VIETNAM’S PHARMACEUTICAL IMPORTS INCREASED BY MORE THAN 24%

According to preliminary statistics from the General Department of Customs, in the first 6 months of 2024, our pharmaceutical import value reached 1.997.990.548 USD, an increase of 24,1% over the same period in 2023.

According to preliminary statistics of the General Department of Customs, pharmaceutical import turnover in June 6 reached 2024 USD, down 348.711.261% compared to May 1. Cumulatively in 5 months, our pharmaceutical import value reached 2024 USD, up 6% over the same period in 1.997.990.548.

According to preliminary statistics of the General Department of Customs, pharmaceutical import turnover in June 6 reached 2024 USD, down 348.711.261% compared to May 1.

To reduce the value of pharmaceutical imports and promote domestic production development, according to a representative of the Ministry of Health, Vietnam is focusing on improving research capacity and application of new drug production technology, promoting development. clinical pharmacy, strengthening supervision of safe and reasonable drug use… aiming to become a new medical science and innovation center in the region.

Specifically, in the National Strategy for developing Vietnam’s pharmaceutical industry to 2023 and vision to 2045, we are focusing on improving research capacity and applying available technology to produce generic drugs and drugs in dosage form. new, modern mechanism, aiming to become a manufacturing and processing center, receiving technology transfer of original brand-name drugs in the ASEAN region.
According to the Strategy, Vietnam strives to develop the domestic pharmaceutical industry to level 4 – the highest level, according to the World Health Organization’s classification.
By 2030, 100% of drugs will be provided proactively and promptly for disease prevention and treatment needs; ensure drug security, meet the requirements of national defense, security, disease prevention and control, overcome the consequences of natural disasters, disasters, public health incidents and other urgent drug needs.

Domestically produced drugs strive to meet about 80% of demand and 70% of market value; continue to strive to achieve the goal of producing 20% of raw material needs for domestic drug production.

Dr. Ta Manh Hung, Deputy Director of the Drug Administration of Vietnam (Ministry of Health), said that previously the average annual medicine cost per capita for a Vietnamese person was less than 5 USD, but now it has increased to 70 USD/person/year. and the pharmaceutical industry has basically met domestic drug demand.

In particular, Vietnam is considered one of the countries with the lowest rate of counterfeit drugs in the region. In recent years, substandard drugs have been maintained at a low level of less than 2% of the total number of samples taken on the market. While in the 1990s, the proportion of fake drugs on the market was more than 10%.

Regarding production, Vietnam has developed a large number of pharmaceutical enterprises. However, domestically produced drugs are not highly competitive.

More than 200 enterprises mainly produce generic drugs. There are more than 800 pharmaceutical substances circulating in the domestic market, but the number of pharmaceutical substances produced by domestic enterprises is less than 50%.

“The pharmaceutical industry still has some unachieved goals. Nearly 90% of raw materials for drug production are imported. The rate of drugs assessed as bioequivalent is low, only about 10%,” Mr. Ta Manh Hung analyzed.

Therefore, one of the goals of developing the pharmaceutical industry in the near future is to partially shift from producing generic drugs to patent drugs.

It is also expected that the Ministry of Health will submit a Law Project to amend and supplement a number of articles of the Pharmacy Law with a number of regulations to attract investment and further promote research, development and production of medicinal raw materials. promote the development of domestic drug production.

Mr. Nguyen Thanh Lam, Deputy Director of the Drug Administration (Ministry of Health) said that the Law Project amending and supplementing a number of articles of the Pharmacy Law has added a number of regulations to attract investment and further promote research and development for production of medicinal raw materials; Research and receive technology transfer for the production of high-tech drugs, biotechnology drugs, and specialized treatment.

Specifically, the Draft Law supplements special investment support regulations according to the provisions of law for research activities, technology transfer, investment in the production of pharmaceutical substances, new drugs, and original brand-name drugs. , specialized drugs, drugs applying high technology in the production of vaccines, biological products, rare drugs, drugs to prevent and control social diseases, herbal drugs and traditional drugs produced from Vietnamese medicinal materials under the brand name nation.

In addition, the Draft specifies investment incentives for the production of generic drugs, medicinal ingredients such as excipients and capsule shells; packaging in direct contact with drugs; Build biological testing facilities, evaluate bioavailability and bioequivalence of drugs; drug clinical trial facility.

At the same time, increase the corporate income tax incentive rate, increase the deduction rate and duration of use of the Science and Technology Development Fund, and import tax on medicinal materials that Vietnam has not yet produced.

In addition, output incentive policies (buying drugs, payment by health insurance, maintaining prices and reducing prices according to the roadmap…) for newly researched drugs and original brand-name drugs are intended to encourage transfer. technology to produce original brand-name drugs in Vietnam, increasing supply to meet people’s drug needs.

Also according to the representative of the Drug Administration, the Draft creates conditions to simplify documents for extension, change, and supplementation of registration papers for circulation of drugs and medicinal ingredients; stipulates that cases of extension, change, or supplementation of the circulation registration certificate do not have to go through the Advisory Council for granting the drug circulation registration certificate or do not have to wait for approval from the Ministry of Health to simplify administrative procedures.

Reduce the time to process changes and additional documents that only need to be announced from 3 months to 15 working days; Reduce the time limit for granting circulation registration from 12 months to 9 months in case of recognition and reference to speed up the licensing process and ensure people’s right to early access to drugs.

Allows establishments to continue using the circulation registration certificate after it expires and has submitted an extension application according to regulations until it is renewed or has a document from the Ministry of Health to ensure continuous circulation. of drugs and medicinal ingredients, avoiding market supply disruptions.

Do not continue to extend the validity of the circulation registration certificate for drugs and medicinal ingredients that have been granted a circulation registration certificate, but are not circulating on the market within the validity period of 5 years from the date of issuance, except rare drugs, drugs to treat rare diseases or drugs with no more than 3 valid circulation registration certificates of the same active ingredient, content and dosage form.

This is to limit the submission of dossiers not based on practical needs, reduce the handling of dossiers by management agencies as well as control the quantity of drugs and medicinal ingredients actually in circulation. distributed on the market, thereby having a clear view of drug supply capacity, supporting planning and forecasting.

The draft also decentralizes the authority to recall drugs to the Department of Health in case of mandatory recall of drugs that do not meet level 2 or level 3 quality standards discovered in the area, in order to promptly handle them. Manage and recall drugs that violate quality in the management area, ensuring safe and effective use of drugs.

Abolish procedures for confirming drug information content and requiring confirmation of drug information and advertising content to implement the plan to reduce and simplify administrative procedures approved in Decision No. 1661/QD -TTg dated October 4, 10 of the Prime Minister approving the plan to reduce and simplify regulations related to business activities within the scope of management functions of the Ministry of Health.

With the sharp reduction in administrative procedures mentioned above, according to Mr. Nguyen Thanh Lam, it will fundamentally solve the shortcomings and inadequacies in the state management of pharmaceuticals, helping the pharmaceutical industry continue to develop strongly, ensuring timely supply of quality, safe, effective and reasonably priced medicines to the people.

Source: Đầu Tư Online

About STELLAPHARM

Stellapharm J.V. Co., Ltd. is currently known as one of leading generics pharmaceutical companies and strong manufacturers in Vietnam. Established in 2000, Stellapharm was built on the foundation of a manufacturing factory in Vietnam and formed a joint venture with a partner from Germany. We focus on both prescription drugs and non-prescription especially in cardiovascular diseases, anti-diabetics drugs, etc. Products of Stellapharm are now used by millions of patients in more than 50 countries worldwide.

The company is globally recognized for its quality through our facilities have been audited and approved by stringent authority like EMA, PMDA, Taiwan GMP, local WHO and others.

Additional information for this article: Stellapharm J.V. Co., Ltd. – Branch 1
A: 40 Tu Do Avenue, Vietnam – Singapore Industrial Park, An Phu Ward, Thuan An City, Binh Duong Province, Vietnam
T: +84 274 376 7470 | F: +84 274 376 7469 | E: info@stellapharm.com | W: www.stellapharm.com