|
Therapeutics Goods Administration
The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health and Aged Care, the TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics. Any items that claim to have a therapeutic effect, are involved in the administration of medication, or are otherwise covered by the ''Therapeutic Goods Act 1989'', the ''Therapeutic Goods Regulations 1990'', or a ministerial order, must be approved by the TGA and registered in the Australian Register of Therapeutic Goods. Structure of the TGA and medical regulation in Australia In Australia, medical products are regulated by the TGA and, for controlled drugs such as cannabis, the Office of Drug Control (ODC). Together, the TGA and ODC form the Health Products Regulation Group within the Department of Health and Aged Care. The Health Products Regulation Group ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Australian Government
The Australian Government, also known as the Commonwealth Government, is the national government of Australia, a federal parliamentary constitutional monarchy. Like other Westminster-style systems of government, the Australian Government is made up of three branches: the executive (the prime minister, the ministers, and government departments), the legislative (the Parliament of Australia), and the judicial. The legislative branch, the federal Parliament, is made up of two chambers: the House of Representatives (lower house) and Senate (upper house). The House of Representatives has 151 members, each representing an individual electoral district of about 165,000 people. The Senate has 76 members: twelve from each of the six states and two each from Australia's internal territories, the Australian Capital Territory and Northern Territory. The Australian monarch, currently King Charles III, is represented by the governor-general. The Australian Government in its executive ca ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Australian Technical Advisory Group On Immunisation
The Australian Technical Advisory Group on Immunisation (ATAGI) is a technical advisory group of the Australian Government. As part of the Department of Health, ATAGI provides advice to the Minister of Health on the immunisation program of Australia and related matters, including the strength of evidence pertaining to existing, new, and emerging vaccines. Roles ATAGI's role * The main role of ATAGI is to provide advice on the administration of vaccinations related to the National Immunisation Program (NIP) to the Minister of Health * Advisory on the ongoing immunisation research or the most needed areas * furnish industry supports with pre-accommodation guidance for likely entries to the Pharmaceutical Benefits Advisory Committee (PBAC) on immunisation viability and use in Australia. ATAGI guidance should be looked for before support making an accommodation to the PBAC * Discussion with pertinent associations to create the Australian Immunisation Handbook * Discussion with si ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation Of Medical Devices
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For example: * in biology, gene regulation and metabolic regulation allow living organisms to adapt to their environment and maintain homeostasis; * in government, typically regulation means stipulations of the delegated legislation which is drafted by subject-matter experts to enforce primary legislation; * in business, industry self-regulation occurs through self-regulatory organizations and trade associations which allow industries to set and enforce rules with less government involvement; and, * in psychology, self-regulation theory is the study of how individuals regulate their thoughts and behaviors to reach goals. Social Regulation in the social, political, psychological, and economic domains can take many forms: legal restrictions ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
National Agencies For Drug Regulation
National may refer to: Common uses * Nation or country ** Nationality – a ''national'' is a person who is subject to a nation, regardless of whether the person has full rights as a citizen Places in the United States * National, Maryland, census-designated place * National, Nevada, ghost town * National, Utah, ghost town * National, West Virginia, unincorporated community Commerce * National (brand), a brand name of electronic goods from Panasonic * National Benzole (or simply known as National), former petrol station chain in the UK, merged with BP * National Car Rental, an American rental car company * National Energy Systems, a former name of Eco Marine Power * National Entertainment Commission, a former name of the Media Rating Council * National Motor Vehicle Company, Indianapolis, Indiana, USA 1900-1924 * National Supermarkets, a defunct American grocery store chain * National String Instrument Corporation, a guitar company formed to manufacture the first resonator g ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical And Health Organisations Based In Australia
Medicine is the science and practice of caring for a patient, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care practices evolved to maintain and restore health by the prevention and treatment of illness. Contemporary medicine applies biomedical sciences, biomedical research, genetics, and medical technology to diagnose, treat, and prevent injury and disease, typically through pharmaceuticals or surgery, but also through therapies as diverse as psychotherapy, external splints and traction, medical devices, biologics, and ionizing radiation, amongst others. Medicine has been practiced since prehistoric times, and for most of this time it was an art (an area of skill and knowledge), frequently having connections to the religious and philosophical beliefs of local culture. For example, a medicine man would apply herbs and say prayers for healing, or an ancie ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Commonwealth Government Agencies Of Australia
A commonwealth is a traditional English term for a political community founded for the common good. Historically, it has been synonymous with "republic". The noun "commonwealth", meaning "public welfare, general good or advantage", dates from the 15th century. Originally a phrase (the common-wealth or the common wealth – echoed in the modern synonym "public wealth"), it comes from the old meaning of "wealth", which is "well-being", and is itself a loose translation of the Latin res publica (republic). The term literally meant "common well-being". In the 17th century, the definition of "commonwealth" expanded from its original sense of "public welfare" or "commonweal" to mean "a state in which the supreme power is vested in the people; a republic or democratic state". The term evolved to become a title to a number of political entities. Three countries – Australia, the Bahamas, and Dominica – have the official title "Commonwealth", as do four U.S. states and two U.S. territo ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Standard For The Uniform Scheduling Of Medicines And Poisons
The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is an Australian legislative instrument produced by the Therapeutic Goods Administration (TGA)., subsection 4A. Before 2010, it was known as the ''Standard for the Uniform Scheduling of Drugs and Poisons'' (''SUSDP'').. The SUSMP classifies drugs and poisons into different Schedules signifying the degree of control recommended to be exercised over their availability to the public.. , the most recent version is the ''Poisons Standard October 2022''. The Schedules are referred to under State and Territory legislation for regulatory purposes. Although each State and Territory has its own laws, the vast majority of medicines and poisons are classified according to the SUSMP to achieve uniform national regulation. Schedules Schedule 1 Schedule 1 is blank. Schedule 1 does not currently contain any medicines or poisons. Schedule 2: Pharmacy Medicine Schedule 2 (S2) drugs and poisons, otherwise known ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Council For Harmonisation Of Technical Requirements For Pharmaceuticals For Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration. Harmonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health. Junod notes in her 2005 treatise on Clinical Drug Trials that "Above all, the ICH has succeeded in aligning clinical trial requirements." History In the 1980s the European Union began harmonising regulatory requirem ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Johnson & Johnson COVID-19 Vaccine Developed By Janssen
Johnson is a surname of Anglo-Norman origin meaning "Son of John". It is the second most common in the United States and 154th most common in the world. As a common family name in Scotland, Johnson is occasionally a variation of ''Johnston'', a habitational name. Etymology The name itself is a patronym of the given name ''John'', literally meaning "son of John". The name ''John'' derives from Latin ''Johannes'', which is derived through Greek ''Iōannēs'' from Hebrew ''Yohanan'', meaning "Yahweh has favoured". Origin The name has been extremely popular in Europe since the Christian era as a result of it being given to St John the Baptist, St John the Evangelist and nearly one thousand other Christian saints. Other Germanic languages * Swedish: Johnsson, Jonsson * Icelandic: Jónsson See also * List of people with surname Johnson *Gjoni (Gjonaj) *Ioannou * Jensen *Johansson * Johns *Johnsson * Johnston *Johnstone *Jones *Jonson *Jonsson *Jovanović Jovanović ( sr-Cyrl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Janssen COVID-19 Vaccine
The Janssen COVID19 vaccine, sold under the brand name Jcovden, is a COVID19 vaccine that was developed by Janssen Vaccines in Leiden, Netherlands, and its Belgian parent company Janssen Pharmaceuticals, a subsidiary of American company Johnson & Johnson. It is a viral vector vaccine based on a human adenovirus that has been modified to contain the gene for making the spike protein of the SARS-CoV-2 virus that causes COVID19. The body's immune system responds to this spike protein to produce antibodies. The vaccine requires only one dose and does not need to be stored frozen. Clinical trials for the vaccine were started in June 2020, with phaseIII involving around 43,000 people. On 29 January 2021, Janssen announced that 28 days after a completed vaccination, the vaccine was 66% effective in a one-dose regimen in preventing symptomatic COVID19, with an 85% efficacy in preventing severe COVID19 and 100% efficacy in preventing hospitalization or death caused by the disease ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Moderna
Moderna, Inc. ( ) is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts that focuses on RNA therapeutics, primarily mRNA vaccines. These vaccines use a copy of a molecule called messenger RNA (mRNA) to produce an immune response. The company's only commercial product is the Moderna COVID-19 vaccine, marketed as Spikevax. As of 2022, the company has 44 treatment and vaccine candidates, of which 21 have entered clinical trials. Targets for vaccine candidates include influenza, HIV, respiratory syncytial virus, Epstein–Barr virus, the Nipah virus, chikungunya, a combined single-shot COVID-19 booster and influenza vaccine, a cytomegalovirus vaccine, and two cancer vaccines. The company's pipeline also includes candidates for cancer immunotherapy using OX40 ligand, interleukin 23, IL36G, and interleukin 12 as well as, in partnership with AstraZeneca, a regenerative medicine treatment that encodes vascular endothelial growth factor A to stimul ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pfizer
Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer (1824–1906) and his cousin Charles F. Erhart (1821–1891). Pfizer develops and produces medicines and vaccines for immunology, oncology, cardiology, endocrinology, and neurology. The company has several blockbuster drugs or products that each generate more than billion in annual revenues. In 2020, 52% of the company's revenues came from the United States, 6% came from each of China and Japan, and 36% came from other countries. Pfizer was a component of the Dow Jones Industrial Average stock market index from 2004 to August 2020. The company ranks 64th on the Fortune 500 and 49th on the Forbes Global 2000. History 1849–1950: Early history Pfizer was founded in 1849 by Charles Pfizer and Charles F. Erhart, two cousins who had i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
_I_(cropped).jpg "Click for more on -> Therapeutics Goods Administration")
