Decision No. 154/2006/QĐ-TTg On approving the Project "State Management of Medicines, Food Safety, and Cosmetics for the Period 2006-2015"

Pursuant to …;

Regarding the approval of the Project "State Management of Pharmaceuticals, Food Safety, and Cosmetics for the Period 2006-2015"

PRIME MINISTER

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

Pursuant to the Law on Health Protection for the People dated June 30, 1989;

Pursuant to the Drug Law dated June 14, 2005;

Considering the proposal of the Minister of Health.

Pursuant to …;

Article 1. Approve the Project "State Management of Pharmaceuticals, Food Safety, and Cosmetics for the Period 2006-2015" with the main contents as follows:

1. Objective: To enhance the quality and effectiveness of state management of pharmaceuticals, food safety, and cosmetics to meet the requirements of protecting, caring for, and improving people's health and international integration.

2. The scope of regulation under this Project includes: medicines (modern drugs, vaccines, medical products, traditional medicine, herbal-based medicines), food safety, and cosmetics.

3. Key tasks:

a) Continue to develop and perfect the system of regulatory legal documents for state management of pharmaceuticals, food safety, and cosmetics uniformly from central to local levels.

b) Strengthen and improve the capacity of state management agencies for pharmaceuticals, food safety, and cosmetics from central to local levels:

- At the central level: strengthen organizational structure and improve operational capacity of the Vietnam Drug Administration, the Food Safety Administration, and establish mechanisms for coordination among relevant units under the Ministry of Health in performing state management functions over pharmaceuticals, food safety, and cosmetics.

- At provincial and centrally-administered city levels: reorganize and strengthen the Pharmaceutical, Food Safety, and Cosmetic Management Departments; build and perfect the functions and responsibilities of the Pharmaceutical, Food Safety, and Cosmetic Testing Centers.

- Complete organization and enhance the capacity of drug and food safety inspection.

c) Develop planning for the testing system of pharmaceuticals, food safety, and cosmetics from central to local levels:

- Continue to invest in upgrading the Central Institute for Pharmaceutical Testing, the Ho Chi Minh City Institute for Pharmaceutical Testing, and the National Institute for Vaccine and Medical Biological Product Testing to meet international standards.

- Upgrade the Food Safety Testing Center under the Nutrition Institute to become the National Food Safety Testing Institute; transform the Food Testing Department under the Ho Chi Minh City Public Health Institute into a Food Safety Testing Center meeting international standards.

- Establish three testing centers for pharmaceuticals, vaccines, medical biological products, food safety, and cosmetics in the Northern Mountainous Region, Central Region, and Mekong Delta to meet international standards; reorganize and adjust the Pharmaceutical, Food Safety, and Cosmetic Testing Centers in provinces and centrally-administered cities.

d) Build three bioequivalence testing and drug efficacy evaluation centers in Hanoi, Da Nang, and Ho Chi Minh City to meet international standards to serve as a basis for rational, quality, and safe drug selection.

đ) Consolidate, reorganize, and upgrade the organizational structure, infrastructure, and equipment for two drug information centers and adverse drug reaction monitoring centers in Hanoi and Ho Chi Minh City. Establish three regional centers in the Northern Mountainous Region, Da Nang, and Can Tho.

e) Develop human resources for managers in the pharmaceuticals, food, and cosmetic sectors; strengthen training and retraining in specialized knowledge and management skills for staff working in the pharmaceuticals, food safety, and cosmetic management sector.

g) Build state management agencies for pharmaceuticals, food safety, and cosmetics suitable for development needs, specific characteristics of Vietnam, and trends in regional and global integration.

4. Implementation measures:

a) Regarding mechanisms and policies:

- Develop and perfect the system of regulatory legal documents and mechanisms and policies serving state management of pharmaceuticals, food safety, and cosmetics, particularly policies encouraging investment and production development in the pharmaceuticals, food, and cosmetic sectors; support policies for people in remote, mountainous, and economically disadvantaged areas.

- Develop mechanisms and policies to encourage and attract specialized management staff with university-level qualifications to work at local levels, especially in remote and mountainous areas.

b) Regarding investment and finance:

- Increase investment in upgrading infrastructure and technical equipment for state management of pharmaceuticals, food safety, and cosmetics at both central and local levels. Build an information system to serve state management of pharmaceuticals, food safety, and cosmetics from central to provincial and district levels.

c) Regarding human resource training:

- Survey and assess the current status of human resources in the pharmaceuticals, food safety, and cosmetic sectors, particularly those in state management, to serve as a basis for developing training, upgrading, staffing, and utilizing personnel effectively.

- Train state management knowledge of pharmaceuticals, food safety, and cosmetics for managers at all levels from central to local.

- Plan training for university-level staff in pharmaceuticals, food, and cosmetics for mountainous provinces; strengthen training for pharmacy graduates and pharmacy technicians for district level; pharmacy technicians and assistants for commune level.

- Develop preferential training policies and encourage staff working in primary healthcare facilities in economically disadvantaged areas to participate in regular or short-term courses on state management in the pharmaceuticals, food safety, and cosmetic sectors.

d) Regarding ensuring quality and safety in the pharmaceuticals, food, and cosmetic sectors:

- Issue and apply Good Practice (GP) principles according to World Health Organization standards in all stages of production, quality control, storage, and distribution in all pharmaceuticals, food, and cosmetic manufacturing and trading establishments to ensure quality, efficacy, and safety when used.

- Issuing good manufacturing practice standards for traditional drugs and good agricultural and collection practices for medicinal materials to ensure the supply of standard medicinal materials for drug production.

- Standardizing medicinal materials and drugs derived from medicinal materials in accordance with international and regional common standards.

d) On international cooperation:

- Strengthening cooperation with countries in the Asia-Pacific region and worldwide, and international pharmaceutical federations to collect market information and share management experience.

- Expanding international cooperation in specialized training on management and technical economic work in the fields of pharmaceuticals, food safety, and cosmetics.

e) On propaganda and education:

- Enhancing communication and education efforts to raise public awareness about the rational and safe use of medicines, food, and cosmetics.

- Promoting the quality of domestically produced medicines, addressing the preference for imported and branded medicines.

- Enhancing propaganda efforts on hygiene and safety in the production, storage, circulation, and distribution of food.

- Strengthening coordination between state management agencies and mass media organizations in propaganda and educational activities related to pharmaceuticals, food safety, and cosmetics.

g) On inspection, supervision, and handling of violations:

- Strictly implementing periodic inspections and supervision of pharmaceuticals, food safety, and cosmetics. Reviewing, amending, and supplementing regulations on penalties for violations in these areas.

- Reforming and strengthening collaboration between inspectors and relevant functional agencies to enhance inspection and supervision work and handle violators within the scope of legal management.

5. Implementation roadmap

a) From 2006 to 2007:

- Evaluating the current status of the national management system for pharmaceuticals, food safety, and cosmetics.

- Reviewing, amending, and supplementing the legal framework for pharmaceuticals, food safety, and cosmetics.

- Improving and enhancing the capacity of state management for pharmaceuticals, food safety, and cosmetics from central to local levels.

- Investing in upgrading the Central Institute of Pharmaceutical Inspection, the Ho Chi Minh City Institute of Pharmaceutical Inspection, and the National Institute of Vaccine and Biological Product Quality Control to meet international standards; upgrading the Food Inspection Department of the Ho Chi Minh City Public Health Institute into an International Food Inspection Center.

- Consolidating, improving, and investing in organizational structure, infrastructure, and equipment for two drug information centers and adverse drug reaction monitoring centers in Hanoi and Ho Chi Minh City.

b) From 2008 to 2012:

- Continuing to review, amend, and supplement the legal framework for state management in the fields of pharmaceuticals, food safety, and cosmetics.

- Establishing three drug information centers and adverse drug reaction monitoring centers in the northern mountainous region, Da Nang, and Can Tho.

- Establishing three pharmaceutical inspection centers, vaccine and biological product inspection centers, food safety inspection centers, and cosmetic inspection centers in the northern mountainous region, central region, and Mekong Delta.

- Establishing three bioequivalence testing and drug bioavailability evaluation centers in Hanoi, Da Nang, and Ho Chi Minh City meeting international standards.

- Establishing the National Institute of Food Safety Inspection.

c) From 2013 to 2015:

Continuing to improve and enhance the organizational structure and operational capacity of pharmaceutical, food safety, and cosmetic management agencies.

Article 2Implementation organization:

1. Ministry of Health: leading and coordinating with relevant agencies and provincial people's committees under the central government to implement this Decision.

2. Ministry of Home Affairs: coordinating with the Ministry of Health to develop a proposal to improve the organizational structure to enhance effectiveness and ensure the efficiency of state management in pharmaceuticals, food safety, and cosmetics, submitting it to the Prime Minister for examination and decision.

3. Ministry of Finance, Ministry of Planning and Investment: coordinating with the Ministry of Health and relevant ministries and sectors to develop policies and plans for budget allocation and resource mobilization to implement the contents of the proposal.

4. Relevant ministries, sectors, and provincial people's committees under the central government, according to their assigned functions and tasks, are responsible for coordinating with the Ministry of Health in implementing the contents of the proposal.

Article 3. This Decision shall take effect fifteen days after its publication in the Official Gazette.

Article 4. The Ministers, Heads of ministerial-level agencies, Heads of agencies under the Government, Chairmen of provincial and municipal people's committees under the central government are responsible for enforcing this Decision./.