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If you have experienced any adverse side effects from a medication or therapy -
Drug Regulatory Agencies
Australia -
The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances. tga.gov/au
Canada -
Federal department responsible for helping Canadians maintain and improve their health, while respecting individual choices and circumstances.
Special Access Programme (SAP)
EU -
The European Medicines Agency (E.M.E.A.) is a decentralised body of the European Union with headquarters in London.
Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.
The EMEA is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (centralised procedure). Under the centralised procedure, companies submit one single marketing authorisation application to the EMEA.
Tel -
India -
The New Zealand Medicines and Medical Devices Safety Authority. It is a business
unit of the Ministry of Health and is the authority responsible for the regulation
of therapeutic products in New Zealand -
Norway -
The agency is responsible for supervising the production, trials and marketing of
medicines. It approves medicines and monitors their use, and ensures cost-
Scotland -
The Scottish Medicines Consortium (S.M.C) provides advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) across Scotland about the status of all newly licensed medicines, all new formulations of existing medicines and new indications for established products (licensed from January 2002).
This advice will be made available as soon as practical after the launch of the product involved.
The remit of SMC excludes the assessment of vaccines, branded generics, non-
The review of device-
UK -
Drugs and devices are licensed and monitored for safety for use in the UK by the MHRA.
Medical devices are approved by private sector organisations called 'Notified bodies'.
The MHRA audits the performance of Notified Bodies -
UK -
NICE is an independent body responsible for providing national guidance on the promotion of good health and the prevention and treatment of illness within England and Wales, however, they have to receive sanction from the Department of Health before they consider a technology.
NICE determines the availability of new medicines for NHS patients within England and Wales.
NICE doesn’t always provide guidance as soon as a medicines are licensed for use.
NICE assess’s the clinical and cost effectiveness of specific drugs referred to the Institute by the Department of Health and the Welsh Assembly, they have to go through a process of selecting which drugs to look at. This would mean that before a drug becomes available for use on the NHS NICE would have to go through the approval process first prior to their system of approval begins..
NICE is not responsible for licensing drugs or devices in the UK or for monitoring their safety – that is the role of the Medicines and Healthcare products Regulatory Agency
NICE is asked to look at particular drugs and devices where there is confusion or uncertainty over the value of a drug or device, to end any uncertainty, NICE makes a national, (England & Wales), decision over its use.
Most licensed drugs and devices are assessed at a local level within the NHS through local prescribing arrangements to determine whether local hospitals and primary care organisations may use them.
The process of formulating and prioritising guidance is assisted by impartial clinicians, independent groups with no vested interest!
Note. N.I.C.E is an advisory body not a regulatory agency -
US A -
The FDA does NOT test drugs; for the most part, it's role is to provide safety guidelines for testing new drugs and then to review the data resulting from such testing in order to determine if the drug/biologic meets the FDA's "risk vs. benefit" criteria.
Investigational New Drug Programme (IND) Jan 2007