December 13, 2016

FDA Launches Mobile App to Provide Details of Drugs

The Taiwan Food and Drug Administration (TFDA) has launched a mobile app aiming to provide details of drugs via their barcode. The mobile app, Drug Scanner, aims to allow consumers to download and gather information about over-the-counter drugs by scanning the barcode on packaging. The mobile app provides all necessary details on the drugs. The… read more

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December 13, 2016

MHLW Releases Ordinance Designating Substances as Specified Drugs

Japan’s Ministry of Health, Labour and Welfare (MHLW) has published the ‘Ordinance to Specify New Substances as Specified Drugs.’ The designated substances are as follows: Ordinance Name Common Name N-Ethyl-1,2-diphenylethylamine Ephenidine, EPE, NEDPA 2-[(Dimethylamino)methyl]-1-(3-hydroxyphenyl)cyclohexanol O-Desmethyltramadol, O-DSMT N-(2-Fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4-yl)acetamide Ocfentanil, A-3217 Manufacture, importation, sale, possession, etc. of these substances shall be prohibited. It took effect on November… read more

December 13, 2016

FDA Releases Revised Guidelines on the Submission of Equivalence Evidence of Pharmaceutical Products

Philippine Food and Drug Administration (FDA) has released the ‘Revised Guidelines on the Submission of Equivalence Evidence for Registration of Pharmaceutical Products.’ The document establishes requirements for the submission of in vitro or in vivo equivalence evidence for the registration of the following pharmaceutical products: Traditional/herbal medicines Biological products Medical oxygen Veterinary drugs Stem cell… read more

December 13, 2016

FTC Releases Enforcement Policy on the Marketing Claims for OTC Homeopathic Drugs

December 13, 2016

FDA Finalizes Rule on Over-the-Counter Time and Extent Applications of Drugs

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