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【EXPERT Q&A】What is the export procedure of proprietary Chinese medicine?

Drugdu.com expert’s response: To successfully export proprietary Chinese medicines, the following processes are required: I. Preliminary Preparations Understanding Target Market Regulations: Prior to exporting traditional Chinese medicines (TCMs), enterprises must conduct thorough research on the relevant regulations of the target market, including import registration requirements, quality standards, and certification systems. This information is crucial for ensuring the smooth entry of TCMs into the target market. Product Preparation: a. Ensure that the exported TCMs comply with relevant quality standards and possess valid drug production licenses and drug registration certificates issued by the national drug regulatory authority. b. Prepare product specifications, labels, packaging, etc., ensuring they comply with the regulatory requirements of the target market. Finding Partners: Identify suitable partners, such as importers, agents, or distributors. Selecting the right partners can help enterprises better understand the target market and reduce export risks. II. Preparation of Application Materials Basic Information of Medicines: Detailed information on the TCMs ...
- Source: drugdu
- 98
- August 20, 2024
Novel Test Identifies Patients at High Risk of Esophageal Cancers

Barrett’s esophagus is a precancerous condition where chronic acid reflux damages the esophageal lining, increasing the risk of progressing to esophageal cancer or high-grade dysplasia. Currently, about 90% of patients with Barrett’s esophagus undergo endoscopic surveillance every three to five years. However, this frequency may not be sufficient to catch some cancerous changes early. It’s estimated that up to 25% of patients progress to high-grade dysplasia or esophageal cancer before their next scheduled endoscopy, missing crucial early treatment opportunities. Common treatments include radiofrequency ablation or endoscopic resection to eliminate abnormal cells before they turn cancerous. Now, a novel test could significantly aid gastroenterologists in identifying which patients with Barrett’s esophagus are more likely to develop esophageal cancer, thus optimizing surveillance and management strategies. This innovative test, named Esopredict, is a PCR-based test that evaluates DNA methylation changes in the genes RUNX3, p16, HPP1, and FBN1 from biopsy samples. DNA methylation ...
- Source: drugdu
- 84
- August 20, 2024
Mouthwash-Based Test Could Predict Head and Neck Cancer Recurrence

Head and neck cancers comprise close to 4% of all cancer cases in the U.S., predominantly affecting individuals over the age of 50. Men are over twice as likely to develop this type of cancer compared to women. The primary treatments, surgery and radiation, can severely impact functions such as speech, swallowing, and physical appearance, significantly diminishing the quality of life. These impacts can intensify with cancer recurrence, which is challenging to detect as it is hard to distinguish between normal post-treatment changes and a recurrence of the cancer. Early detection of recurrence could greatly reduce the severity of outcomes for patients. Now, a new test using a simple mouthwash to detect biomarkers shows promise in predicting disease recurrence in patients with head and neck cancer. A previous study by researchers at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine (Miami, FL, USA) explored how ...
- Source: drugdu
- 81
- August 20, 2024
FDA Grants 510(k) Clearance to Cresilon’s Traumagel for Temporary External Control of Moderate to Severe Bleeding

By Don Tracy, Associate Editor Cresilon works to stop life-threatening bleeding in seconds, offering a valuable tool for military, emergency medical services, and healthcare professionals. The FDA has granted 510(k) clearance to Traumagel, Cresilon’s plant-based gel designed for temporary external control of moderate to severe bleeding. According to the company, the gel is expected to be a valuable tool for military, emergency medical services, and healthcare professionals. Additionally, Cresilon stated that Traumagel requires no preparation and is effective across all types of bleeds.1 “The ability to rapidly stop bleeding at the point of care and halt a life-threatening hemorrhage can be the difference between life and death for people with traumatic injuries,” said Joe Landolina, CEO, co-founder, Cresilon, inventor of the technology, in a press release. “The FDA clearance for Traumagel is a monumental milestone for Cresilon and brings us another step forward in our mission to save lives and ...
- Source: drugdu
- 69
- August 20, 2024
FDA Authorizes First At-Home, OTC Diagnostic Test for Syphilis

NOWDiagnostics’ First to Know has FDA De Novo marketing authorization as a new test for syphilis. The at-home product needs only a single drop of blood to test for this sexually transmitted infection. By Frank VinluanSyphilis testing typically requires obtaining a blood sample and sending it to a lab. The wait for results ranges from hours to days. The FDA has authorized a new at-home syphilis test, a NOWDiagnostics product that yields results within 15 minutes. The FDA said Friday that its marketing authorization for the NOWDiagnostics test makes the kit the first at-home, over-the-counter test for syphilis. Springdale, Arkansas-based NOWDiagnostics, or NOWDx, will market its new syphilis test as First-to-Know. Syphilis is caused by a bacterium, Treponema pallidum. It’s treatable with antibiotics, such as penicillin. Untreated, syphilis infection can damage the heart and the brain. This infection can also cause blindness, deafness, and paralysis. Reports of this sexually transmitted ...
- Source: drugdu
- 112
- August 20, 2024
Pfizer and BioNTech’s Covid-19/flu combination vaccine falters in Phase III readout

Pfizer and BioNTech have announced that a Phase III trial studying their investigational combination mRNA vaccine for the treatment of influenza and Covid-19 has failed to meet one of its two primary endpoints. While the vaccine demonstrated a trend of higher responses in neutralising the influenza A strain compared to a licensed influenza vaccine, it failed to demonstrate non-inferiority against the influenza B strain in geometric mean titers (GMT) and seroconversion, as per a 16 August press release. Additionally, data indicated that the combination vaccine showed “comparable” responses for SARS-CoV-2 when compared to Pfizer’s licensed approved Covid-19 vaccine, Comirnaty (tozinameran). The randomised, parallel assignment Phase III study (NCT06178991) enrolled over 8,000 adults aged 18 to 64 years old to evaluate the safety, tolerability, and immunogenicity of a single dose of the combined vaccine for protection against influenza and Covid-19. No new safety signals were found in the Phase III study. ...
- Source: drugdu
- 81
- August 20, 2024
AstraZeneca wins approval for Imfinzi in NSCLC perioperative setting

AstraZeneca’s Imfinzi (durvalumab) plus chemotherapy has secured US Food and Drug Administration (FDA) approval for non-small cell lung cancer (NSCLC) in the perioperative setting, just weeks after the agency called for an overhaul of perioperative lung cancer trials. This approval is for patients with resectable early-stage (IIA-IIIB) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients are treated in the perioperative setting – a term that refers to the time before, during, and after surgery. In a 25 July meeting, the FDA’s Oncologic Drugs Advisory Committee (ODAC) raised concerns about the design of trials done in this setting. The Imfinzi approval is based on positive data from the Phase III AEGEAN study (NCT03800134), which showed that the perioperative use of the treatment reduced the risk of cancer returning, progressing, or causing death by 32% compared to using chemotherapy alone. ...
- Source: drugdu
- 92
- August 20, 2024
McMaster drug trial receives more than $6m to test smallpox vaccine against mpox

Researchers from McMaster University have received $6.7m from the Coalition for Epidemic Preparedness Innovations (CEPI) and the Canadian Institutes of Health Research to assess the effectiveness of a smallpox vaccine in providing protection against mpox after post-exposure. Beginning in August, the Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial (SMART) will assess the effectiveness of the Bavarian Nordic smallpox vaccine, MVA-BN, in more than 1,500 participants in households with laboratory-confirmed mpox infection at sites in the Democratic Republic of Congo (DRC), Uganda and Nigeria. Mpox is a disease caused by infection with a virus known as the monkeypox virus, which is part of the same family as the virus that causes smallpox. Symptoms include fever and headache, as well as painful lesions. In some cases, the disease can lead to bronchopneumonia, sepsis, encephalitis, loss of vision and even death. In the DRC, between June 2023 and 2024, ...
- Source: drugdu
- 70
- August 20, 2024
Study identifies new disease-inducing mechanism for inflammatory bowel disease

Researchers from Newcastle University, Great North Children’s Hospital, Cambridge University Hospital and the universities of Cambridge and Oxford have identified a new disease-inducing mechanism for inflammatory bowel disease (IBD). The study published in the New England Journal of Medicine found that self-directed antibodies attacked interleukin-10 (IL10), an anti-inflammatory protein that controls intestinal immunity, in two patients with early-onset severe IBD. Collectively known as IBD, Crohn’s disease and ulcerative colitis are incurable conditions that involve excessive inflammation in the gut and affect over 500,000 people in the UK, according to Crohn’s & Colitis UK. Supported by the National Institute for Health and Care Research (NIHR), Cambridge Biomedical Research Centre, NIHR Oxford BRC and the Leona M. and Harry B. Helmsley Charitable Trust, and part-funded by the Wellcome Trust, scientists discovered that these antibodies prevented IL10 from binding to its receptor, ultimately causing an increased inflammatory response in patients. The team found ...
- Source: drugdu
- 101
- August 20, 2024
FDA Grants Accelerated Approval to Gilead’s Livdelzi for the Treatment of Primary Biliary Cholangitis

By Don Tracy, Associate Editor Approval of Livdelzi is based on results from the Phase III RESPONSE study, which demonstrated improved key biochemical markers and reduced pruritus. The FDA has granted accelerated approval to Livdelzi (seladelpar), Gilead’s treatment for primary biliary cholangitis (PBC) in adults who either have an inadequate response to ursodeoxycholic acid (UDCA) or cannot tolerate it. According to the company, the approval was based on positive results from the Phase III RESPONSE study, where Livdelzi significantly improved key biochemical markers and reduced pruritus, a debilitating symptom of PBC. Accelerated approval was based on a reduction of ALP.1 “More people are being diagnosed with PBC, impacting people of varied ages, gender, race and ethnicity. Those living with PBC share common symptoms, including incessant itching or skin-crawling sensations, as well as debilitating fatigue that is made worse by the itching at night,” said Carol Roberts, president, The PBCers Organization, ...
- Source: drugdu
- 136
- August 19, 2024

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