Significant differences on submission lag following regulation reform for registration of novel therapeutic drugs in Taiwan.

Drug lag, which delays patients' access to medicinal products, is typically associated with pharmaceutical regulations. To shorten drug lag, health authorities may establish new policies to liberalize the regulations, a step that is important in countries, such as Taiwan, with consumer demand for imported novel therapeutic agents. Taiwan's government enacted Articles 38-1 and 38-2 of Regulations for Registration of Medicinal Products to relax the regulatory barriers for new drug submission, thus conditionally exempting the requirement for the Certificate of Pharmaceutical Product (CPP).

Analysis of refuse-to-file policy for generic drug application in Taiwan.

Generic drugs are accounted for majority of medicinal products. To reduce the unnecessary review for incomplete dossiers of generic drugs, Taiwanese government launched a refuse-to-file (RTF) process since 2017. The present study aimed to examine the outcome of RTF process by analyzing application characteristic, RTF rate and deficiencies found in the submitted dossiers.

Advantages of using an abbreviated dossier for drug master file applications in Taiwan.

In Taiwan, the quality of active pharmaceutical ingredients is recorded in a drug master file (DMF), the applications for which can be submitted in two dossier types, either full (complete technical information) or abbreviated (partially complete technical information with an approved document issued by developed countries). However, the advantages of the abbreviated approach remain unknown. This study compared full and abbreviated dossier profiles and reviewed their outcomes in acceptance rates and deficiencies leading to rejection.

Effect of regulation reform on clinical trials for registering novel therapeutic agents in Taiwan: a chronological analysis.

The registration process for new drugs is crucial in the clinical application of medicines. Previously, the registration of imported novel therapeutic agents in Taiwan depended considerably on their approvals in developed countries. The Taiwanese government enacted Article 38-1 of the Regulations for Registration of Medicinal Products in September 2009.

Helicobacter pylori stool antigen test in patients with bleeding peptic ulcers.

Background: Helicobacter pylori has been linked to chronic gastritis, peptic ulcers, gastric cancer and mucosa-associated lymphoid tissue lymphoma. Invasive tests are less sensitive than noninvasive tests in diagnosing H. pylori infection in patients with bleeding peptic ulcers.

Helicobacter pylori cagA, iceA and vacA genotypes in patients with gastric cancer in Taiwan.

Aim: Helicobacter pylori (H pylori ) has been linked to chronic gastritis, peptic ulcer, gastric cancer and MALT-lymphoma. The link of genotypes of H pylori to gastric cancer remains controversial. The aim of this study was to investigate the H pylori vacA alleles, cagA and iceA in patients with gastric cancer in Taiwan.

Genotypes of Helicobacter pylori in patients with peptic ulcer bleeding.

Aim: Helicobacter pylori causes chronic gastritis, peptic ulcer, gastric cancer and MALT-lymphoma. Different genotypes of Helicobacter pylori are confirmed from diverse geographic areas. Its association with bleeding peptic ulcer remains controversial.

Helicobacter pylori cagA, iceA and vacA status in Taiwanese patients with peptic ulcer and gastritis.

Background: Helicobacter pylori causes chronic gastritis, peptic ulcer, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma. Different genotypes of H. pylori are confirmed from diverse geographical areas.

Plant-derived terpenoids and analogues as anti-HIV agents.

The plant-derived terpenoids and analogues are reviewed with respect to their anti-HIV activity, structure-activity relationships, and mechanism of action. The active compounds include diterpenoid lactones, phenolic diterpenes, atisane and kaurane diterpenes, phorbol diterpenes, triterpene glycosides, friedelane triterpenes, taraxerane triterpenes, ursane triterpenes, lanostane triterpene, lupane triterpenes, seco-ring A triterpenes, degraded triterpenes, and cucurbitacin triterpenes. Positive new leads for drug development will be highlighted.

Anti-AIDS agents 49. Synthesis, anti-HIV, and anti-fusion activities of IC9564 analogues based on betulinic acid.

The betulinic acid derivative IC9564 inhibits human immunodeficiency virus (HIV)-1 entry. Among a series of IC9564 derivatives, 5 and 20 were the most promising compounds against HIV infection with EC(50) values of 0.33 and 0.