Quyết định 2614/QD-BYT

No.

Contents

Agency in charge

Cooperating agency

Expected products

Deadline

(1)

(2)

(3)

(4)

(5)

(6)

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

According to the Program for Formulation of Laws and Ordinances of the National Assembly

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

Essential medicines

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

Conduct researches into manufacture of materials and finished products to essential medicines that cannot be manufactured in Vietnam.

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

A Circular promulgating the list of essential medicines

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

1.3.5

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

The Ministry of Planning and Investment, the Ministry of Finance, the Ministry of Industry and Trade

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

Drug administration of Vietnam, Traditional Medicine Administration of Vietnam, National Institute of Medicinal Materials, Vinapharm, Vietnam Chemicals Agency (the Ministry of Industry and Trade), pharmaceutical companies

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

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.

Drug administration of Vietnam, Medical Examination & Treatment Administration

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

2015

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

specialized drugs, drugs having special dosage forms, vaccines, biologicals

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

Pharmaceutical companies, universities, research institutes

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

Researches into safety and effectiveness of vaccines, especially those used for open vaccination programs

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

Annually

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

Drug administration of Vietnam, General Department of Preventive Medicine.

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

12/2015

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

Pharmaceutical companies, National Institute of Medicinal Materials, medical universities, National Institute of Pharmaceutical Technology

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

Regulations on recognition of traditional remedies and herbal medicines exempt from clinical trial.

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)

2015

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

The Ministry of Planning and Investment, the Ministry of Finance, the Ministry of Industry and Trade

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

12/2015

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

Relevant units

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

Approved syllabus

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

Drug Administration of Vietnam

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.

Drug Administration of Vietnam

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

2.2

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

Drug Administration of Vietnam

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

2.2.4

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

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.

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

2.3.3

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,

Decision(s) promulgated by the Ministry of Health

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.

Administration of Science Technology and Training

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

3.1

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

Inspectorate of the Ministry of Health, Traditional Medicine Administration of Vietnam, National Institute of Drug Quality Control, Institute of Drug Quality Control of Ho Chi Minh City, the General Department of Customs (the Ministry of Finance), Market Surveillance Agency (the Ministry of Industry and Trade)

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

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.

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.

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.

2016

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

Concentrated projects

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

Investment in upgrade and modernization of BE/BA testing center at Institute of Drug Quality Control of HCMC.

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

A project approved by the Minister of Health

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

4.5

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).

Planning - Finance Office, Medical Equipment - Construction Office, Drug Administration of Vietnam, the National Institute of Drug Quality Control, Institute of Drug Quality Control of HCMC.

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

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.

Hanoi University of Pharmacy

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

2020-2030

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.

2014-2016

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

Formulate and launch 03 projects of investment in BA/BE assessment in the north central coast, the south central coast, and the southeast.

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

Launched projects.

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

5.6

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

Drug Administration of Vietnam and relevant agencies

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.

The Steering Committee

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

7

The Steering Committee

7.1

Establish a Steering Committee to implement the Strategy

Drug Administration of Vietnam.

Organization and Personnel Department

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

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)

The Steering Committee

Drug Administration of Vietnam and relevant agencies

A summary conference every year or after each stage.

Annually and after each stage

8.

Implementation

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.