Decision No. 154/2006/QD-TTg dated June 30, 2006 of the Prime Minister approving the Scheme on state management of pharmaceuticals, food hygiene and safety and cosmetics in the 2006-2015 period

DECISION

APPROVING THE SCHEME ON STATE MANAGEMENT OF PHARMACEUTICALS, FOOD HYGIENE AND SAFETY AND COSMETICS IN THE 2006-2015 PERIOD

THE PRIME MINISTER

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

Pursuant to the June 30, 1989 Law on Protection of the People's Health;

Pursuant to the June 14, 2005 Law on Pharmacy;

At the proposal of the Minister of Health,

DECIDES:

Article 1.- To approve the scheme on state management of pharmaceuticals, food hygiene and safety and cosmetics in the 2006-2015 period with the following principal contents:

1. Objectives: To improve the quality and effectiveness of state management of pharmaceuticals, food hygiene and safety and cosmetics in order to meet the requirements of people's health protection, care and improvement and international integration.

2. Objects governed by this scheme include drugs (modern medicines, vaccines, medical biologicals, traditional medicaments and medicines of materia medica origin), food hygiene and safety and cosmetics.

3. Major tasks:

a/ To further elaborate and perfect legal documents on state management of pharmaceuticals, food hygiene and safety and cosmetics from the central to local level.

b/ To strengthen and improve the capabilities of central and local agencies performing state management of pharmaceuticals, food hygiene and safety and cosmetics:

- At the central level: To reorganize, and improve the operation capability of, the Vietnam Drug Administration and the Food Hygiene and Safety Department; to promulgate a mechanism on coordina-tion among concerned units of the Health Ministry in performing state management of pharmaceuticals, food hygiene and safety and cosmetics.

- At the provincial/municipal level: To reorganize and strengthen agencies in charge of management of pharmaceuticals, food hygiene and safety and cosmetics; to define and perfect the functions and tasks of the centers for testing pharmaceuticals, food hygiene and safety and cosmetics.

- To perfect the organization and enhance the capability of inspectorates in charge of pharmaceuticals and food hygiene and safety.

c/ To work out a planning on the system of establish-ments for testing pharmaceuticals, food hygiene and safety and cosmetics from the central to local level:

- To further invest in upgrading the Central Drug Test Institute, the Ho Chi Minh City Drug Test Institute and the National Institute for Assessment of Vaccines and Medical Biologicals to reach international standards.

- To upgrade the Center for Testing Food Hygiene and Safety under the Nutrition Institute into a national institute for testing food hygiene and safety; the Food Test Faculty under the Ho Chi Minh City Hygiene and Public Health Institute into an international-standard center for testing food hygiene and safety.

- To establish three international-standard centers for testing drugs, vaccines, medical biologicals, food hygiene and safety and cosmetics in the northern mountainous region, Central Vietnam and the Mekong River delta region; to reorganize provincial/municipal centers for testing pharmaceuticals, food hygiene and safety and cosmetics.

d/ To build three international-standard centers for testing bioequivalence and assessing bioavailability of drugs in Hanoi, Da Nang and Ho Chi Minh cities for use as a basis for the rational choice and safe use of quality drugs.

e/ To consolidate, reorganize and invest in improving the material foundations and equipment of, two centers for drug information and monitoring drugs' adverse effects in Hanoi and Ho Chi Minh cities. To establish three regional centers in the northern mountainous region, Da Nang and Can Tho.

f/ To develop the source of officials managing pharmaceuticals, food and cosmetics; to enhance professional and managerial skills training and retraining for officials managing pharmaceuticals, food hygiene and safety and cosmetics.

g/ To define the organizational structures of agencies performing state management of pharmaceuticals, food hygiene and safety and cosmetics to suit Vietnam's development demand and specific conditions as well as regional and international integration trend.

4. Implementation solutions

a/ Mechanisms and policies:

- To elaborate and perfect legal documents, mechanisms and policies related to state management of pharmaceuticals, food hygiene and safety and cosmetics, particularly policies to encourage investment in and development of the production of pharmaceuticals, food and cosmetics and policies to support people living in deep-lying and remote areas and regions meeting with economic difficulties.

- To formulate mechanisms and policies to encourage and attract specialized managing officials with university or higher degree to work in localities, especially in deep-lying and remote areas.

b/ Investment and finance:

- To intensify investment in upgrading material foundations and technical equipment in service of state management of pharmaceuticals, food hygiene and safety and cosmetics at the central and local level. To computerize state management of pharmaceuticals, food hygiene and safety and cosmetics from the central to provincial and district level.

c/ Human resource training:

- To survey and evaluate the actual state of human resource in the domains of pharmaceuticals, food hygiene and safety and cosmetics, especially in the state management of these domains, which shall serve as a basis for devising plans for their rational and efficient training, retraining and employment.

- To provide knowledge of state management of pharmaceuticals, food hygiene and safety and cosmetics for managing officials from the central to local level.

- To draw up plans on training mountainous provinces' officials to obtain university degree in pharmacy, food and cosmetics; to intensify the training of district pharmacists to obtain university or intermediate degree, and commune pharmacists to obtain intermediate or primary degree.

- To formulate policies to prioritize and encourage officials working at grassroots medical establishments and in areas meeting with economic difficulties to take formal or short-term training courses on state management of pharmaceuticals, food hygiene and safety and cosmetics.

d/ Assurance of pharmaceuticals, food and cosmetics quality and safety:

- To promulgate and apply the Good Practices (GPs) principles compliant with the World Health Organization standards to the production, quality inspection, preservation, circulation and distribution stages at all establishments producing and/or trading in pharmaceuticals, food and cosmetics to meet the quality, efficiency and safety requirements.

- To promulgate Good Manufacture Practices standards applicable to oriental medicines and Good Practices standards for planting, harvesting and processing materia medica in order to supply materia medica up to standards for the manufacture of drugs.

- To issue standards of materia medica and drugs of materia medica origin in conformity with international and regional standards.

e/ International cooperation:

- To enhance cooperation with countries in the Asia-Pacific region and the world and with international pharmaceutical federations to gather market information and share managerial experience.

- To expand international cooperation in intensive management, economic and technical training related to pharmaceuticals, food hygiene and safety and cosmetics.

f/ Communication and education:

- To enhance communication and education in order to raise public awareness of the rational and safe use of drugs, food and cosmetics.

- To intensify propaganda about the quality of domestically produced drugs to overcome the people's mentality of preference for foreign and specific drugs.

- To intensify propaganda about safety and hygiene in food production, preservation, circulation and distribution.

- To promote coordination between state management agencies and the mass media in conducting propaganda and education related to pharmaceuticals, food hygiene and safety and cosmetics.

g/ Inspection, examination, and handling of violations:

- To strictly and regularly inspect and examine pharmaceuticals, food hygiene and safety and cosmetics. To review, amend or supplement regulations on sanctions against violations in the domains of pharmaceuticals, food and cosmetics.

- To renew and enhance coordination between inspectorates and functional agencies in stepping up inspection, examination, and handling of violations of subjects within the scope of their respective management according to the provisions of law.

5. Implementation schedule

a/ The 2006-2007 period:

- To evaluate the actual state of the system of organizations in charge of state management of pharmaceuticals, food hygiene and safety and cosmetics.

- To review, amend or supplement legal documents on pharmaceuticals, food hygiene and safety and cosmetics.

- To consolidate and raise the capability of state management of pharmaceuticals, food hygiene and safety and cosmetics from the central to local level.

- To invest in upgrading the Central Drug Test Institute, the Ho Chi Minh City Drug Test Institute and the National Institute for Assessment of Vaccines and Medical Biologicals to reach international standards; to upgrade the Food Test Faculty of the Ho Chi Minh City Hygiene and Public Health Institute into an international-standard food test center.

- To strengthen, reorganize and invest in improving the material foundations and equipment of, two centers for drug information and monitoring drugs' adverse effects in Hanoi and Ho Chi Minh cities.

b/ The 2008-2012 period:

- To continue reviewing, amending or supplemen-ting legal documents on state management of pharmaceuticals, food hygiene and safety and cosmetics.

- To establish three centers for drug information and monitoring drugs' adverse effects in the northern mountainous region, Da Nang and Can Tho.

- To establish three centers for testing drugs, vaccines, medical biologicals, food hygiene and safety and cosmetics in the northern mountainous region, Central Vietnam and the Mekong River delta region.

- To establish three international-standard centers for testing bioequivalence and assessing bioavailability of drugs in Hanoi, Da Nang and Ho Chi Minh cities.

- To establish the National Institute for Testing Food Hygiene and Safety.

c/ The 2013-2015 period:

To further improve the organization and operation of agencies managing pharmaceuticals, food hygiene and safety and cosmetics.

Article 2.- Organization of implementation

1. The Ministry of Health shall assume the prime responsibility for, and coordinate with concerned agencies and provincial/municipal People's Committees in, organizing the implementation of this Decision.

2. The Ministry of Home Affairs shall coordinate with the Ministry of Health in formulating a scheme on organizational consolidation for raising the effectiveness and ensuring the efficiency of operation of agencies performing state management of pharmaceuticals, food hygiene and safety and cosmetics, and submit it to the Prime Minister for consideration and decision.

3. The Ministry of Finance and the Ministry of Planning and Investment shall coordinate with the Ministry of Health and concerned ministries and branches in formulating policies and plans on allocating funds and mobilizing resources for the implementation of the scheme's contents.

4. Concerned ministries and branches and provincial/municipal People's Committees shall, according to their assigned functions and tasks, coordinate with the Ministry of Health in implementing the scheme's contents.

Article 3.- This Decision takes effect 15 days after its publication in "CONG BAO."

Article 4.- Ministers, heads of ministerial-level agencies, heads of government-attached agencies, and presidents of provincial/municipal People's Committees shall have to implement this Decision.