Renewal of 1,500 registration certificates for circulation of drugs and pharmaceutical ingredients

During the renewal of drug and pharmaceutical ingredient registration certificates, the Ministry of Health recently granted registration certificates for 1,500 domestically produced drugs and ingredients to serve the needs of medical examination and treatment and epidemic prevention.

Medical news on December 23: Extension of 1,500 registration certificates for circulation of drugs and pharmaceutical ingredients

During the renewal of drug and pharmaceutical ingredient registration certificates, the Ministry of Health recently granted registration certificates for 1,500 domestically produced drugs and ingredients to serve the needs of medical examination and treatment and epidemic prevention.

Ensure quality standards and legal regulations

This extension includes 1,095 domestically produced drugs and ingredients that are granted circulation registration certificates valid for 5 years; 335 drugs that are extended for 3 years; and 57 drugs that are valid until December 31, 2025.

As of December 2024, the Ministry of Health has granted circulation registration certificates for more than 23,000 valid drugs.

The Drug Administration of Vietnam requires drug manufacturing and registration establishments to manufacture drugs in accordance with the dossier registered with the Ministry of Health, and to print or affix the registration number issued on the drug label. Establishments are only allowed to manufacture and put into circulation special controlled drugs when they have a Certificate of Eligibility for Pharmaceutical Business in accordance with the provisions of law.

In addition, drug manufacturing and registration establishments must update drug quality standards according to Circular No. 11/2018/TT-BYT and ensure that drug labels and instructions for use are updated according to Circular 01/2018/TT-BYT within 12 months from the date the circulation registration certificate is renewed.

This year, the Ministry of Health has organized 17 renewals of drug and pharmaceutical ingredient registration certificates. The total number of drugs and ingredients to be renewed in 2024 is up to 13,900, including 10,702 domestically produced drugs, 2,946 imported drugs and 252 vaccines and biological products.

As of December 2024, the Ministry of Health has granted circulation registration certificates for more than 23,000 valid drugs. Along with that, nearly 14,000 orders of drugs and pharmaceutical ingredients have been imported in 2023 and the first 11 months of 2024 to ensure adequate supply for medical examination and treatment needs.

The Drug Administration also requires drug manufacturing facilities to maintain operating conditions throughout the validity period of the circulation registration certificate. If the facility no longer meets the conditions, it must change the registration facility within 30 days.

Along with that, manufacturing facilities must coordinate with treatment facilities to monitor the safety, effectiveness and unwanted effects of drugs on users, and report results according to regulations.

Renewing drug registration certificates is an important step to ensure drug quality, while creating conditions for medical facilities and hospitals to have enough medicine to serve people and effectively prevent epidemics.

Ho Chi Minh City monitors and prevents strange disease from Congo

According to information from the World Health Organization (WHO) and the Africa Center for Disease Control (Africa CDC), an outbreak of an unknown disease is occurring in the Panzi area, Kwango province, Democratic Republic of Congo (DRC).

As of December 12, 2024, 527 cases have been reported, including 32 deaths (6% mortality). Symptoms include fever, headache, cough, runny nose, and muscle pain. Children account for the majority of cases (53% and 54.8% of deaths under 5 years of age). All severe cases have severe malnutrition.

The Panzi region, where the outbreak began, is a remote rural area in Kwango province, a long way from the capital Kinshasa. It is an area with poor health care, low vaccination rates, and severe food shortages.

There are currently about 25.6 million people in the Democratic Republic of Congo living in food insecurity, of which nearly 4.5 million children are severely malnourished. Malnourished children are susceptible to serious complications from infectious diseases, leading to death.

WHO assesses the risk level in the area of ​​the outbreak (Panzi, Kwango Province) as high, however, at the country level (DR Congo), the risk is classified as medium due to the local nature of the outbreak. At the regional and global levels, WHO assesses the risk of spread as low, however, it still notes surveillance at the border with neighboring Angola.

In Ho Chi Minh City, Tan Son Nhat International Airport has no direct flights from the Democratic Republic of Congo. Passengers from this region will have to transit through other countries before arriving in Ho Chi Minh City.

The international airports of the Democratic Republic of Congo (such as Ndjili, Lubumbashi, Goma and Bangoka International Airports) are not in the areas currently affected by the outbreak as reported by WHO. In addition, the sea routes from the Democratic Republic of Congo to Ho Chi Minh City have long transit times, which helps to detect and control the outbreak promptly.

The Ho Chi Minh City Department of Health has directed the Ho Chi Minh City Center for Disease Control (HCDC) to closely monitor the epidemic's developments and prepare response plans appropriate to each level of risk.

In particular, HCDC has an international health quarantine department on duty 24/7 at Tan Son Nhat airport and Ho Chi Minh City seaport to control the risk of disease entering from abroad.

HCDC will activate the early warning surveillance system at medical facilities and in the community. The network of community health collaborators covering all districts and Thu Duc city will continue to strengthen the monitoring and notification of the epidemic situation.

Medical facilities will be guided in implementing disease prevention measures, triaging treatment and admitting patients when suspected.

The Ho Chi Minh City Department of Health recommends that people should not travel to epidemic areas unless necessary. For those who have traveled to epidemic areas, if they detect suspicious symptoms, they should immediately go to a medical facility and provide full information about their travel history for timely diagnosis and treatment, while minimizing the risk of spreading in the community.

Ho Chi Minh City Center for Disease Control (HCDC) will continue to monitor and coordinate with WHO and relevant authorities to be ready to respond, in order to protect public health.

Ministry of Health streamlines apparatus, reforms administrative procedures

Deputy Minister of Health Le Duc Luan said that the Ministry of Health is continuing to improve and reorganize its apparatus in a streamlined and efficient manner, with the goal of improving the effectiveness and efficiency of state management in the health sector.

Within the framework of implementing Resolution No. 18-NQ/TW, the Ministry of Health has summarized and developed a project to reorganize and streamline the apparatus, including taking over a number of tasks from other ministries and branches.

Specifically, the Ministry of Health has taken over the management of social protection, children, and social evils prevention from the Ministry of Labor, War Invalids and Social Affairs, along with the development of a draft Decree regulating the functions, tasks, and organizational structure of the Ministry.

The Ministry of Health has also submitted to the Government the establishment of the National Medical Council, the National Steering Committee for the development of the Vietnamese pharmaceutical industry for the period 2021-2030, with a vision to 2045, and the consolidation of the National Steering Committee for Population and Development.

Currently, the Ministry of Health is continuing to complete a number of important projects, including: Project on arranging hospitals under the Ministry of Health for the period 2023-2030, Project on establishing the Central Disease Control Agency, and regulations on commune, ward and town health.

At the same time, the Ministry of Health is actively implementing administrative reform procedures to reduce paperwork and simplify administrative procedures for people and medical facilities.

In 2024, the Ministry of Health focused on removing bottlenecks in healthcare, especially in the areas of procurement, bidding for drugs, medical supplies, and prices of medical examination and treatment services.

The ministry has completed the implementation of 35 out of 69 administrative procedures in the health sector, reaching a rate of 50.7%. These administrative procedures have been made public on the National Database, reducing 94 administrative procedures compared to 2023.

In 2025, the Ministry of Health will continue to implement key tasks to perfect the organizational structure in the direction of "streamlining - compactness - strength - efficiency". The Ministry will continue to implement important projects such as the Health Facility Network Planning for the period 2021-2030 and the Project to rearrange hospitals under the Ministry of Health.

In addition, the Ministry of Health will promote administrative reform, decentralization and delegation of power, and improve the capacity of medical staff; continue to coordinate with the Ministry of Labor, War Invalids and Social Affairs to carry out tasks related to social protection, children and social evil prevention.

Deputy Minister Le Duc Luan emphasized that the Ministry of Health will continue to strengthen inspection, examination and supervision to ensure that the set tasks and goals are effectively implemented.

Source: https://baodautu.vn/tin-moi-y-te-ngay-2312-gia-han-1500-giay-dang-ky-luu-hanh-thuoc-nguyen-lieu-lam-thuoc-d234271.html