Latest

MIL-OSI Australia: Platinum Male Enhancer capsules

By   /  June 19, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, Internet Communications Technology, law, Legal, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Platinum Male Enhancer capsules

Source: Australian Therapeutic Goods Administration Safety advisory – Platinum Male Enhancer capsules pose a serious risk to your health and should not be taken. The Therapeutic Goods Administration (TGA) has tested a product labelled Platinum – Male Enhancer and found that: the capsules contain the undeclared substances sildenafil, sulfosildenafil and sulfoaildenafil consumers are advised that […]

Read More →
Latest

MIL-OSI Australia: Bulbao Male Enhancer tablets

By   /  June 19, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, Internet Communications Technology, law, Legal, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Bulbao Male Enhancer tablets

Source: Australian Therapeutic Goods Administration Safety advisory – Bulbao Male Enhancer tablets pose a serious risk to your health and should not be taken. The Therapeutic Goods Administration (TGA) has tested a product labelled Bulbao Male Enhancer and found that: the tablets contain the undeclared substances sildenafil, tadalafil and yohimbine consumers are advised that sildenafil, […]

Read More →
Latest

MIL-OSI Australia: Medicine GMP – revised fees and charges effective 1 July 2018

By   /  June 18, 2018  /  24-7, Aid, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, Business, Commerce, English, Health, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Medicine GMP – revised fees and charges effective 1 July 2018

Source: Australian Therapeutic Goods Administration From 1 July 2018, the revised fees and charges model for domestic medicine manufacturers will commence. The revised fees for Good Manufacturing Practice (GMP) clearance applications will be implemented July 2019. The revised fees and charges model is being implemented as a result of the Proposal to change the current […]

Read More →
Latest

MIL-OSI Australia: Comparable overseas regulators (CORs) for prescription medicines

By   /  June 15, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, Business, Canada, Commerce, English, Health, law, Legal, MIL OSI, Open Source Intel, Pacific Region, Singapore, Technology, Trade, United States of America  /  Comments Off on MIL-OSI Australia: Comparable overseas regulators (CORs) for prescription medicines

Source: Australian Therapeutic Goods Administration Criteria for identifying comparable overseas regulators (CORs) These criteria help identify opportunities for enhanced international collaboration in the regulation of prescription medicines. These criteria apply for both the work-sharing and COR report-based processes. The COR criteria are applied in two stages: Stage 1: The first stage sets out the preliminary […]

Read More →
Latest

MIL-OSI Australia: ACSS public statement, 27-28 October 2017

By   /  June 14, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, MIL OSI, New South Wales, Open Source Intel, Pacific Region, Technology  /  Comments Off on MIL-OSI Australia: ACSS public statement, 27-28 October 2017

Source: Australian Therapeutic Goods Administration ACSS Generic Medicines Working Group The ACSS Consortium Generic Medicines Working Group (GMWG) met in Brasilia, Brazil, on 27-28 October 2017. The purpose of this meeting was to advance information and work sharing arrangements in the assessment of generic drug applications. The focus of the meeting was the Generic Medicines […]

Read More →
Latest

MIL-OSI Australia: Valpam 5 (diazepam) 5 mg tablets

By   /  June 6, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Valpam 5 (diazepam) 5 mg tablets

Source: Australian Therapeutic Goods Administration Product defect alert – potential for blister strip to contain lower strength tablets Consumers and health professionals are advised that Arrow Pharma, in consultation with the TGA, has issued a product defect alert for one batch of Valpam 5 due to the possibility of the blister strip including white Valpam […]

Read More →
Latest

MIL-OSI Australia: Camellia sinensis (green tea) extract

By   /  June 5, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, Canada, English, Health, Media Intelligence, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Camellia sinensis (green tea) extract

Source: Australian Therapeutic Goods Administration Safety advisory – potential risk of harm to the liver Consumers and health professionals are advised that rare cases of harm to the liver have been associated with products that contain Camellia sinensis (green tea) extracts. Camellia sinensis (C. sinensis) is a herbal ingredient permitted for use in low-risk medicines […]

Read More →
Latest

MIL-OSI Australia: Advance notice – update to an eCTD file download for version 3.1

By   /  June 5, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Advance notice – update to an eCTD file download for version 3.1

Source: Australian Therapeutic Goods Administration The Therapeutic Goods Administration (TGA) intends to make a small amendment to the eCTD validation criteria. Specifically the amendment is to the current eCTD Document Matrix (Version 2.0) which is one of the file downloads for eCTD version 3.1 and which forms part of the validation criteria for both the […]

Read More →
Latest

MIL-OSI Australia: Dolutegravir

By   /  May 31, 2018  /  24-7, Aid, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Dolutegravir

Source: Australian Therapeutic Goods Administration Safety advisory – new study suggests possible risk of birth defects The TGA is closely monitoring the safety of dolutegravir after preliminary results from a new study suggested risk of birth defects in babies born to women being treated with this medicine. In the meantime, dolutegravir should not be used […]

Read More →
Latest

MIL-OSI Australia: Submissions received: Prescription strong (Schedule 8) opioid use and misuse in Australia – options for a regulatory response

By   /  May 23, 2018  /  24-7, Asia, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, Intelligence, MIL OSI, New Zealand, Open Source Intel, Pacific Region, South Australia  /  Comments Off on MIL-OSI Australia: Submissions received: Prescription strong (Schedule 8) opioid use and misuse in Australia – options for a regulatory response

Source: Australian Therapeutic Goods Administration The TGA thanks respondents who provided submissions in response to the February 2018 public consultation paper Prescription strong (Schedule 8) opioid use and misuse in Australia – options for a regulatory response. A total of 93 submissions were received, which comprised: 15 submissions from government bodies 6 submissions from industry […]

Read More →