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Plates vi & vii of the Edwin Smith Papyrus (around the 17th century BC), among the earliest medical guidelines. A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare.
The authority will replace the Therapeutic Goods Administration in Australia [1] and Medsafe in New Zealand. [2] It has been proposed that the ANZTPA regulate: Complementary medicines; Over-the-counter medicines; Prescription medicines; Medical devices; Blood & blood products; Tissues; Cellular therapies.
Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, is the medical regulatory body run by the New Zealand Ministry of Health, administering the Medicines Act 1981 and Medicines Regulations 1984. [1] Medsafe employs approximately 60 staff members in two offices.
Medicines and Medical Devices Safety Authority (Medsafe) 2013 Norway: Norwegian Medicines Agency (NOMA) 1995 Poland: Chief Pharmaceutical Inspectorate (CPI) 2006 Portugal: National Authority of Medicines and Health Products, IP Autoridade Nacional do Medicamento e Produtos de Saúde IP (INFARMED IP ) 1999 Romania
The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. [4] As part of the Department of Health and Aged Care, the TGA regulates the safety, quality, efficacy and advertising in Australia of therapeutic goods (which comprise medicines, medical devices, biologicals and certain other therapeutic goods).
In 2012, at the margins of the 65th World Health Assembly conference in May the Minister of Health of Brazil proposed an agenda to create a new coalition of Heads of Agency "to address current and emerging human medicine regulatory and safety challenges globally, strategically and in an ongoing, transparent, authoritative and institutional manner."
The QPPV must reside in the EU, and should be permanently and continuously at the disposal of the MAH. Each company (i.e. Applicant/Marketing Authorisation Holder or group of Marketing Authorisation Holders using a common pharmacovigilance system) should appoint one QPPV responsible for overall pharmacovigilance for all medicinal products for which the company holds marketing authorisations ...
Pharmac was created in 1993 as a response to the ever-increasing costs of pharmaceuticals. The agency's primary aim is "to secure for eligible people in need of pharmaceuticals, the best health outcomes that are reasonably achievable from pharmaceutical treatment and from within the amount of funding provided."