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【EXPERT Q&A】What certification is required for drug export to Vietnam?

Drugdu.com expert’s response: Exporting pharmaceutical products to Vietnam requires a series of certifications to ensure compliance with Vietnamese regulations and legal sale in the Vietnamese market. Here are the primary certification requirements: Ⅰ. Free Sales Certificate (FSC) from the Drug Regulatory Authority and Vietnam Embassy Authentication Free Sales Certificate (FSC) from the Drug Regulatory Authority: Definition: The Free Sales Certificate, also known as the Export Sales Certificate, is an official document issued by the drug regulatory authority, certifying that a particular pharmaceutical product or medical device meets relevant national standards and directives, allowing its free sale within the country and export to other countries. Role: In international trade, the FSC is a crucial document for enhancing a product’s international competitiveness, particularly when exporting to overseas markets like Vietnam, where it validates the legality and quality of the pharmaceutical products. Vietnam Embassy Authentication: Definition: Vietnam Embassy Authentication is an official certification ...
- Source: drugdu
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- October 16, 2024
Collaborating with 10 Indian AI startups

These measures are part of the business expansion plan launched by this Danish pharmaceutical company in Bangalore 17 years ago. The center helps manage a large amount of data collected regarding the safety and efficacy of its drugs, including clinical trial information and potential side effect reports. One of the factors driving this initiative is that the demand for obesity and diabetes related drugs is expected to grow, especially with the increasing global attention to these health problems. Through strategic positioning in India (one of the world’s largest diabetes drug markets), Novo Nordisk is expected to meet the growing demand by improving its production capacity. This partnership has also had a broader impact on the operations of Novo Nordisk. It is expected that Novo Nordisk’s Bangalore center will become an approximate mirror of its Danish headquarters within three years. The company plans to increase the number of employees in Bangalore ...
- Source: drugdu
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- October 16, 2024
460 million! Migraine innovative equipment company completes Series B financing

Recently, migraine innovative equipment company ShiraTronics announced the completion of a Series B financing of $66 million (approximately RMB 460 million) to support its innovative migraine treatment system. This round of financing is led by new investor Norwest Venture Partners, with other new investors including Seroba, OSF Ventures, Global BioAccess Fund, and an undisclosed strategic investor. In addition, some existing investors such as U S. Venture Partners, Amzak Health, Treo Ventures, and Aperture Venture Partners also participated in this round of financing. The world’s first medical device to treat migraine ShiraTronics, located in Minneapolis, Minnesota, is a clinical stage medical device company dedicated to developing neurostimulation therapies for chronic migraine patients. It is committed to improving the lives of chronic migraine patients and was awarded the FDA Breakthrough Device designation in 2021. The name migraine is not unfamiliar and is often heard in daily life, so the migraine market is ...
- Source: drugdu
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- October 16, 2024
Progress has been made in the construction of HSV-1 oncolytic virus where Wuhan virus is located

Recently, Hu Zhihong, Wang Manli, Luo Minhua and Zeng Wenbo from the Wuhan Institute of Virology, Chinese Academy of Sciences, jointly published a research paper entitled “Efficient Strategy for Synthesizing Vector Free and Oncolytic Herpes Simplex Type 1 Viruses” on the international academic journal ACS Synthetic Biology. This research carried out the construction and optimization of an artificial synthesis platform based on type I herpes simplex virus type F, and used this platform to transform oncolytic viruses. Type I herpes simplex virus (HSV-1) has important application prospects as an oncolytic virus in cancer treatment. In this study, the research team developed a new method for efficient synthesis and rescue of HSV-1 virus. Unlike traditional methods of synthesizing complete genomes containing vector sequences in vitro and transfecting them into mammalian cells to rescue viruses, the research team synthesized HSV-1 genome fragments containing homologous arms through transformation related homologous recombination (TAR) in ...
- Source: drugdu
- 71
- October 16, 2024
Pfizer’s innovative drug HYMPAVZI ™ Mataximab hncq has been approved by the FDA for the treatment of hemophilia A and hemophilia B

The approval of HYMPAVZI is based on the results of a phase III trial study, which showed that compared with factor based prophylaxis and on-demand treatment, the drug can significantly reduce bleeding rates in eligible hemophilia A and hemophilia B patients without inhibitors. HYMPAVZI is the first weekly subcutaneous injection regimen provided in the United States for eligible hemophilia B patients. At the same time, it is also the first regular treatment provided to eligible hemophilia A and hemophilia B patients through pre filled injection pens or syringes. Recently, Pfizer’s innovative drug HYMPAVZI ™ Mataximab hncq has been approved by the US Food and Drug Administration (FDA) for the regular treatment of hemophilia A (congenital factor VIII deficiency) or hemophilia B (congenital factor IX deficiency) patients over 12 years old without coagulation factor inhibitors, in order to reduce bleeding episodes. HYMPAVZI is the first and only approved anti tissue factor ...
- Source: drugdu
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- October 16, 2024
The “wolf” is really here, and the elimination of zombie approvals has begun

While the industry is still waiting to see whether the “zombie” approvals will really be eliminated, the new regulations of the National Medical Products Administration have provided a policy basis for the elimination of “zombie” approvals-On October 12, 2024, the National Medical Products Administration issued a notice on the application procedures and application materials requirements for re-registration of domestically produced drugs (No. 38 of 2024), which will be implemented from January 1, 2025. According to the new regulations on re-registration, three types of approvals will face the risk of delisting. The first type of risky products: “zombie” approvals, especially those with missing production scope and production address The “zombie” approvals mentioned above are very likely to be delisted: The “Application Procedures for Re-registration of Domestically Produced Drugs” clearly requires “strengthening the management of drugs that have not been produced on a commercial scale during the period from the approval of ...
- Source: drugdu
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- October 16, 2024
Important document! Secondary bargaining is “stopped”

Regarding the scope of the special rectification of “secondary bargaining” defined in the notice, the author consulted the relevant responsible personnel of the Finance Department of the Hunan Provincial Health Commission, and received the reply: This “secondary bargaining” rectification focuses on the behavior of public hospitals not settling according to the agreed purchase and sale prices in order to obtain irregular rebates. At present, most hospitals in Hunan Province are involved in “secondary bargaining” rebates to varying degrees and in different forms, such as bearing the cost of drug consumption fund recovery and deducting penalties for excessive drug use as the name and method of rebates. The rebate income from “secondary bargaining” is used by hospitals to supplement related operating costs. This time, the Hunan Provincial Health and Health System carried out a special rectification work on “secondary bargaining” of drug consumption, requiring it to be completed in October. In ...
- Source: drugdu
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- October 16, 2024
Yunnan Baiyao executive team adjustment

On October 11, Yunnan Baiyao issued the “Announcement on the Appointment of Senior Management Personnel”, appointing Li Shengli as its senior vice president. Li Shengli has held important positions in many pharmaceutical companies, including general manager, president, CEO, and chairman of Jiangsu Wanbang Pharmaceutical Marketing Biochemical Oncology Division, co-president, president, and chairman of Jiangsu Fosun Pharmaceutical Sales Co., Ltd., assistant to the president, vice president, senior vice president, executive president, and chief development officer of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. The joining of Li Shengli once again verified the change in Yunnan Baiyao’s talent training model, from internal talent training to the “internal training + external introduction” dual-channel talent model, to create a high-quality talent team that meets its future development needs. Pharmaceutical companies have established their own talent training and selection system, and the company and employees understand each other, have high loyalty, and there is almost no ...
- Source: drugdu
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- October 16, 2024
“Sniper War” of Star Targets of Lung Cancer

Recently, Ascentage Pharmaceuticals’ APG-2449 has obtained CDE approval and will conduct two registered Phase III clinical studies for the treatment of non-small cell lung cancer. APG-2449 is a small molecule FAK inhibitor independently developed by Ascentage Pharmaceuticals with oral activity. It is a third-generation ALK/ROS1 TKI and the first FAK inhibitor in China to be approved by CDE for clinical trials. This may mean that the node for domestic drugs to disrupt the ALK target pattern is getting closer and closer, and it also indicates that the next blockbuster product of China’s innovative drugs is on the way. The saying “He who gets lung cancer gets the world” is widely circulated in the field of tumors. Lung cancer is the leading cause of morbidity and mortality of malignant tumors in China. The large number of lung cancer patients has always been a must-fight place for pharmaceutical companies. This is also ...
- Source: drugdu
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- October 16, 2024
Africa Health

Organiser：Informa Markets Time：October 22 – 24, 2024 Address：19 Richards Drive Johannesburg Gauteng Midrand 1685 South Africa Exhibition hall：Gallagher Convention Centre Product range: Medical Devices: Laboratory equipment and configurations, emergency and transportation facilities, surgical equipment, nursing and monitoring equipment, etc. Medical Technologies: Orthopedic and rehabilitation technologies, medical building facilities and technologies, medical information and communication technologies, etc. Pharmaceuticals: Various types of finished pharmaceuticals, medicinal products, medical excipients, etc. Hospital Supplies: Disposable medical supplies, medical disinfectants, etc. Medical Supplies: Medical clothing and laundry technologies, nutritional meal preparation equipment, medical furniture, etc. About Africa Health： The Africa Health Exhibition in Johannesburg, South Africa, is the most significant healthcare event on the African continent. For many years, our mission and vision at Africa Health, aligned with the African Health Organization, have been to bridge the gap in healthcare business, knowledge, and skill development through meaningful connections, bringing the future of healthcare to ...
- Source: drugdu
- 120
- October 15, 2024

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