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MINISTRY OF
HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 2614/QD-BYT
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Hanoi, July
16, 2014
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DECISION
PROMULGATION OF “PLAN FOR DEPLOYMENT OF NATIONAL STRATEGY
FOR DEVELOPMENT OF THE VIETNAM’S PHARMACY INDUSTRY BY 2020 AND ORIENTATION
TOWARDS 2030 UNDER THE PRIME MINISTER’S DECISION NO. 68/QD-TTG DATED JANUARY
10, 2014”
THE
MINISTER OF HEALTH
Pursuant to the Government's Decree No.
63/2012/ND-CP dated August 31, 2012 defining the functions, tasks, powers and
organizational structure of the Ministry of Health;
Pursuant to the Prime Minister’s Decision No.
68/QD-TTG dated January 10, 2014 on approval for National Strategy for
Development of the Vietnam’s pharmacy industry by 2020 and orientation towards
2030
At the request of the Director of Drug
Administration of Vietnam - the Ministry of Health,
DECIDES:
Article 1. The “Plan for deployment of National Strategy for
Development of the Vietnam’s pharmacy industry" by 2020 and orientation
towards 2030 under the Prime Minister’s Decision No. 68/QD-TTG dated January
10, 2014” is promulgated together with this Decision.
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Article 3. Chief of the Ministry Office, the Director of Drug
Administration of Vietnam, heads of units affiliated to the Ministry of Health
are responsible for the implementation of this Decision./.
MINISTER
Nguyen Thi Kim Tien
PLAN
DEPLOYMENT OF NATIONAL STRATEGY FOR DEVELOPMENT OF THE
VIETNAM’S PHARMACY INDUSTRY BY 2020 AND ORIENTATION TOWARDS 2030 UNDER THE
PRIME MINISTER’S DECISION NO. 68/QD-TTG DATED JANUARY 10, 2014
No.
Contents
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Cooperating
agency
Expected
products
Deadline
(1)
(2)
(3)
(4)
(5)
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1
Formulating,
introducing policies and laws on pharmacy
1.1
Amendments the Law on Pharmacy to encourage
manufacture and use of domestic drugs, standardize requirements for selling
drugs, apply Good Practices (GPs), provide drugs, invite bids, tightly
control drug prices, and perform other tasks that suit socio-economic
conditions of Vietnam and the course of international integration.
Drug Administration of Vietnam
Legal Department, Drafting Board
Draft amendments to the Law on Pharmacy passed
by the National Assembly
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1.2
Formulation of legislative documents that
provide guidelines for the Law on Pharmacy.
Drug Administration of Vietnam
Legal Department, Drafting Board
Legislative documents promulgated by competent
authorities
According to annual plans
1.3
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1.3.1
Assessment of the manufacture, export, import,
supply, consumption, and affordability of essential medicines
Health Strategy and Policy Institute
Drug Administration of Vietnam, Traditional
Medicine Administration of Vietnam, Health insurance Office, Vietnam
Pharmaceutical Companies Association, Vinapharm
Reports approved by the Ministry of Health
2014-6/2015
1.3.2
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Hanoi University of Pharmacy (National Institute
of Pharmaceutical Technology), Administration of Science Technology and
Training
Drug administration of Vietnam, National
Institute of Medicinal Materials, Vinapharm, Vietnam Chemicals Agency (the
Ministry of Industry and Trade), National Program for Pharmacy Development
Researches approved and conducted.
Annually
1.3.3
Review, revise the list of essential medicines
Drug administration of Vietnam, Traditional
Medicine Administration of Vietnam
Medical Examination & Treatment
Administration
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Every 3 - 5
years
1.3.4
Project: improve access to essential medicines
and competence of pharmaceutical officials of communes in rural areas,
highlands, and islands
Health Strategy and Policy Institute
Drug administration of Vietnam, Traditional
Medicine Administration of Vietnam, Organization and Personnel Office,
Administration of Science Technology and Training, Planning - Finance Office
A new project approved.
6/2015- 2016
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Announce a list of essential medicines given
priority when they are researched, registered, or manufactured in Vietnam
Drug Administration of Vietnam
Traditional Medicine Administration of
Vietnam, Administration of Science Technology and Training, Health Strategy
and Policy Institute, Vietnam Pharmaceutical Companies Association, Vinapharm
Decision(s) of the Minister of Health
Periodically
(after the tasks in 1.3.3 are done)
1.3.6
Complete policies on encouraging research, manufacture,
export, supply, and use of essential medicines made in Vietnam, import of
essential medicines that cannot be manufactured in Vietnam; ensure that the
people can access, select, and use safe, effective, and affordable drugs.
Drug Administration of Vietnam
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Legislative documents approved by competent
authorities
2017
1.4
Generic medicines
1.4.1
Conduct researches into manufacture and
improvement of quality of generic drugs, ingredients thereof, and excipients.
Hanoi University of Pharmacy (National Institute
of Pharmaceutical Technology), Administration of Science Technology and
Training
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Researches approved and conducted.
Annually
1.4.2
List of generic drugs and
schedule for compulsory BA/BE studies.
Drug Administration of Vietnam
National Institute of Drug Quality Control,
Institute of Drug Quality Control of Ho Chi Minh City
Circular(s) promulgated by the Ministry of
Health
2015
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1.4.3
List of active ingredients
whose patent protections have expired or are going to expire.
Drug Administration of Vietnam
National Office of Intellectual Property - the
Ministry of Science and Technology
An Official Dispatch from Drug Administration
of Vietnam
Annually
1.4.4
Regulations on prescription,
use, and sale of drugs having generic names and international nonproprietary
names.
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Hospitals, drugstores
Guiding Circular(s) promulgated by the
Ministry of Health
2015
1.4.5
Regulations on giving priority
to the first company who registers domestic manufacture of generic drugs
(priority given to registration, market penetration, drug prices)
Drug Administration of Vietnam
Relevant units
Guiding Circular(s) promulgated by the
Ministry of Health
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1.4.6
Regulations on restriction on
import of medicinal materials and generic drugs that can be manufactured in
Vietnam.
Drug Administration of Vietnam
Relevant units
Circular(s)/Decision(s) of the Minister of
Health
Annually
1.5
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1.5.1
List of specialized drugs, drugs having
special dosage forms, vaccines, biologicals given priority when they are
researched, registered, or manufactured in Vietnam.
Drug Administration of Vietnam
General Department of Preventive Medicine,
Medical Equipment & Construction Office, Administration of Science
Technology and Training.
Decision(s) of the Minister of Health
Every 2 years,
starting from 2014
1.5.2
Conduct researches into application of
advanced medicine preparation technologies
Administration of Science Technology and
Training
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Researches approved and carried out.
Annually
1.5.3
Policies on incentives for research,
manufacture, import, export, supply and use of specialized drugs, drugs
having special dosage forms, vaccines, biologicals
Drug Administration of Vietnam
The Ministry of Planning and Investment, the
Ministry of Finance, the Ministry of Industry and Trade
Legislative documents approved by competent
authorities
2017
1.5.4
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Administration of Science Technology and
Training
General Department of Preventive Medicine, National Institute for Control of
vaccine and biologicals, Open Vaccination Program
Researches approved and applied.
Annually
1.5.5
National programs for development of
Vietnamese vaccines
Administration of Science Technology and
Training
Vietnamese Product Program Steering Committee
Programs approved and launched
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1.5.6
Project: Arrangement of vaccine manufacturers
towards specialization
Drug Administration of Vietnam
Business Development and Innovation board -
the Ministry of Health
Project approved by the Ministry of Health
2015
1.5.7
Project: Development of Clinical Testing
Center
Administration of Science Technology and
Training
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Projects approved and carried out.
2015-2017
1.6
Vietnamese herbal medicines
1.6.1
Development of Vietnamese herbal medicines
Administration of Science Technology and
Training, Vietnamese Product Program Steering Committee
Drug Administration of Vietnam, Traditional
Medicine Administration of Vietnam, National Institute of Medicinal Materials,
the Ministry of Science and Technology
List of Vietnamese herbal medicines approved
by the Prime Minister
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1.6.2
Quality standards applied to herbal medicines.
Vietnam Pharmacopoeia Council, Drug
Administration of Vietnam.
National Institute of Drug Quality Control,
Institute of Drug Quality Control of Ho Chi Minh City,
New treatises
Annually
1.6.3
R&D projects on safety and effectiveness
of herbal medicines
Administration of Science Technology and
Training
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Researches approved and applied.
Annually
1.6.4
Regulations on documents about assessment of
toxicity, safety, and effectiveness of herbal medicines in an application for
drug registration.
Drug Administration of Vietnam
Traditional Medicine Administration of
Vietnam, Administration of Science Technology and Training
New circular(s)
12/2015
1.6.5
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Traditional Medicine Administration of Vietnam
Drug administration of Vietnam, Administration
of Science Technology and Training.
New Circular(s)
12/2015
1.6.6
Regulations on priority given to herbal
medicines covered by government budget and health insurance.
The Ministry of Health (Drug Administration of
Vietnam, Planning - Finance Office, Health insurance Office)
The Ministry of Finance, Vietnam Social
Insurance Authority
New Joint Circular(s)
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1.6.7
Trade promotion for herbal medicines among
Vietnamese products
Drug Administration of Vietnam
Traditional Medicine Administration of
Vietnam, Vietnam Pharmaceutical Companies Association, pharmaceutical
companies, the Ministry of Industry and Trade
Propagation projects, prizes, and trade
promotions
Annually
1.6.8
Preferential policies on encouragement of
Vietnamese herbal medicines
Drug Administration of Vietnam
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Legislative documents approved by competent
authorities
2017
1.7
Safe, reasonable, and effective use of
drugs
1.7.1
Compilation of documents about good
prescription practice
Medical Examination & Treatment
Administration
Hospitals, Services of Health, Drug
Administration of Vietnam
Specialized documents issued by the Minister
of Health
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1.7.2
Amendments to regulations on Good Pharmacy
Practice, enhancement of implementation thereof
Drug Administration of Vietnam
Services of Health
Amendments to Circular(s) by the Minister of
Health
12/2015
1.7.3
Amendments to circulars or promulgation of new
circulars on pharmacovigilance, drug information, drug advertising,
Drug Administration of Vietnam
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Circular(s) and instructions issued by the
Ministry of Health
2014-2015
1.8
Clinical pharmacology
1.8.1
Development of clinical pharmacology syllabus
Hanoi University of Pharmacy
Administration of Science Technology and
Training, Drug administration of Vietnam, Traditional Medicine Administration
of Vietnam, medical universities
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2015
1.8.2
Target for training clinical pharmacists
Administration of Science Technology and
Training
The Ministry of Education and Training
New targets
Annually
1.8.3
Amendments to regulations on clinical
pharmacology applied to medical facilities
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Medical Examination & Treatment
Administration, Organization and Personnel Department, Traditional Medicine
Administration of Vietnam
Circular(s) promulgated by the Ministry of
Health
2016
2
Formulation, launch
of projects for development of pharmacy industry
2.1
Development of pharmacy industry
2.1.1
Instructions on principles and standards for
GMP according to PIC/s and implementation plan.
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Pharmaceutical companies
Circular(s) promulgated by the Ministry of
Health
2015
2.1.2
Plan for development of pharmacy industry of
Vietnam by 2020 and the orientation towards 2030
Drug Administration of Vietnam
Relevant units
Decision(s) promulgated by the Ministry of
Health
2015
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Development of drug distribution system
2.2.1
Instructions on planning for development of
existing drug distribution systems
Drug Administration of Vietnam
Pharmaceutical companies
Documents (s) promulgated by senior officers
of the Ministry of Health
12/2014
2.2.2
5 drug distribution centers in the northern
highlands, the north central coast, the south central coast, the central highlands,
the southeast, and the Mekong delta
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Pharmaceutical companies
Executed projects of investment (with
incentives)
2015-2020
2.2.3
Support in supply of drugs for beneficiaries
of social policies, ethnic minorities, the poor, and people in remote areas.
The Ministry of Health (Drug Administration of
Vietnam, Planning - Finance Office)
The Ministry of Finance, the Ministry of
Labor, War Invalids and Social Affairs.
New Joint Circular(s)
2016
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Plan for development of drug distribution
system by 2020 and the orientation towards 2030
Drug Administration of Vietnam
Relevant units
Decision(s) promulgated by the Ministry of
Health
2015
2.3
Testing system for drugs and products that
have direct effect on human health
2.3.1
Project: establishment of 05 centers where
drugs and products and products that have direct effect on human health are
tested in the northern highlands, northern coastal provinces, the central
coast, the central highlands, and the southeast
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Organization and Personnel Department, Vietnam
Food Administration, National Institute for Control of vaccine and
biologicals, National Institute for Food Safety Control.
Decisions on establishment issued by the
Ministry of Health
12/2014
2.3.2
Mechanism for cooperation among units
affiliated to the Ministry of Health that test drugs, vaccines, biologicals,
cosmetics, and products that have direct effect on human health
Drug Administration of Vietnam, Organization
and Personnel Department.
Vietnam Food Administration, the National
Institute of Drug Quality Control, Institute of Drug Quality Control of HCMC
National Institute for Control of vaccine and biologicals, National Institute
for Food Safety Control.
Decisions issued by the Ministry of Health
12/2014
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Rearrangement of units affiliated to Services
of Health that test drugs, vaccines, biologicals, cosmetics, and products
that have direct effect on human health
Drug administration of Vietnam, National
Institute of Drug Quality Control, Institute of Drug Quality Control of Ho
Chi Minh City.
Organization and Personnel Department, Vietnam
Food Administration, National Institute for Control of vaccine and
biologicals, National Institute for Food Safety Control.
Projects approved by competent authorities
2015
2.4
Planning for bioavailability/bioequivalence
research centers to satisfy market demands
Drug Administration of Vietnam
National Institute of Drug Quality Control,
Institute of Drug Quality Control of Ho Chi Minh City,
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9/2014
2.5
Implementation of the Master plan for pharmacy
development by 2020 and orientation towards 2030
Traditional Medicine Administration of Vietnam
Relevant units
Plan for implementation of the Master plan
approved by the Ministry of Health
8/2014
2.6
Make a plan for training, attracting,
employing pharmacy staff, ensuring reasonable distribution of pharmacists
among disadvantaged areas, rural areas, highlands, remote areas, bordering areas,
and islands; employ sufficient pharmacy staff in pharmacy authorities
nationwide; provide training for clinical pharmacists and pharmacy officials.
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Organization and Personnel Department, Drug
administration of Vietnam, Medical Examination & Treatment
Administration, Traditional Medicine Administration of Vietnam, medical
universities, and relevant units
A plan approved by the Minister of Health
6/2015
3
Inspection and
fortification
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Employ more staff, fortify the inspection
network nationwide.
Inspectorate of the Ministry of Health
Drug Administration of Vietnam, Organization
and Personnel Department, Services of Health
A project approved by the Minister of Health
6/2015
3.2
Cooperate with relevant units in inspecting,
supervising drugs on the market and adherence to pharmacy laws
Drug Administration of Vietnam
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A plan approved by the Minister of Health
Annually
3.3
Project: Uniform management of
pharmaceuticals, cosmetics, foods, and products that have direct effect on
human health among regulatory bodies affiliated to the Ministry of Health.
Drug Administration of Vietnam
Organization and Personnel Department, Vietnam
Food Administration, Medical Equipment and Construction Office Traditional
Medicine Administration of Vietnam
A the Prime Minister’s Decision to approve the
Project
2017
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3.4
Complete the role of national regulatory
authorities (NRA) in regulation of vaccines
Drug Administration of Vietnam
General Department of Preventive Medicine,
Administration of Science Technology and Training, National Institute for
Control of vaccine and biologicals.
Recognition by WHO
12/2014
3.5
Establishment of a force to inspect quality of
drugs, cosmetics, and products that have direct effect on human health.
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Vietnam Food Administration, the National
Institute of Drug Quality Control, Institute of Drug Quality Control of HCMC
National Institute for Control of vaccine and biologicals, National Institute
for Food Safety Control.
New Circular(s) promulgated by the Ministry of
Health
2015
3.6
Establishment of an GMP inspectorate
accredited by ASEAN
Drug Administration of Vietnam.
the National Institute of Drug Quality
Control, Institute of Drug Quality Control of HCMC
A GMP Inspectorate accredited by ASEAN.
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3.7
Perform tasks pertaining to the participation
in PIC/S (Pharmaceutical Inspection Co-operation Scheme)
Drug Administration of Vietnam.
the National Institute of Drug Quality
Control, Institute of Drug Quality Control of HCMC
A member of PIC/S
2020
4
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4.1
Investment in upgrade and modernization of
BE/BA testing center at National Institute of Drug Quality Control
National Institute of Drug Quality Control
Planning - Finance Office, Medical Equipment -
Construction Office
A project approved by the Minister of Health
2014-2015
4.2
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Institute of Drug Quality Control of HCMC.
Planning - Finance Office, Medical Equipment -
Construction Office
A project approved by the Minister of Health
2014-2015
4.3
Projects: Upgrades to National Institute for
Control of vaccine and biologicals to meet international standards
National Institute for Control of vaccine and
biologicals
Planning - Finance Office, Medical Equipment -
Construction Office
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2014-2016
4.4
Project: Investment in improving the competence
of Clinical pharmacology center affiliated to Hanoi Medical University.
Hanoi Medical University
Planning - Finance Office, Medical Equipment -
Construction Office, Drug Administration of Vietnam, Department of Personnel
Organization
A project approved by the Minister of Health
2014-2016
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Projects: upgrades to National Institute of
Pharmaceutical Technology, which is affiliated to Hanoi University of
Pharmacy
Hanoi University of Pharmacy
Planning - Finance Office, Medical Equipment -
Construction Office, Drug Administration of Vietnam.
A project approved by the Minister of Health
2014-2016
4.6
Investment in upgrade and modernization of 05
centers that test drugs, cosmetics, and foods in 5 regions: the northern
highlands, the red river delta, the central coast, the central highlands, and
the southeast.
Regional centers (inaugurated after 2.3.1).
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A project approved by the Minister of Health
2014-2020
4.7
Project: Upgrades to National Database for
Drug Information and Adverse Drug Reaction affiliated to Hanoi University of
Pharmacy
Hanoi University of Pharmacy
Planning - Finance Office, Medical Equipment -
Construction Office, Drug Administration of Vietnam.
A project approved by the Minister of Health
2015-2020
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4.8
Project: Upgrades to HCMC Database for Drug
Information and Adverse Drug Reaction affiliated to Cho Ray hospital
Cho Ray hospital
Planning - Finance Office, Medical Equipment -
Construction Office, Drug Administration of Vietnam.
A project approved by the Minister of Health
2015-2020
4.9
Project: National Database for Drug
Information and Adverse Drug Reaction.
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Drug administration of Vietnam, Organization
and Personnel Department
A project approved by the Minister of Health
2015-2016
4.10
Project: Establishment of 02 National
Laboratories for Biotechnology and Biosimilars
New laboratories (after establishment)
Planning - Finance Office, Medical Equipment -
Construction Office, Drug Administration of Vietnam, Department of Personnel
Organization
A project approved by the Minister of Health
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5
Preferred projects
5.1
Formulate and launch technology transfer
projects: study the manufacture of essential medicines, generic medicines,
and special active ingredients on purchased lines
Businesses
Drug Administration of Vietnam and relevant
agencies
Launched projects.
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5.2
Plan and carry out upgrades to vaccine and
biological production lines.
Vaccine manufacturers
Drug Administration of Vietnam and relevant
agencies
Launched projects.
2014-2016
5.3
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Businesses
Drug Administration of Vietnam and relevant
agencies
Launched projects.
2014-2016
5.4
Project: application of drug package
manufacture technologies
Businesses
Drug Administration of Vietnam and relevant
agencies
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2014-2016
5.5
Study and apply new technologies to manufacture
of medicines, vaccines, and biologicals that cannot be manufactured in
Vietnam
Businesses
Drug Administration of Vietnam and relevant
agencies
Launched projects.
2016-2020
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Formulate and launch ancillary industry
projects serving pharmaceuticals industry: paper, plastic, glass packages.
Businesses
Drug Administration of Vietnam and relevant
agencies
Launched projects.
2016-2020
5.7
Formulate and launch projects for manufacture
of high-tech medicinal products: multivalent vaccines, products of genetic
engineering, recombinants, stem cells
Businesses
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Launched projects.
2020-2030
6
Tasks performed in
cooperation with other Ministries, regulatory bodies, and local governments
6.1
Make plans and preparations in order for the
Steering Committee of the Ministry of Health to work with the Ministry of
Finance, the Ministry of Industry and Trade, the Ministry of Planning and
Investment, the Ministry of Agriculture and Rural Development
Drug Administration of Vietnam.
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Minutes of the meeting specifying guidelines
from senior officers of the Ministries.
Annually
6.2
Make plans and preparations in order for the
Steering Committee of the Ministry of Health to work with the People’s
Committees of provinces
Drug Administration of Vietnam.
The Steering Committee
Minutes of the meeting specifying guidelines
from senior officers of the Ministry of Health and the People’s Committees.
Annually
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7
The Steering
Committee
7.1
Establish a Steering Committee to implement
the Strategy
Drug Administration of Vietnam.
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A Decision of the Minister of Health
8/2014
7.2
Instruct local governments to plan the
implementation of the Strategy
The Steering Committee
Drug Administration of Vietnam and relevant
agencies
Dispatches that contain guidelines from the
Ministry of Health
8/2014
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7.3
Inspect and supervise the implementation of
the Strategy in the provinces by the units in charge
The Steering Committee
Drug Administration of Vietnam and relevant
agencies
Reports on inspections and supervisions.
Annually
7.4
Summary report, assessment of progress and
result of the Strategy (after each year and each stage)
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Drug Administration of Vietnam and relevant
agencies
A summary conference every year or after each
stage.
Annually and
after each stage
8.
Implementation
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8.1
Heads of the unit in charge must ensure the
quality, the progress, and cooperate with the Planning - Finance Office to
estimate the cost of each operation. Any difficulty should be reported to
senior officers of the Ministry.
8.2
Planning - Finance Office shall instruct
inferior units to estimate their budget for their operations.
8.3
Drug Administration of Vietnam shall report
the progress of the Plan, accomplishments of the units, and send periodic
reports to senior officers of the Ministry of Health.
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