Dr. Truong Quoc Cuong Director-General MINISTRY OF HEALTH DRUG ADMINISTRATION OF VIET NAM

Part I: Amendment of Pharmaceutical Law Part II: Implementation of National Strategy for Pharmaceutical Sector Development up to 2020 and vision to 2030 Part III:Recommendations 9/9/20152

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 As directed by the National Assembly and the Government, under the valuable technical and supports of the World Health Organization (WHO) within the Biennial Workplan 2012 – 2013, the Ministry of Health completed the project on amendment of selected articles in the pharmaceutical law, which was submitted to the Government and National Assembly in 2013 according to the established procedure.  At the 28 th Meeting of the NA Standing Committee of the 13 th Term, the MoH already submitted the draft for comments. Nevertheless, to be in line with the new context, the Chairman of the NA required to underscore the issue of drug price control, pharmaceutical industry development and some other issues. The MoH, therefore, continues to expand the scope of application to become an amended Pharmaceutical Law. Cục Quản lý Dược-Bộ Y tế4

1. Elaboration and supplement of policies on pharmaceutical issues  Focusing investment in development of: - Preparation technology of generic drugs, vaccines, pharmaco-chemical industry, herbal drugs; - Establishment of Centers for bioequivalence assessment, research and production of novel drugs, application of advanced technologies, technology transfer, toll manufacture;  Supplementing policies on: rational, safe and efficacious use of drugs; promoting clinical pharmacy and pharmaco-vigilance; Cục Quản lý Dược-Bộ Y tế5

2. Supplement of a chapter on pharmaceutical industry  Identifying areas eligible for priorities related to pharmaceutical industry development; - Research and production of pharmaceutical starting materials locally; - Production of generic drugs, vaccines, biologics and herbal drugs; - Culturing herbal materials, conservation of genetic sources as well as rare and precious medicinal herbs. Cục Quản lý Dược-Bộ Y tế6

3. Amendment of regulations on drug price control Supplementing regulations on targeted drug price control: drug bidding and procurement, drug price declaration, negotiation, stabilization, posting, specific responsibility designation. Cục Quản lý Dược-Bộ Y tế7

4. Drug business Supplementing business type of clinical trial services, bioequivalence testing services. 5. Issuance of drug marketing authorization (MA) Specific regulation on format and maximum timeline for issuing MA as regards specific types of application: first-time application, application for extension, application for variations. Cục Quản lý Dược-Bộ Y tế8

6. Clinical pharmacy: regulations on clinical pharmacy to assure the rational use of medicines and optimization of therapeutic protocols. Thus, training and investment in premises and equipment are needed. 7. Clinical trial - Cases subject to full trial; cases eligible for full exemption, partial exemption; - Removal of regulation on 5-year circulation in the country of origin. Cục Quản lý Dược-Bộ Y tế9

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Pursuant to the Pharmaceutical Law No. 34/2005/QH11 and the directions in the amended Pharmaceutical Law Project, the MoH developed and submitted to the Prime Minister for approval of the National Strategy for Pharmaceutical Sector Development up to 2020 and vision to 2030 to be a basis for implementation of important and targeted short-term, medium-term and long-term tasks to undertake the mandates tasked by the National Assembly and Government. Cục Quản lý Dược-Bộ Y tế11

1.Adequate supply of quality and affordable drugs for preventive and curative care to align with the disease patterns and to timely meet requirements for public security, national defense, natural disasters, epidemics and other emergency demands; 2.Development of pharmaceutical industry with focus on investment to develop the production of quality and affordable generic drugs to gradually replace imported ones; to develop the pharmaco-chemical industry and to bring into play the potential and advantages of Vietnam to develop production of vaccines and herbal medicines.

3. Development of pharmaceutical sector towards specialization, modernization and enhanced competitiveness with countries in region and the world; development of a modern, professional and standardized system of drug distribution and supply; 4. Rational, safe and effective use of drugs and promotion of clinical pharmacy and pharmacovigilance; 5. Rigorous and effective management over all the stages of production, export, import, storage, marketing, distribution and use of drugs.

14 2. Specific objectives up to % of drugs will be supplied for preventive and curative care % of starting material will be produced for local drug production; local drugs will take up 80% of total drug consumption value of the year, out of which 30% will be herbal drugs; local vaccines will cover 100% of the EPI and 30% of demand for serviced vaccination.

% of local and imported generic drugs granted registration number will undergo bioequivalence and bioavailability assessment % of drug businesses under the drug distribution system shall comply with standards of good practices, 50% of drug quality control establishments and 100% of vaccines and biologics quality control establishments shall meet standards of good practices (GPs). OBJECTIVES OF DEVELOPMENT (2)

% of national and provincial hospitals will have clinical pharmacy units and 50% of district and private hospitals will have clinical pharmacy activities The ratio of pharmacist/10,000 persons will reach 2.5, 30% out of whom will be clinical pharmacists.

17 1.Policy and legislation development 2.Planning: pharmaceutical industry, drug distribution system, drug quality control system, BA/BE centers, herbal material development. 3.Inspection and organization refinement: total quality management; intensification of quality inspection and oversight; model of centralized management of pharmaceuticals, food products and cosmetics

4. Investment: local drug production, technology transfer, establishment of BA/BE centers; development of drug distribution system in disadvantaged areas; upgrading of pharmaceutical research institute; strengthening capacity of drug quality control system. 5. Science, technology, human resource and training: promotion of research and application of advanced pharmaceutical preparation technologies; enhancement of training for pharmaceutical sector, especially clinical pharmacists. 6. International cooperation and harmonization Cục Quản lý Dược-Bộ Y tế18

19 1.Pharmaceutical industry development 1.1. Implementation of GMP-PIC/S Planning the Vietnam-specific pharmaceutical industry development. 2. Development of drug distribution system: establishment of 05 drug distribution centers in 05 regions: Northern Mountainous Region, Northern Central Coast, Southern Central Coast – Central Highlands, Southeast Region, Southwest Region.

20 3. Drug quality improvement 3.1. Extension of generic list and BE roadmap; 3.2. Enhancement of capacity of available BE Centers; 3.3. Rearrangement of quality control system of drugs and products directly affecting human health; 3.4. Increased effectiveness of detection and recall of substandard drugs.

21 4. Enhancing access to essential drugs 5. Enhancing research, production and use of generics 6.Strengthened production of herbal material and drugs 7. Rational, safe and effective use of drugs and human resource development

22 8. Projects with focused investment Investing, upgrading and modernizing 02 BE Centers under NIDQC and HCMC IDQC; Establishment of 05 inter-provincial drug quality control centers Investing and upgrading NICVB to the international level; Establishment of 02 national research centers of biotechnology and bio-similar technology Establishment of National Clinical Pharmacology Center Upgrading 02 DI&ADR Centers; Investing in and upgrading National Institute for Pharmaceutical Research and Development.

23 9.Projects eligible for investment incentives 9.1. Period Development and implementation of technology transfer projects: research and production of essential drugs, generics, special APIs on the available production lines. Development and implementation of projects on upgrading production technology of vaccines and biologics production lines. Building 03 Inter-provincial BE Centers in the Northern Central Part, Southern Central and Southeast Region respectively. Projects on pharmaceutical packaging material production technology

24 9. Projects eligible for investment incentives (cont.) 9.2. Period Development and implementation of projects on production of novel drugs, vaccines and biologics that are beyond Viet Nam’s current capacity. Development and implementation of projects on developing pharmaceutical auxiliary material industry: carton, plastic, glass… packaging material.

Cục Quản lý Dược-Bộ Y tế25 9. Projects eligible for investment incentives (cont.) 9.2. Period Development and implementation of projects on production of high tech pharmaceuticals: vaccines, products derived from recombinant DNA technology, stem cell technology. PRIORITIES (7)

9/9/201526

 To WHO:  Continuation of technical and financial supports for the development of the amended Pharmaceutical Law within Biennial Workplan 2014 – 2015 and beyond: - Inviting international experts experienced of pharmaceutical law development to provide written comments or to work in person, especially on: pharmaceutical industry development, drug price control (bidding and procurement, price negotiation, drug price regulatory authorities, roles of health insurance in drug price control), clinical pharmacy, BA/BE, drug distribution model… - Development of sub-law documents guiding the amended Pharmaceutical Law enforcement: Decrees, Circulars … (2016, 2017) Cục Quản lý Dược-Bộ Y tế27

 To other international health development partners: Considering technical and financial supports for priorities: 1. Supporting the implementation of the National Strategy: -In 9 socio-economic regions -Time frame: 5 years. -Scope: Implementation of the activities specified under the Strategy to be in line with the actual situation of each locality. 2. Project on reinforcing rational, safe and efficacious sue of drugs - Consolidation and development of drug information and adverse reaction oversight: providing training and equipment for national, inter-provincial centers, hospitals. - Community-based communication and education;

3. Strengthening access to essential drugs - Access to essential drugs constitutes part of the MDGs and WHO’s development policy. -Proposal: A Project on enhancing access to essential drugs and capacity for pharmaceutical workers in rural, mountainous and insular areas. Cục Quản lý Dược-Bộ Y tế29

4. Drug quality improvement - A project on capacity building for 02 BE Centers; - A Project on investment in 03 institutes (institutes for drugs quality control, national institute for control of vaccines and biologics), 05 inter-provincial drug quality control centers to comply wit the international standards and to meet the requirement for drug quality inspection. Cục Quản lý Dược-Bộ Y tế30

5. Herbal material and herbal drugs Project on investment in intensive laboratory for herbal material and herbal drug research to contribute to promoting the strengths of the Viet Nam pharmaceutical sector (in seed research, GACP, extraction, isolation, pharmacological assessment, product development ) Cục Quản lý Dược-Bộ Y tế31

6. Vaccines Việt Nam is one of the few vaccine manufacturing countries and local vaccines now could basically meet the need for the EPI (12 vaccines for 10/12 diseases within the EPI) - Proposal: A Project on Investment in Research and Development of combination vaccines Cục Quản lý Dược-Bộ Y tế32

The Drug Administration of Viet Nam, as the focal point, will: - Collaborate with the ICD in scheduling and implementing procedures of mobilizing supports from health development partners through HPG forum; - Promptly recommend solutions and reporting to the MoH leaders the progress and outcomes from implementation of the tasks assigned; - Closely collaborate with health development partners in the implementation process; - Undertake monitoring, oversight and promotion of Strategy Implementation Plan.