Proposal for 8 cases of traditional medicine exempted from clinical trials

Proposal for 8 cases of traditional medicine exempted from clinical trials

According to the draft, traditional medicines recognized by the Ministry of Health as exempt from clinical trials include medicines with origins, sources, and formulas in the following cases: Traditional medicinal herbs; Ancient prescriptions;

Traditional medicine has been granted a traditional medicine certificate according to the provisions of law, has effects and indications clearly showing the traditional medicine disease, has been tested for acute and sub-chronic toxicity to ensure safety and effectiveness;

Traditional medicines that have been exempted from clinical trials have had their dosage form changed but their ingredients, content, indications, effects and route of administration not changed; they have been tested for acute and subchronic toxicity to ensure safety and effectiveness.

The modified ancient prescription has documents and data to prove or analyze, justify the modification in accordance with the theory of traditional medicine.

In case of reduction, if the ingredients contain medicinal herbs on the list of toxic medicinal herbs issued by the Minister of Health, acute and subchronic toxicity must be tested to ensure safety and effectiveness.

Is a product belonging to a provincial-level or equivalent scientific research topic on traditional medicine that has been approved by the Provincial/Municipal Science Council and decided by the Provincial/Municipal People's Committee or approved by the Ministry in charge of the industry according to current regulations; has effects and indications that clearly demonstrate the traditional medicine disease and has been tested for acute and subchronic toxicity and pharmacological effects to ensure safety and effectiveness, except for new traditional medicines specified in Point a, Clause 1, Article 89 of the Law on Pharmacy.

Traditional medicines with indications based on clinical research data according to the regulations on clinical drug trials of the Ministry of Health have been granted a circulation registration certificate and circulated for 10 years or more, without detecting additional undesirable effects and adverse reactions of the drug or traditional medicines without clinical data have been granted a circulation registration certificate and circulated for 5 years or more, without detecting additional undesirable effects and adverse reactions of the drug or traditional medicines.

Modifications from prescriptions that have been granted a circulation registration certificate and circulated on the market for 5 years or more, except for traditional medicines with indications based on clinical research data according to regulations on clinical drug trials of the Ministry of Health, no additional unwanted effects and adverse reactions of the drug are detected; there are documents, data to prove or analyze, justify the modification in accordance with the theory of traditional medicine.

49.000 billion VND spent on cigarettes each year

The Central Institute for Economic Management organized a workshop on developing a strategy to adjust special consumption tax on tobacco products, contributing to the implementation of Vietnam's sustainable development goals.

At the workshop, Dr. Tran Thi Hong Minh, Director of the Central Institute for Economic Management Research, said that Vietnam is currently one of the countries with the highest rate of tobacco use in the world. world.

The impact of tobacco use is not only limited to public health but also places a heavy burden on the national health system. Therefore, the issue of reducing the rate of tobacco use becomes more urgent than ever.

In the context that Vietnam is facing health challenges caused by tobacco, special consumption tax is identified as an important tool to control the rate of use of these items.

Excise tax not only plays a role in curbing consumption rates but also creates an important source of revenue for the state budget.

However, to ensure the effectiveness of this policy, a comprehensive assessment and analysis of the micro-impact of the tax on consumers and different population groups is needed.

Sharing at the workshop, Deputy Director in charge of the Tobacco Harm Prevention Fund (Ministry of Health) Phan Thi Hai said that in Vietnam, it is estimated that the amount of money spent on cigarettes is up to 49.000 billion VND/year.

The cost of medical examination and treatment, loss of labor productivity due to illness and premature death caused by smoking is 108.000 billion VND, accounting for 1,14% of GDP. This cost is 5 times higher than the revenue from tobacco tax.

According to Ms. Phan Thi Hai, smoking, especially electronic cigarettes and heated tobacco products among teenagers, is increasing like an epidemic that we can completely prevent.

Currently, special consumption tax on the retail price of tobacco products in Vietnam accounts for only 38,8%, much lower than the recommendation of the World Health Organization (70-75% of the retail price).

Therefore, increasing tobacco taxes will significantly reduce access to tobacco, primarily among adolescents and the poor, while also reducing mortality and health losses.

HIV infection among homosexuals is on the rise

In Vietnam, in the first 9 months of 2024, there were 11.421 new HIV positive cases and 1.263 deaths.

Of the newly discovered HIV infections since the beginning of the year, 82,9% are men, mainly aged 15-29 (40%) and 30-39 (27,3%), with the highest proportion being men who have sex with men (42,2%).

According to a 2019 study by the Center for Technology Transfer in Addiction and HIV Treatment, Ho Chi Minh City University of Medicine and Pharmacy and Life Center in Ho Chi Minh City on MSM and transgender women (TGW) in Ho Chi Minh City and neighboring provinces, 50% of MSM/TGW use amphetamine-type stimulants, 70% use poppers.

Associate Professor, Dr. Do Van Dung, Head of the Faculty of Public Health, University of Medicine and Pharmacy, Ho Chi Minh City, said that chemsex increases the risk of health effects such as not being able to control behavior when affected by drugs and participating in risky behaviors (even if they regret it later). A small number practice higher-risk sex due to the influence of drugs...

Assoc. Prof. Dung warned that substance use during sex among MSM increases the risk of HIV infection because users often do not participate in HIV transmission prevention measures such as not using condoms, not adhering to ARV or PrEP use... during and after participating in chemsex.

In addition, many people have mental disorders that require treatment or are permanently affected… or even die from overdose.

Ms. Nguyen Thi Minh Tam, Head of the HIV Infection Prevention Department, Department of HIV/AIDS Prevention and Control, said that 3 years ago, there was an increase in HIV infections among MSM, especially related to unsafe sexual behavior due to substance use.

With the support of UNAIDS and UNODC, the HIV/AIDS Prevention and Control Department together with the University of Medicine and Pharmacy, Ho Chi Minh City, have begun developing a set of training materials on chemsex interventions for community outreach workers in Vietnam.