DECISION

APPROVING NATIONAL STRATEGY FOR VIETNAM’S PHARMACEUTICAL INDUSTRY DEVELOPMENT BY 2020 WITH A VISION TOWARDS 2045

THE PRIME MINISTER

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

Pursuant to the Law on Pharmacy dated April 06, 2016;

Pursuant to the Resolution No. 20-NQ/TW dated October 25, 2017 of the 12^th Central Committee of Communist Party of Vietnam on enhancement of people’s health protection, improvement and care in new situation;

Pursuant to the Resolution No. 29-NQ/TW dated November 17, 2022 of the Central Committee continuing to accelerate the national industrialization and modernization by 2030 with a vision to 2045;

Pursuant to the Resolution No. 36-NQ/TW dated January 30, 2023 of the Poliburo on development and application of biotechnology in support of sustainable development of the country in the new situation;

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HEREBY DECIDES:

Article 1. The National Strategy for Vietnam’s Pharmaceutical Industry Development by 2020 with a vision towards 2045 (hereinafter referred to as “the Strategy”) is approved. To be specific:

I. DEVELOPMENT VIEWPOINTS

1. Ensure proactive and timely supply of quality, safe and effective drugs at reasonable costs to satisfy the needs for disease prevention and treatment, recovery from disasters, catastrophes and public health events and other urgent needs for drugs, and meet the requirements for socio-economic development and assurance about national defense and security.

2. Develop Vietnam’s pharmaceutical industry in a sustainable and modern way which attaches great importance to assurance about drug security; develop pharmaceuticals industry, pharmaceutical chemistry and domestically produced herbal materials, increase the export value and promote deep integration into the global pharmaceutical supply chain.

3. Vietnam’s pharmaceutical industry is a spear-headed industry which is given prioritized resources and incentives powerful enough for its development.

4. Develop a professional, modern, effective and properly managed drug production, distribution and supply system; improve the efficiency in drug supply and distribution by domestic enterprises in accordance with international commitments.

5. Make sure that drugs are used in a reasonable, safe and effective manner by employing synchronous measures, which focuses on promoting and improving the capacity for and efficiency in the conduct of clinical pharmacy and pharmacovigilance activities and building a pharmaceutical data ecosystem.

II. OBJECTIVES

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Develop Vietnam's pharmaceutical industry on a par with developed countries in the region, provide the people with access to drugs at reasonable costs; increase capability of conducting researches and applying available technology to produce original brand-name drugs and drugs having new and modern dosage forms, aiming to become a hub for manufacturing, processing/technology transfer of original brand-name drugs of the ASEAN region, striving to elevate its domestic pharmaceuticals industry to a WHO level 4 classification; develop herbal materials, drugs and products from domestic herbal materials so that the field involving the production of goods of high quality and value is formed; promote the production of medicinal materials; optimize the medication usage.

2. Specific objectives by 2030:

a) Strive to have 100% of drugs supplied in a proactive and timely manner in order to satisfy the needs for disease prevention and treatment; ensure drug security, meet the requirements for assurance about national defense and security, disease prevention and control, recovery from disasters, catastrophes and public health events and other urgent needs for drugs.

b) Domestically produced drugs are expected to meet about 80% of demand and 70% of market value.  Keep striving to achieve the goal of producing 20% of the raw materials needed for domestic drug production. Domestically produced vaccines are set to meet 100% of the demand for expanded immunization and 30% of the demand for immunization upon request.

c) Strive to become a high value pharmaceuticals production center in the region. Receive transferred technology or take charge of processing associated with transfer of technology for production of at least 100 original brand-name drugs, vaccines, biologicals, including biosimilars and certain drugs that Vietnam is unable to produce.

d) Build 08 areas for sustainable collection of natural herbal materials and 02 - 05 areas for large-scale cultivation of herbal materials. Reinvigorate, import, transplant and develop 10 - 15 species of medicinal plants imported in large quantities. 100% of medicinal ingredients (extracts, essential oils and medicinal powders) are standardized for domestic drug production.

dd) Achieve WHO's level 3 or higher certification of the capacity of regulatory bodies regarding chemical medicinal products, maintain and enhance WHO's certification of the capacity of regulatory bodies regarding vaccines.

e) Sustainably maintain the rate of 100% of drug business establishments meeting good practices; strive to have 100% of drug testing, vaccine testing, and biologicals testing facilities meeting Good Laboratory Practice (GLP); 20% of drug production establishments meeting EU-GMP, PIC-GMP or equivalent.

g) Strive to have 30% of domestically produced and imported generic drugs (except drugs with local effects, drugs with systemic effects that have bioequivalent properties with reference drugs) granted the marketing authorization and assessed as bioequivalent; 100% of drugs in circulation fully monitored and managed to guarantee their safety and effectiveness according to the regulations imposed by the Ministry of Health.

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i) Complete digital transformation of the pharmaceutical industry; digitalize 100% of information and data on drugs licensed for circulation that remain valid in Vietnam, update them to the Pharmaceutical Industry Data Bank; establish connectivity among all drug production, wholesaling, import-export and retailing establishments nationwide; maintain operation of 100% of level 4 online public services within the pharmaceutical sector integrated into the National Public Service Portal; apply artificial intelligence to pharmaceutical industry activities.

k) Achieve a pharmacist-to-population ratio of 4.0 pharmacists per 10,000 population, including at least 20% of these pharmacists who will receive training in clinical pharmacy.

3. Vision towards 2045:

Domestically produced drugs are expected to not only meet domestic demand but also significantly increase their export value, thereby stimulating deep integration into the global pharmaceutical supply chain; proactively produce specialized drugs for treatment, new drugs, original brand-name drugs, vaccines, biologicals and medicinal materials; have original brand-name drugs derived from sources of domestic herbal materials which will be researched, produced and copyrighted. The pharmaceuticals industry is projected to contribute over 20 billion USD to the country's GDP. The drug testing and distribution system, clinical pharmacy, drug information and pharmacovigilance will achieve the same level as developed countries in the world.

III. MAJOR TASKS AND SOLUTIONS

1. Continuing to perfect regulations and laws

a) Improve pharmaceutical laws related to production, trading, import, export, supply, distribution and use of drugs and medicinal materials, ensuring that they are properly and appropriately managed in harmony with international regulations. Those laws shall also specify investment incentives including the most favorable incentives for research, technology transfer and production of innovator drugs, specialized drugs for treatment, generic drugs having hi-tech dosage forms, vaccines, reference biologicals, biosimilars and drugs derived from Vietnam’s herbal materials bearing national brand names, production of medicinal materials, etc.

b) Complete regulations on management of drug distribution and supply systems; attach importance to regulations on bidding and procurement, ensure openness and transparency, give priority to high quality drugs at affordable prices, avoid drug shortages.

c) Perfect regulations on protection and enforcement of intellectual property rights for drugs in Vietnam, facilitate the grant of marketing authorization for generic drugs whose patents are about to expire and first biosimilars, orphan drugs and vaccines which have been pre-qualified by the World Health Organization.

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dd) Offer incentives for investment in establishment and development of internationally accredited clinical testing centers in development of new drugs and in vivo bioequivalence study in Vietnam. Increase the number of active ingredients for which bioequivalence study reports are required according to the roadmap.

e) Formulate appropriate import policies in accordance with treaties to which Vietnam is a signatory. Vigorously promote the pharmaceutical chemistry industry, introduce appropriate policies to support the production of chemical medicinal materials, and restrict the import of chemical medicinal materials that Vietnam has produced.

g) Develop long-term, transparent and preferential policies and create a favorable environment to strive to become a high value pharmaceuticals production center in the region.

2. Planning

a) Pay attention to allocating and reserving land for the development of drug research centers and production facilities in accordance with the planning approved by competent authority.

b) Complete and organize the effective implementation of the State's planning for drug and medicinal material testing system according to regulations; focus on maintaining capacity of the testing system to promptly meet management needs, effectively support production and business activities and be able to achieve international integration. Boost private sector involvement and public - private cooperation to invest in and develop the testing system.

c) Re-organize drug bioavailability research and bioequivalence assessment (BA/BE) centers; invest in upgrading existing centers and building new BA/BE centers, clinical and pre-clinical testing centers.

d) Review and formulating planning for the drug supply system in a professional, modern and effective manner; focus on developing a system for supply of drugs to ethnic minorities, people in mountainous areas, islands, and extremely disadvantaged areas.

dd) Include in the planning the herbal materials that are suitable for natural conditions of each region, create chain links from farming to processing and production of drugs, medicinal materials, cosmetics, and functional foods to serve domestic and export needs.

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a) Promote the mobilization of all resources from domestic and foreign organizations and individuals to promote investment in research, testing, and development of domestic production of drugs, vaccines and biologicals, and production of medicinal materials; invest in building bioavailability research and bioequivalence assessment (BA/BE) centers; invest in establishing international clinical trial centers (multi-center).

b) Prioritize investment in the construction of pharmaceutical industrial parks to attract investors to develop projects to produce original brand-name drugs that remain copyrighted, and to produce drugs under processing contracts immediately after the expiration of the patent or relevant exclusive certificates; specialized drugs for treatment, generic drugs having hi-tech dosage forms; vaccines and biologicals using transferred technology, multivalent vaccines, drugs and vaccines intended for prevention of emerging, dangerous and highly infectious diseases in the community and vaccines under expanded programs on immunization. Consider building specialized laboratories for drug research and development. The State shall take the lead in doing so and offer appropriate incentives to enterprises and research centers so as for them to make investment.

c) Design a roadmap for improving the international competitiveness of the pharmaceutical industry. Periodically organize trade promotion activities to attract investment and transfer production technology from hi-tech drug production facilities, foreign-invested companies, multinational pharmaceutical corporations, companies from countries with developed pharmaceuticals industry.

d) Properly manage the domestic drug supply and distribution system in a modern, professional and effective way. Encourage the application of EU-GSP, EU-GDP and EU-GPP (Good Storage Practices, Good Distribution Practices and Good Pharmacy Practices according to European standards), build drug warehouses and system of vehicles meeting high technical standards, promote the connectivity among and increase the efficiency in connecting drug suppliers.

d) Build herbal material value chains, cooperation and attachment mechanisms among farmers, scientists, governments and enterprises in seed transfer, cultivation techniques, harvesting, purchasing, production and processing of domestic herbal materials. Develop policy mechanisms and policies to encourage large Vietnamese enterprises to play a leading role in the pharmaceuticals industry through incentives for developing areas for cultivation, collection and processing of herbal materials, transfer of modern and high technology, and order placement and task assignment by the Government. Accelerate the implementation of the policy to assist small and medium-sized enterprises in participating in value chain links in the pharmaceutical industry.

4. Improving capacity for managing and controlling the drug and medicinal material market

a) Research and complete the innovation of the model of pharmaceutical industry organization system at the national level, ensuring its modernity, efficiency and conformity international practices. Improve the capacity of central and local pharmacy authorities and proactively and proactively achieve international integration in such a way to be on a par with developed countries.

b) Manage quality of drugs and medicinal materials in a proper and comprehensive way that covers the production, export, import, storage, circulation, distribution and use of drugs; resolutely prevent, combat and handle counterfeit and poor-quality drugs.

c) Intensify the operation of the system for post-marketing inspection and audit of business activities of pharmaceutical enterprises to maintain order and discipline, and strengthen the compliance with pharmaceutical legislation.

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dd) Strengthen the prevention of and combat against smuggling and illegal cross-border transport of herbal materials; thoroughly inspect imported and exported herbal materials and documents relating to the import and export if any suspicion exists in order to detect violations and prevent herbal materials with rare and endemic genetic resources in the country from being transported abroad. Develop an herbal material monitoring and tracing system. Preserve endemic and rare genetic resources having high economic value; sustainably collect and restrict the export of rare and endangered herbal materials.

5. Using drugs in a reasonable, safe and effective manner

a) Effectively conduct clinical pharmacy activities according to the roadmap under in relevant legal documents.

b) Improve the quality of pharmacovigilance activities at health facilities and pharmacies; focus on improving the role and capacity of pharmacists in giving advice on the reasonable, safe and effective use of drugs from the central health authority to the grassroots health authority.

c) Complete and implement good prescribing practices and good pharmacy practices; properly manage drug information dissemination and advertising activities.

d) Carry out effective and safe monitoring activities and manage risks related to drugs in the course of circulating products at drug business establishments in Vietnam.

dd) Improve patients and community's awareness and knowledge of safe and rational use of drugs.

6. Science, technology, human resources and training

a) Promote research into and participate in international cooperation in development of original brand-name drugs, specialized drugs for treatment, generic drugs having hi-tech dosage forms, vaccines, reference biologicals, biosimilars and drugs derived from herbal materials and application of modern drug preparation technology; conduct clinical trials and assess bioequivalence.

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c) Have a specific orientation and roadmap to standardize basic training, continuing training and advanced training for pharmaceutical personnel. Improve the quality of training for pharmaceutical personnel, give priority to training in clinical pharmacy, quality management, research into, development and processing of drugs, and transfer of technology in response to social development and international integration. Intensify the inclusion of specialized training in vaccines, biologicals, bioequivalence research, clinical testing, processing and technology transfer in the pharmacist training program.

d) Focus on investing in research into and application of advanced and modern technology to the preservation of endemic, precious and high economic value genetic resources of herbal materials, research into, selection and creation of new varieties from genetic resources of domestic and imported herbal materials, and cultivation techniques for high yield and quality; to preliminary processing, extraction, preparation and standardization of herbal materials and drugs from herbal materials. Collect, study and inherit recipes and experience in using medicinal plants of ethnic groups in the community.

7. International cooperation

a) Promote cooperation with multinational pharmaceutical corporations to accelerate research into and transfer of technology for producing original brand-name drugs in Vietnam and generic drugs having hi-tech dosage forms.

b) Actively and proactively carry out bilateral and multilateral cooperation activities, take advantage of resources and professional and technical support from countries and international organizations, including programs and projects to improve the capacity and efficiency of pharmacy authorities. Allocate resources for effective implementation of Vietnam's international agreements and commitments regarding pharmacy.

c) Speed up cooperation and connection and sharing of pharmaceutical administration database with stringent regulatory authorities. Promote harmonization of documents and procedures related to pharmaceutical administration as close to international standards as possible; consider implementing recognition and accreditation mechanisms in pharmaceutical administration in accordance with international practices.

8. Information technology, application of the Industry 4.0 technology in association with the implementation of artificial intelligence and digital transformation with a view to modernization of the pharmaceutical industry

a) Develop and complete the national pharmacy database, apply big data technologies (Big Data) to building and storage of pharmaceutical data. Apply Analytics to analyze data, establish a synchronous system for monitoring of drug supply and optimization of drug usage on patients nationwide in a timely and accurate manner.

b) Complete the online connection of drug business data on the production, import, export, wholesaling, retailing and use of drugs, focus on monitoring drug quality, prices, information and origin. Apply and manage codes and barcodes of drugs and herbal materials circulated on the market for the purposes of tracing and quality management.

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d) Render level 4 online public services, apply artificial intelligence to handling of administrative procedures in the pharmaceutical field.

dd) Introduce incentives according to a roadmap so as for pharmaceutical enterprises to standardize management processes and implement digital transformation.

9. Information and communications

a) Strengthen communications to raise pharmacy business establishments’ awareness of the Communist Party's guidelines and policies and the State's laws on pharmacy, scientific and technological activities and integration trends within the pharmaceutical sector.

b) Mobilize resources to enhance communication and raise practitioners’ awareness of medical examination, treatment and pharmacy and patients' awareness of safe and effective use of drugs and use of drugs of clear origin and good quality.

c) Communicate information on the quality, safety, effectiveness and reasonable prices of domestically produced drugs, information on the origin and effects of herbal material, especially herbal materials endemic to Vietnam.

d) Intensify the dissemination of information on and advertising of medicinal products and herbal materials bearing national brand names.

IV. SOURCES OF CAPITAL

Diversify sources of capital raised and effectively use resources to implement the Strategy:

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2. Funding provided from the budget of national target programs, public investment programs and projects in 2022 - 2030 period.

3. Capital raised from foreign donors, WHO, international organizations, domestic and foreign enterprises and individuals, ODA and other legal sources of funding.

4. Other financial sources prescribed by law.

Article 2. Implementation

1. The Ministry of Health shall:

a) Conduct a study and suggest the Prime Minister to establish the National Steering Committee for Development of Vietnam's Pharmaceutical Industry by 2030, with a vision towards 2045.

b) Formulate, perfect and submit to a competent authority for promulgation and approval or promulgate and approve within its power legislative documents, mechanisms, policies and plans to implement tasks and solutions under the Strategy.

c) Preside over and cooperate with relevant ministries and central authorities to develop training plans and employing high quality pharmaceutical personnel to meet the needs for drug research and production. Strengthen capacity and ensure effectiveness of pharmacy authorities nationwide.

d) Preside over and cooperate with the Ministry of Agriculture and Rural Development to direct the development of medicinal herbal material cultivation areas, focus on high economic value herbal materials in which Vietnam has an advantage.

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e) Regularly announce pharmaceutical mechanisms and policies to relevant units and international partners and update them on such pharmaceutical mechanisms and policies.

g) Continue to organize and effectively conduct the campaign “Người Việt Nam ưu tiên dùng thuốc Việt Nam” (“Vietnamese nationals prioritize Vietnamese medicine”).

h) Provide guidance on, inspect and expedite the implementation of the Strategy, periodically conduct preliminary and final reviews, and report the implementation of the Strategy to the Prime Minister.

2. The Ministry of Finance shall:

a) Preside over and cooperate with the Ministry of Health and relevant ministries and central authorities to conducting review and study, and requesting a competent authority to amend regulations on tax policies, fees and charges within the pharmaceutical sector to make them practically suitable.

b) Balance and allocate regular funding covered by the central budget to realize contents of the Strategy within the jurisdiction of the central government applicable regulations on hierarchical management of state budget and within the capacity for balancing the annual budget.

3. The Ministry of Industry and Trade shall:

a) Preside over and cooperate with relevant ministries and agencies in developing and organize the implementation of contents related to the development of the pharmaceutical chemical industry, including the production of chemical medicinal materials and products in support of drug manufacturing.

b) Cooperate with the Ministry of Health in formulating pharmaceuticals import policies and mechanisms, including reasonable technical barriers and strengthening trade promotion activities to support the export of domestically produced drugs.

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a) Preside and cooperate with the Ministry of Health and relevant ministries and central authorities in studying, reviewing and perfecting regulations on investment incentives within the pharmaceutical sector, procurement and bidding to facilitate the development of domestic pharmaceuticals industry.

b) Balance and allocate investment capital from the central budget to realize contents of the Strategy within the jurisdiction of the central government applicable regulations on hierarchical management of state budget, Law on Public Investment and relevant regulations of law.

5. The Ministry of Science and Technology shall:

a) Preside over and cooperate with ministries, ministerial agencies and Governmental agencies to organize the implementation of national scientific tasks within the pharmaceutical sector.

b) Preside and cooperate with the Ministry of Health to review and propose the support, grants and incentives from the National Foundation for Science and Technology Development, National Technology Innovation Foundation and National Hi-Tech Venture Capital Fund in service of research and development activities within the pharmaceutical sector.

6. Ministries and central authorities shall, within their jurisdiction, realize or cooperate with the Ministry of Health in realizing contents of this Strategy.

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

a) Integrate and organize the implementation of objectives, tasks and solutions; execute programs and plans specified in the Strategy within their provinces in a manner that suits their local advantages and practical conditions. Allocate capital from their local budget to realize contents of the Strategy within their jurisdiction under regulations on hierarchical management of state budget.

b) Organize promotion, attract investment, provide financial support, prioritize the allocation of land for construction of factories, pharmaceutical industrial parks, pharmaceuticals research and testing centers, and development of herbal materials within their provinces.

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Article 4. Ministers, heads of ministerial agencies, heads of Governmental agencies, Chairpersons of People’s Committees of provinces and central-affiliated cities, heads of related agencies are responsible for the implementation of this Decision./.

PP. THE PRIME MINISTER
THE DEPUTY PRIME MINISTER




Tran Hong Ha

APPENDIX

LIST OF PRIORITIZED PROGRAMS AND PROJECTS
(Promulgated together with the Prime Minister's Decision No. 1165/QD-TTg dated October 09, 2023)

No.

Name of program, project

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Cooperating unit

Deadline for submission

1

Law on Pharmacy Bill (amendment)

Ministry of Health

Relevant ministries and central authorities

According to the schedule in the Program for formulation of Laws and Ordinances

2

Pharmaceutical chemistry industry development program

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Relevant ministries and central authorities

2024

3

Comprehensive program for development and realization of potential of herbal materials

Ministry of Health

Ministry of Agriculture and Rural Development and ministries and central authorities

2024