Thứ bảy, ngày 4/6/2016
BY 2025, DOMESTICALLY PRODUCED DRUGS WILL ACCOUNT FOR 75%

​       O​n March 17, 2021, the Prime Minister issued the Decision No. 376/QD-TTg approving the Program on development the pharmaceutical industry and domestically produced herbal ingredient until 2030 and vision to 2045

Accordingly, the specific objectives of the Program are:

By 2025

- Domestically produced drugs will account for 75% of the used quantity and 60% of the market value, the rate of using medicinal materials of domestic origin and drugs from domestic medicinal materials will increase at least 10% over 2020.

- Build 08 regions for sustainable exploitation of natural medicinal materials by 2025. To build 02 - 05 large-scale medicinal plant growing areas, each exploiting area or growing area having 01 - 02 chains of research, growing, processing and production of medicinal materials in compliance with the World Health Organization’s principles.

By 2030:

Domestically produced drugs account for 80% of used drugs and 70% of market value, percentage of domestic herbal ingredients and herbal drugs increases by at least 30% compared to 2020, at least 10 – 15 transplanted herbal drugs are developed to meet domestic demand. Reinvigorate, import, transplant and develop 10 – 15 foreign herbal ingredients in large quantity.

Transfer production technology of at least 100 innovator drugs with valid trademark, vaccines, medical biological and medicine which Vietnam has not been able to produce.

Become a high quality pharmaceutical production center in the region. Export value of domestically produced drugs achieves approximately USD 1 billion.

By 2045:

    Vietnam has innovator drugs originating from unique herbal ingredients which are researched, produced and registered for trademark. Total pharmaceuticals industry value contributes more than USD 20 billion to GDP.

To achieve the above objectives, it is necessary to implement the following tasks and solutions:

- Research and finalize applicable regulations and law to incentivize, assist and provide preferential treatment for pharmaceutical enterprises; Enterprises manufacturing innovator drugs shall receive benefits similar to hi-tech enterprises; Innovator drugs, generic drugs with modern dosage form and multivalent vaccines are considered hi-tech products; Provide preferential treatment in terms of tax, credit and land use policies (land rent, land rent duration) for enterprises and facilities investing in cultivation, processing, extraction of herbal ingredients and development of herbal drugs, traditional drugs.

- Review and finalize regulations on bidding and purchase of drugs produced in Vietnam, increase percentage and value of domestically produced drugs under list of drugs covered by health insurance; ensure promotion of domestic drugs is implemented as per the law.

- Adopt special promotions as per the law for: Research, transfer, production of pharmaceutical starting materials, especially biological pharmaceutical starting materials and pharmaceutical starting materials that utilize herbal ingredients with high economic value domestically; Construction and operation of bioequivalence testing centers, clinical testing centers, research centers for hi-tech drugs, herbal drugs, traditional drugs, national genetic resource and herbal ingredient research centers.

- Complete regulations on assuring effective protection of intellectual property rights for innovator drugs with valid trademark in Vietnam.

- Increase capacity of pharmaceutical authorities with organization model, functions and tasks similar to advanced countries and participate in Pharmaceutical Inspection Co-operation Scheme (PIC/S),  

- Implement EU-GMP standards or equivalent in production of hi-tech drugs; enable foreign enterprises to invest in upgrading domestic manufacturing facilities to EU-GMP standards or equivalent.

- Simplify administrative procedures and cut down conditions for business investment.   Increase provision of level 4 public services in pharmaceutical administration and prioritize GMP assessment, issuance of registration number for new drugs, and adoption of procedures for rapid appraisal and issuance of license for drugs subject to technology transfer for domestic production. 

- Continue to promote investment in research, testing and production of drugs. Plan and allocate land fund for construction of industrial parks to attract domestic and international investors for production of innovator drugs with valid trademark, specialized treatment drugs, generic drugs with hi-tech dosage form, vaccine, medical biological satisfying domestic and export demands.

- Mobilize all resources including domestic and international organizations and individuals to invest in developing drugs domestically, producing drugs subject to right transfer, drugs subject to technology transfer, vaccine, medical biologicals and products originating from herbal ingredients.    Prioritize investment and development of pharmaceutical chemistry program to produce pharmaceutical starting materials serving domestic drug production and reduce dependence on imported starting materials.

- Prioritize development of production projects for drugs subject to technology transfer and processed drugs as soon as patents or relevant trademark certificates expire.

- Implement drug distribution control and post-inspection affairs simultaneously.  Complete online connection of drug sale data from production, import, export, sale, retail and use, prioritize supervising quality, price, drug information and origin.

- Actively cooperate with international forums, organizations, diplomatic missions, pharmaceutical authorities of advanced countries around the world, international enterprises and enterprise associations in exchanging, sharing information, developing management, science, training and technical support affairs in pharmaceutical sector; prioritize cooperation with multi-national pharmaceutical corporation in researching and developing innovator drugs with valid trademark in Vietnam, transferring technology for production of generic drugs with hi-tech dosage form.   

- Actively negotiate, participate and implement international agreements in pharmaceutical sector. Develop roadmap for accreditation and moving toward mutual recognition in terms of drug registration and GMP assessment.

- Increase cooperation, connection and share of pharmaceutical administration database with pharmaceutical authorities. Promote harmonization of documents and procedures related to pharmaceutical administration as close to international standards as possible.

This Decision comes into effect from the day of signing.

For detail: QĐ 376.docQĐ 376.doc

Department of Enterprise Management.


DONG NAI INDUSTRIAL ZONES AUTHORITY
Address: No.26, 2A St., Bien Hoa II Industrial Zone, Bien Hoa city, Dong Nai Province, Viet Nam.
Tel: 84.251.3892378 - Fax: 84.25
1.3892379
Email: bqlkcn@dongnai.gov.vn, diza@diza.vn - Website: http://diza.dongnai.gov.vn
Chief Editor: Mr. Pham Van Cuong - Deputy Director