Who is the current leader of the Drug Administration of Vietnam?

Who is the current leader of the Drug Administration of Vietnam? (Internet image)

1. Who is the current leader of the Drug Administration of Vietnam?

Leaders of Drug Administration of Vietnam: including the Director and Deputy Directors.

The Director and Deputy Directors are appointed, relieved of duty, and dismissed by the Minister of Health in accordance with the provisions of law.

The Director General is responsible before the Minister of Health and before the law for all activities of the Department; The Deputy Director assists the Director, is assigned by the Director to take charge of a number of tasks, and is responsible to the Director and to the law for the assigned tasks.

(Clause 1, Article 3 of Decision 1969/QD-BYT)

Current leaders of the Drug Administration of Vietnam are:

- Director of Drug Administration of Vietnam: DSCKII. Vu Tuan Cuong.

- Deputy Director of Drug Administration of Vietnam: Dr. Ta Manh Hung, MSc. Nguyen Thanh Lam, Assoc.Prof.Dr. Le Viet Dung.

2. Organizational structure of the Drug Administration of Vietnam

The organizational structure of the Drug Administration of Vietnam includes:

- Office of the Department;

- Pharmaceutical Business Management Department;

- Drug Quality Management Department;

- Drug Registration Office;

- Drug Price Management Department;

- Legal Department - Integration;

- Cosmetics Management Department;

- Non-business units under the Department: Center for training and supporting pharmaceutical and cosmetic enterprises.

(Clause 2, Article 3 of Decision 1969/QD-BYT)

3. Operation and payroll of Drug Administration of Vietnam

- The Drug Administration of Vietnam operates under the head regime;

- The functions, tasks, and powers of the Office of the Department and the departments and organizations under the Department are defined by the Director on the basis of the functions and tasks of the Department. The relationship between the Bureau's Office, its divisions, and organizations shall be regulated by the Director;

- The appointment and dismissal of leadership positions in the Office of the Department, leaders of departments and organizations under the Department shall comply with the provisions of law;

- Heads of the Department, leaders of the Bureau's Office, and leaders of departments and organizations under the Department are entitled to allowances in accordance with the law.

- Payroll: The payroll of the Drug Administration of Vietnam is determined in accordance with the law on employment positions and adjusted according to the demand for job positions decided by the Minister of Health on the basis of the proposal of the Director of the Drug Administration of Vietnam.

(Clause 3, 4, Article 3 of Decision 1969/QD-BYT)

4. Tasks and powers of Drug Administration of Vietnam

(1) Development of policies and laws on pharmaceuticals and cosmetics

- Lead or participate in the formulation of strategies, policies, master plans, plans, schemes, and projects on the development of Vietnam's pharmaceutical industry to submit to the Minister of Health for approval or promulgation, or the Minister of Health to submit to the competent authorities for approval or promulgation;

- Preside over or participate in elaborating legal documents, professional regulations, and national technical regulations on pharmaceuticals and cosmetics to submit to competent authorities for promulgation;

- Assume the prime responsibility for, and coordinate with relevant units in, collecting opinions, reviewing, finalizing, and transferring them to the Ministry of Science and Technology for appraisal and publication of the National Standards on drugs and medicinal ingredients; submit to the Minister of Health for promulgation and update the Pharmacopoeia of Vietnam on the basis of the National Standards on drugs and medicinal ingredients;

- Assume the prime responsibility for, and coordinate with relevant units in, appraising and submitting to the Minister of Health for promulgation the Vietnam National Pharmacopoeia;

- Assume the prime responsibility for, and coordinate with the Administration of Traditional Medicine and Pharmacy in, formulating and submitting to the Minister of Health for promulgation the list of drugs and active ingredients on the list of substances banned from use in a number of industries and fields; the list of drugs and medicinal ingredients subject to special control; the list of rare drugs; the list of essential drugs; the list of non-prescription drugs;

- Assume the prime responsibility for, and coordinate with the Department of Planning and Finance and the National Center for Centralized Drug Procurement, to develop a list of domestically produced drugs that meet the requirements of treatment, drug prices, and supply capacity; the list of drugs for bidding; the list of drugs for concentrated bidding; the list of drugs eligible for price negotiation according to the provisions of law;

- Develop and promulgate according to its competence or submit to competent authorities for promulgation documents providing professional and technical guidance on pharmaceuticals and cosmetics and directing and guiding the implementation organization.

(2) Registration of the circulation of drugs and medicinal ingredients.

- Receive dossiers, organize the appraisal of dossiers of registration of circulation of drugs and medicinal ingredients; grant, extend, change, supplement, and withdraw the circulation registration certificate of drugs and medicinal ingredients in accordance with law;

- Issue, adjust, and withdraw the certificate of free sale of pharmaceutical products (CFS) and the certificate of pharmaceutical products (CPP) according to the provisions of law;

- Publicize the lists of drugs, medicinal ingredients, drug manufacturers, and medicinal ingredients in Vietnam according to the provisions of the law and publicize information related to the circulation and registration of drugs and medicinal ingredients.

(3) Clinical trials of drugs

- Submit to the Minister of Health for promulgation regulations on clinical data in the application for registration of circulation of drugs and medicinal ingredients;

- Coordinate with the Department of Science, Technology, and Training in formulating, amending, and supplementing regulations on clinical trials of drugs, submitting them to the Minister of Health for promulgation, and coordinating to guide the implementation.

(4) Management of pharmaceutical business, pharmacy practice

- Direct and implement the management of pharmaceutical business and pharmacy practice; the management of drugs and medicinal ingredients must be specially controlled;

- Receive dossiers, appraise, evaluate, and submit to the Minister of Health for grant, re-issue, adjustment of contents, and revocation of certificates of eligibility for pharmacy business for establishments that manufacture, export, and import drugs and medicinal ingredients; establishments providing preservation services of drugs and medicinal ingredients; establishments providing testing services for drugs and medicinal ingredients; establishments providing bioequivalence testing services of drugs as prescribed by law;

- Receive dossiers, organize the appraisal, grant, extend, change, supplement, and revoke permits for the export and import of drugs, medicinal ingredients, packages in direct contact with drugs, or standard substances according to the regulations of the Law;

- Receive dossiers, appraise, evaluate, and submit them to the Minister of Health for grant, re-issue, adjustment of contents, and revocation of pharmacy practice certificates in the form of examination as prescribed by law;

- Carry out the procedures for disclosing: Information related to drugs licensed to be imported in accordance with the provisions of law; The list of foreign establishments supplying drugs and medicinal ingredients into Vietnam shall be announced by the competent authority of the exporting country in accordance with law; List of wholesalers that buy drugs and medicinal ingredients from establishments that have the right to import but are not allowed to exercise the right to distribute drugs and medicinal ingredients in Vietnam;

- Approve orders for the purchase of narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients, and drug precursors in accordance with the law.

(5) Quality control of drugs and medicinal ingredients

- Direct and implement the state management of the quality of drugs and medicinal ingredients nationwide in accordance with law;

- Organize the assessment of meeting the requirements of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Storage Practices for drugs and medicinal ingredients (GSP); grant, adjust, and revoke GLP, GMP, and GSP Certificates in accordance with law;

- Organize the assessment of compliance with Good Manufacturing Practices (GMP) of foreign manufacturers of drugs and medicinal ingredients when registering for circulation in Vietnam according to the provisions of law;

- Decide according to its competence the suspension of circulation or withdrawal of drugs and medicinal ingredients; handle the recalled drugs and medicinal ingredients in accordance with law.

(6) Information management, drug advertising, pharmacovigilance, and safe and rational use of drugs

- Direct, manage, and organize the implementation of activities related to pharmacovigilance, monitoring of adverse reactions, and other drug-related information nationwide;

- Direct, guide, and implement the management of drug information and advertising nationwide;

- Organize the appraisal, issue, re-issue, and adjust the content of the certificate of drug information content, the written certification of drug advertisement contents according to the provisions of the law.

(7) Drug price management

- Implement the contents of state management of drug prices according to the provisions of law; receive, publicize, and review dossiers of declaration, re-declaration, change, and supplement information on drug prices in accordance with law;

- Coordinate with relevant units to implement measures to stabilize drug prices in accordance with the law.

(8) Hospital pharmacy work

- Assume the prime responsibility for, and coordinate with relevant units in, directing, guiding, and supervising drug supply, drug prices, and drug quality at medical examination and treatment establishments; the implementation of principles and standards of Good Storage Practice for drugs and medicinal ingredients (GSP);

- Coordinate with the Medical Examination and Treatment Administration and relevant units in guiding and directing the implementation of clinical pharmacy activities in medical examination and treatment establishments;

- Participate in and coordinate with the Medical Examination and Treatment Administration and relevant units in guiding the rational, safe, and effective use of drugs; perform other relevant functions in the state management of hospital pharmacy as assigned by the Minister of Health.

(9) Management of cosmetics

- Direct and guide the organization to comprehensively implement the state management of cosmetics;

- Receive dossiers, organize the assessment, and grant, re-issue, adjust, and revoke certificates of establishments meeting the principles and standards of good cosmetic manufacturing practice (CGMP); issue, adjust and withdraw the receipt number of the declaration of imported cosmetic products; approve changes to the published contents on the cosmetic product announcement sheet; issue, adjust, and withdraw cosmetic import orders according to the provisions of law. Decide, according to its competence, the suspension of circulation and recall of cosmetics in accordance with the provisions of law.

(10) Directing, professional guidance, inspection, inspection

- Direct and provide professional guidance on the implementation of state management of pharmaceuticals and cosmetics at the Departments of Health and pharmacy work in relevant ministries and branches in accordance with law;

- Carry out inspections, participate in specialized inspections, and handle violations of the law in the field of pharmaceuticals and cosmetics according to the provisions of the law;

- Coordinate with relevant agencies to detect, fight, and prevent acts of smuggling, commercial fraud, and fake, poor quality, unknown-origin drugs, medicinal ingredients, and cosmetics as prescribed by law.

(11) Other quests

- Assume the prime responsibility for or coordinate with relevant units in carrying out the work of information and communication on undertakings, policies, and activities on pharmaceuticals and cosmetics;

- Assume the prime responsibility for, and coordinate with the Department of Infrastructure and Medical Equipment and other relevant units in, managing the production and use of oxygen gas for medical use;

- Develop plans and organize the implementation of international cooperation and integration in the field of pharmaceuticals and cosmetics;

- Assume the prime responsibility for, and coordinate with relevant units in, performing the functions of the National Vaccine Agency (NRA) of the Ministry of Health;

- Assume the prime responsibility for, and coordinate with relevant units in, implementing the project that Vietnamese people give priority to using Vietnamese drugs;

- Coordinate with the Department of Planning and Finance to develop the list of drugs and medicinal ingredients for the national reserve and coordinate with relevant units to organize the implementation;

- Coordinate with the Administration of Traditional Medicine and Pharmacy in the management and development of medicinal herbs;

- Implement legal work, administrative reform, and the application of information technology in state management of pharmaceuticals and cosmetics; organize the implementation of the national single window and the ASEAN single window in the field of pharmaceuticals and cosmetics;

- Implement the regime of statistics, information, reports, and management of records and documents in the field of pharmacy and cosmetics as prescribed;

- Manage the assigned organization, cadres, civil servants, public employees, assets, and funds in accordance with the provisions of the law;

- Perform other tasks assigned by the Minister of Health.

(Article 3 of Decision 1969/QD-BYT)

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