On 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.doc
Department of Enterprise Management.