pharmaceutical and food factories;

- Develop technological processes for producing functional sugars: maltitol, palatinose, and hydrolyzed starch syrup;

- Research technological processes and equipment for producing functional sugars maltitol, palatinose, and hydrolyzed starch syrup from cassava starch;

- Research production technology for some additives from domestic raw materials (pharmaceutical colorants, film-coated tablets, etc.).

Some specific contents in field 4:

Content 1: Implementing the technology for producing carboxymethyl starch meeting pharmaceutical and functional food industry standards from domestic raw materials:

+ Research processing technology for starch to meet modification standards;

+ Determine optimal parameters of the technological process to produce products suitable for the pharmaceutical and functional food industries;

+ Trial production of the product using laboratory equipment in small quantities;

+ Establish a production line and conduct pilot-scale trial production;

+ Transfer and apply this production technology to pharmaceutical and food factories.

- Expected results:

+ Technological process for producing modified starch from cassava starch;

+ Carboxymethyl starch product meeting pharmaceutical and functional food standards;

+ Successfully transfer this production technology to food and pharmaceutical factories.

Content 2: Establish a chemical modification starch production process with a capacity of 1,000 tons/year and apply it in the pharmaceutical and functional food industries:

+ Research starch modification using acid method;

+ Study the effects of HCl concentration, temperature, time, water-to-starch ratio, etc., on the properties of the resulting product (molecular weight, solubility, suspension stability, etc.);

+ Develop a technological process for producing modified starch using dilute HCl;

+ Research starch modification using oxidation method;

+ Study the influence of physical and chemical factors on the degree of conversion and molecular weight of the modified starch product;

+ Research the most effective and thorough sodium hypochlorite removal process;₂SO₃ + Study the impact of different factors on the formation of carboxyl, aldehyde, and ketone groups on the starch molecule during modification;

+ Design, manufacture, and establish a technological process for producing modified starch using sodium hypochlorite;

+ Research the application of modified starch in the pharmaceutical and food industries (as excipient for tablets, candy, instant noodles, etc.) and other fields.

+ Technological process for producing modified starch using chemical methods with a capacity of 1,000 tons/year.

- Expected results:

Establish a technological process for producing functional sugars from cassava starch for use in the pharmaceutical industry:

Content 3: + Develop a technological process and equipment for producing maltitol from cassava starch;

+ Develop a technological process and equipment for producing palatinose from cassava starch;

+ Develop a technological process and equipment for producing functional sugar, hydrolyzed starch syrup from cassava starch.

+ Technological process and production line for maltitol;

- Expected results:

+ Technological process and production line for palatinose;

+ Technological process and production line for hydrolyzed starch syrup.

Complete the technological process for producing fructooligosaccharides (FOS) from sucrose:

Content 4: + Improve the technological process for producing FOS at pilot scale with a capacity of 300 liters/batch;

+ Design, fabricate, and install a pilot-scale production line for FOS with a capacity of 300 liters/batch;

+ Organize trial production of FOS using the above production line.

+ Technological process for producing FOS at pilot scale;

- Expected results:

+ Production line for FOS with a capacity of 300 kg/batch;

+ Produce liquid and powdered FOS meeting the quality standards of imported products.

Field 5:

Field 5: Raw materials for producing drugs to treat cancer, cardiovascular diseases, organ rejection, HIV/AIDS, drug addiction, and other essential medicines:

- Develop advanced technological processes for synthesizing and purifying raw materials for producing cancer treatment drugs;

- Research on synthesizing and testing propranolol as raw material for producing drugs to treat angina pectoris;

- Research on synthesizing and testing nifedipine as raw material for producing drugs to treat hypertension (HTN);

- Research on developing synthesis processes for azathioprine, raw material for producing drugs to treat immunodeficiency diseases;

- Research on synthesizing zidovudine (AZT), nevirapine (NVP), raw materials for producing drugs to inhibit HIV/AIDS transmission from mother to child;

- Research on perfecting technology for producing paracetamol, raw material for producing fever-reducing and pain-relieving drugs.

Some specific contents in field 5:

+ Studying the semi-synthesis process of testosterone propionate from 16.DPA and soybean sterols as raw materials for hormone disease treatment drugs; Research on producing some chemical raw materials for treating cancer:

+ Research on technological processes for synthesizing and purifying chemical raw materials for producing cancer treatment drugs;

+ Determine the structure and purity of chemical raw materials using physical methods;

+ Collaborate with the pharmaceutical industry to produce and test cancer drugs according to the British Pharmacopoeia 2005;

- Expected results:

+ Technological process for producing chemical raw materials for treating colorectal cancer (5-fluorouracil), breast cancer (taxol), and non-small cell lung cancer, raw material for producing cisplatin;

Content 2: Research on synthesizing, purifying, and testing nifedipine as medicine for treating hypertension:

+ Research on technological processes for synthesizing and purifying nifedipine;

+ Determine the structure and purity of nifedipine;

+ Test nifedipine according to the British Pharmacopoeia 2003;

- Expected results:

+ Technological process for synthesizing and purifying nifedipine with international standards of purity;

Content 3: Research on synthesizing, purifying, and testing propranolol as raw material for producing drugs to treat angina pectoris:

+ Research on technological processes for synthesizing and purifying propranolol;

+ Determine the chemical structure and purity of propranolol;

+ Test propranolol according to the British Pharmacopoeia 2005;

- Expected results:

+ Synthesis and purification process for propranolol with international standards of purity;

Content 4: Research on technological processes for synthesizing azathioprine as raw material for producing drugs to treat immunodeficiency diseases:

+ Research on synthesizing azathioprine from thiourea;

+ Test azathioprine according to the British Pharmacopoeia 2005;

- Expected results:

+ Technological process for synthesizing and purifying azathioprine according to the British Pharmacopoeia 2005;

Content 5: Research on synthesizing, purifying, and testing the dual drug zidovudine (AZT) - nevirapine (NVP), raw material for producing drugs to inhibit HIV/AIDS transmission from mother to child:

+ Research on technological processes for synthesizing and purifying AZT - NVP;

+ Determine the chemical structure and purity of AZT - NVP;

+ Test AZT - NVP according to the British Pharmacopoeia 2003;

- Expected results:

+ Technological process for synthesizing and purifying AZT - NVP with international standards of purity;

Content 6: Research on producing methadone active ingredient for drug rehabilitation from drug addiction:

+ Research on technological processes for synthesizing, testing, and trial production of methadone formulations for opioid drug addiction rehabilitation;

+ Design a production line with a capacity of 0.5 kg/batch and trial produce 10 kg of formulations;

- Expected results:

Technological process for synthesizing methadone with stable technical parameters; pilot-scale production line equipment for methadone;

Content 7: Perfecting technology for producing biological active ingredients from Madagascar periwinkle (Catharanthus roseus L.):

+ Perfecting technology for extracting vinblastine, vincristine, vindoline, catharanthine, and ajmalicine at pilot scale;

+ Promote trade to export vindoline and catharanthine active ingredients;

- Expected results:

Technological process for extracting vinblastine, vincristine, vindoline, catharanthine, and ajmalicine at pilot scale; establish concentrated raw material plantations of Madagascar periwinkle;

During the implementation of the Program, the list of fields, contents, topics, projects, and research tasks in the chemical drug sector above may be reviewed, adjusted, and supplemented by the Inter-ministerial Steering Committee of the Program to suit the actual conditions of each stage;

The Inter-ministerial Steering Committee of the Program is responsible for selecting, organizing the implementation of contents, tasks, topics, and projects; evaluating and accepting the results of implementation; organizing the transfer and application of chemical drug raw material production technologies created by the Program to chemical drug factories and enterprises in accordance with current state regulations on science and technology management;

2. Building potential for scientific and technological research to serve the development of the chemical drug industry:

a) Investing deeply to build technical infrastructure, upgrading and modernizing specialized chemical laboratory systems:

- Invest deeply to upgrade and modernize research institutes, universities, and chemical laboratories to enhance research and technological capabilities in the chemical drug industry;

- Construct new chemical laboratories equipped with advanced and synchronized machinery and equipment, reaching regional levels, with some key chemical laboratories achieving world-leading country standards;

- Establish and operate a national database system and a website on the chemical drug industry, ensuring timely and comprehensive information sharing among agencies and personnel working in this field;

b) Training human resources:

- Train new and retrain scientific and technological staff and managers at domestic and foreign universities to meet the quality requirements for human resources needed for the development of the chemical drug industry in our country;

- Train technical workers at vocational schools to implement Program contents in enterprises and localities;

- By 2010, train 50-60 PhDs, 200-300 Masters, 300-500 technicians, and retrain 50 scientific and technological staff with bachelor's degree or higher qualifications.

3. International cooperation in the pharmaceutical industry sector:

- Implement research topics and projects in collaboration with foreign countries, organizations, and individuals, as well as overseas Vietnamese scientists to rapidly and strongly develop the domestic pharmaceutical industry;

- Import, master, and effectively apply new, advanced technologies from abroad to produce chemical raw materials for the sustainable development of the domestic drug manufacturing industry.

4. Contribute to the construction and development of the pharmaceutical industry:

- Vigorously apply scientific research results, proactively transfer technologies, technical advancements, chemical raw material products, and new, advanced production lines created by the Program into production, making substantial contributions to the construction and development of the domestic pharmaceutical industry;

- Closely coordinate with the health sector, particularly the pharmaceutical industry, to effectively and timely implement tasks for developing the pharmaceutical industry as stipulated in Decision No. 43/2007/QD-TTg dated March 29, 2007 of the Prime Minister on approving the "Program for Developing the Pharmaceutical Industry and Building a Drug Supply System Model in Vietnam for the Period 2007-2015 with Vision to 2020";

- Propose to competent authorities for consideration and issuance of mechanisms and policies encouraging scientific and technological organizations, enterprises, and individuals to invest in technology transfer, reception, mastery, and application for producing chemical raw materials for drugs, as well as marketing, trade promotion, and brand promotion activities for chemical drug products.

III. MAJOR SOLUTIONS

1. Strengthen and diversify investment sources to effectively and timely implement the Program's contents:

a) The total budget for implementing the Program is determined based on the budgets of each research topic, project, and specific task approved by competent authorities. Annually, the State will gradually increase investment funds from the state budget while diversifying other resources to effectively and timely implement the Program's contents;

b) The total state budget for the first five years of implementing the Program's contents is estimated at approximately 500 billion VND, including 300 billion VND for implementing tasks such as basic research, applied research, research and development (R-D), supporting pilot-scale product production, human resource training, international cooperation, and supporting technology transfer projects and production of key chemical drug products; 200 billion VND for deep investment to upgrade, modernize, and build new specialized chemical drug laboratories;

c) Funds for constructing factories to produce chemical raw materials for drug manufacturing are the responsibility of enterprises.

2. Promote scientific research, technology transfer, and application in chemical raw material production to contribute to the development of the pharmaceutical industry; build strong scientific and technological capacity in the chemical drug field:

- Vigorously promote scientific research, technology transfer, and application of new, advanced technologies and production lines of the Program for chemical drug factories to produce chemical raw materials on an industrial scale for effective service to the domestic drug manufacturing industry; expand product promotion, marketing, and commercialization activities for chemical raw materials, contributing substantially to the construction and development of the domestic pharmaceutical industry;

- Strengthen and diversify investment sources to upgrade and modernize the technical infrastructure of research institutes and universities, establish and operate advanced, modern, and integrated chemical drug laboratories effectively, and train sufficient high-quality human resources to meet the needs of scientific and technological research in the chemical drug field and contribute to the development of the domestic pharmaceutical industry.

3. Expand and strengthen international cooperation in the chemical drug field:

Expand and strengthen bilateral and multilateral international cooperation with foreign countries, organizations, and individuals in the chemical drug field. Proactively build and implement international cooperation programs, topics, and projects, especially with countries having advanced pharmaceutical industries, to seek assistance in experience, intellectual resources, financial resources, and attract investment to rapidly, strongly, and sustainably develop scientific and technological capabilities in the chemical drug field and the domestic pharmaceutical industry.

4. Improve the establishment of systems of mechanisms, policies, and regulatory legal documents to serve the development of scientific and technological capabilities in the chemical drug field:

Improve the establishment and issuance of systems of mechanisms, policies, and regulatory legal documents to serve the development of scientific and technological capabilities in the chemical drug field. Research institutes, universities, enterprises, scientists, entrepreneurs, and individuals involved in activities aimed at developing scientific and technological capabilities in the chemical drug field and the pharmaceutical industry shall enjoy the highest preferential policies regarding loans, credit, tax rates, land use rights, stimulus policies, and other related policies according to current state regulations.

IV. IMPLEMENTATION

1. Ministry of Industry:

- Take the lead and coordinate with the Ministry of Health, the Ministry of Science and Technology, relevant ministries, localities, and agencies to effectively and timely implement the contents of the "National Key Scientific and Technological Research Program for Developing the Pharmaceutical Industry until 2020", and report the results annually to the Prime Minister;

The Minister of Industry shall establish an inter-ministerial steering committee to organize the implementation of the "National Key Program for Developing the Pharmaceutical Industry until 2020" with the Minister of Industry serving as the Chairman. The composition and operational rules of the inter-ministerial steering committee and its office (located at the Department of Science and Technology) shall be decided by the Minister of Industry serving as the Chairman of the inter-ministerial steering committee.

- Coordinate with the Ministry of Health, relevant ministries, sectors, and localities to effectively implement and adhere to the schedule of tasks for developing the pharmaceutical industry as set out in Decision No. 43/2007/QĐ-TTg dated March 29, 2007, of the Government on approving the Project "Developing the Pharmaceutical Industry and Building a Model Supply System for Medicines in Vietnam for the period 2007-2015 and Vision to 2020".

2. The Ministry of Health:

- Coordinate with the Ministry of Industry to effectively implement, adhere to the schedule of the assigned contents, tasks, research topics, and projects, particularly the effective application of research results on chemical raw materials from the Program to develop the pharmaceutical industry in Vietnam.

- Take the lead and coordinate with relevant ministries, sectors, and localities to build and develop the pharmaceutical formulation industry and the pharmaceutical industry in Vietnam.

3. The Ministry of Science and Technology: based on their functions, tasks, authorities, and scope of state management, coordinate with the Ministry of Industry in selecting; organizing the implementation of contents, tasks, research topics, and projects; evaluating and accepting the results of implementation; organizing the transfer and application of technologies generated by the Program for chemical drug factories to produce domestic drug ingredients.

4. The Ministry of Education and Training: take the lead and coordinate with the Ministry of Industry and the Ministry of Health to organize training high-quality human resources to meet the needs of scientific and technological research in the field of chemicals and the development of the chemical industry in Vietnam.

5. The Ministry of Planning and Investment, the Ministry of Finance, the Ministry of Science and Technology: balance, allocate, and guide the use of capital to effectively implement and adhere to the schedule of the Program's contents, tasks, research topics, and projects approved by competent authorities.

6. Other relevant ministries, sectors, localities, organizations, and individuals: if they wish to participate in implementing the Program's contents, tasks, research topics, and projects, they should register with the Ministry of Industry and the Inter-Ministerial Steering Committee for consideration and resolution. 

Article 2. This Decision takes effect fifteen days after its publication in the Official Gazette.

The Minister of Industry, ministers, heads of ministerial-level agencies, heads of government-affiliated agencies, Chairmen of provincial and municipal People's Committees directly under the central government, and related organizations and individuals are responsible for enforcing this Decision.