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The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia. It is a Division of the Australian Department of Health established under the Therapeutic Goods Act 1989 . The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner. Wikipedia.

Francis D.P.,Global Solutions for Infectious Diseases | Grohmann G.,Therapeutic Goods Administration
Vaccine | Year: 2011

In May 2006, the WHO published a Global Pandemic Influenza Action Plan. A significant part of that plan involves the transfer of technology necessary to build production capacity in developing countries. The WHO influenza technology transfer initiative has been successful. Clearly the relatively small WHO investments made in these companies to develop their own influenza vaccine production facilities have had quite dramatic results. A few companies are already producing large amounts of influenza vaccine. Others will soon follow. Whether they are developing egg-based or planning non-egg based influenza vaccine production, all companies are optimistic that their efforts will come to fruition. © 2011 Elsevier Ltd.

Lopert R.,Therapeutic Goods Administration | Gleeson D.,La Trobe University
Journal of Law, Medicine and Ethics | Year: 2013

The United States' pursuit of increasingly TRIPS-Plus levels of intellectual property protection for medicines in bilateral and regional trade agreements is well recognized. Less so, however, are U.S. efforts through these agreements to influence and constrain the pharmaceutical coverage programs of its trading partners. Although arguably unsuccessful in the Australia- U.S. Free Trade Agreement (AUSFTA), the U.S. nevertheless succeeded in its bilateral FTA with South Korea (KORUS) in establishing prescriptive provisions pertaining to the operation of coverage and reimbursement programs for medicines and medical devices, which have the potential to adversely impact future access in that country. More recently, draft texts leaked from the current Trans Pacific Partnership Agreement (TPPA) negotiations show that U.S. objectives include not only AUSFTA-Plus and KORUS-Plus IP provisions but also ambitious inroads into the domestic health programs of its TPPA partners. This highlights the apparent conflict between trade goals - pursued through multilateral legal instruments to promote economic "health"- and public health objectives, such as the development of treatments for neglected diseases, the pursuit of efficiency and equity in priority setting, and the procurement of medicines at prices that reflect their therapeutic value and facilitate affordable access. © 2013 American Society of Law, Medicine & Ethics, Inc.

Molzon J.A.,U.S. Food and Drug Administration | Giaquinto A.,PhRMA Inc | Lindstrom L.,European Commission | Tominaga T.,Pharmaceuticals and Medical Devices Agency | And 4 more authors.
Clinical Pharmacology and Therapeutics | Year: 2011

The International Conference on Harmonisation (ICH) is an unparalleled undertaking, which has brought together drug regulatory authorities and pharmaceutical trade associations from Europe, Japan, and the United States, to discuss the scientific and technical aspects of medical product registration. Launched in 1990, the value and benefits of ICH to regulators are being realized. ICH has harmonized submission requirements and created a harmonized submission format that is relieving both companies and regulatory authorities of the burdens of assembling and reviewing separate submissions for each region. As more countries embrace ICH guidelines, we anticipate additional benefits, including the promotion of good review practices and, ultimately, a common regulatory language that will facilitate further interactions among global drug regulatory authorities. © 2011 ASCPT.

Megerlin F.,University of Paris Descartes | Megerlin F.,University of California at Berkeley | Lopert R.,George Washington University | Lopert R.,Therapeutic Goods Administration | And 2 more authors.
Health Affairs | Year: 2013

Biologics are medicines derived from a biological source. Their high prices and rapid uptake have raised hopes that with the gradual expiration of patents on the first generations of biologics, the advent of lower-cost follow-on products known as biosimilars will help "bend the cost curve." Although biosimilars have been available since 2006 within the European Union and are expected to save $15-$44 billion by 2020, the Food and Drug Administration (FDA) has yet to finalize the necessary regulatory processes for their approval in the United States. The European experience suggests, however, that once these are in place, the US biosimilar market may well emerge as bimodal: Initially, modestly discounted biosimilars deemed noninterchangeable with the original products will compete to become the initial treatment of choice in new patients. Subsequently, a second market may be anticipated for those products able to meet the FDA's higher standard for "interchangeability." In that market, discounts may be more dramatic. © 2013 Project HOPE-The People-to-People Health Foundation, Inc.

Birts C.N.,University of Southampton | Bergman L.M.,Therapeutic Goods Administration | Blaydes J.P.,University of Southampton
Oncogene | Year: 2011

CtBPs form NADH-sensitive chromatin-modifying complexes, which link cellular metabolism to gene transcription. They also function in the cytoplasm to regulate Golgi fissioning; their inhibition can consequently cause a Golgi-dependent checkpoint in G 2. We have recently identified a novel role of CtBPs in the maintenance of mitotic fidelity; inhibition of CtBP synthesis resulting in reduced association of aurora B with mitotic chromatin and aberrant segregation of chromosomes. Here, we demonstrate that it is the interaction of CtBPs with transcriptional regulators and/or chromatin-modifying enzymes in the cell nucleus, rather than their role in Golgi fission, which is critical for the maintenance of mitotic fidelity. © 2011 Macmillan Publishers Limited All rights reserved.

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