European Medicines Agency (EMA) is a decentralised body of the European Union with headquarters in London.
'The EMA began its activities in 1995, when the European system for authorising medicinal products was introduced, providing for a centralised and a mutual recognition procedure. The EMA has a role in both, but is primarily involved in the centralised procedure. Where the centralised procedure is used, companies submit one single marketing authorisation application to the EMA. A single evaluation is carried out through the Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP). If the relevant Committee concludes that quality, safety and efficacy of the medicinal product is sufficiently proven, it adopts a positive opinion. This is sent to the Commission to be transformed into a single market authorisation valid for the whole of the European Union.'
'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 EMA coordinates the evaluation and supervision of medicinal products throughout the European Union. The Agency brings together the scientific resources of the 28 EU Member States in a network of over 40 national competent authorities. It cooperates closely with international partners, reinforcing the EU contribution to global harmonisation.'

Different stages of the drug development and approval process in the USA, lead from preclinical trials (testing in animals), first application in humans through limited and broad clinical tests, to postmarketing studies.

By Dale E. Wierenga, Ph.D. and C. Robert Eaton
Office of Research and Development
Pharmaceutical Manufacturers Association

'In reviewing this report, it is important to keep in mind the realities of the drug discovery and development process. The U.S. system of new drug approvals is perhaps the most rigorous in the world. On average, it costs a company $359 million to get one new medicine from the laboratory to the pharmacist's shelf, according to a February 1993 report by the Congressional Office of Technology Assessment.'

See also Phase 1 2 3 4 Drug Trials, Food and Drug Administration, and European Medicines Agency.

The owner of MRI equipment has to ensure that the equipment does fulfill the local requirements.
In some countries, the requirements are more stringent than in others; in other countries, they are nonexistent.
The user in general is unable to check power output, gradient strength, or even field strength. The manufacturer has to cover authorized hardware and software updates after the initial installation and has to give guarantee for the requirements. Specially designed computer programs usually supervise the power output of MRI devices and will not allow or will interrupt any imaging or spectroscopy procedure exceeding those limits considered safe.

See also European Medicines Agency, FDA information:
www.fda.gov/cdrh/safety/mrisafety.html

Short name: Ami 227, generic name: Ferumoxtran, (USPIO)
Ferumoxtran is a substance of the class of ultrasmall superparamagnetic iron oxide used as a lymph node specific contrast agent for MRI.
See also Combidex®, Sinerem® and Ultrasmall Superparamagnetic Iron Oxide.
Partner(s): Cytogen Corporation, National Cancer Institute. An approvable letter was received from the U.S. Food and Drug Administration for Combidex in June 2000. Advanced Magnetics, Inc. has submitted a complete response to the approvable letter received from the U.S. Food and Drug Administration, which was accepted by the FDA and assigned a user fee goal date of March 30, 2005. In Europe, a Dossier (the European equivalent of a NDA) was submitted by Advanced Magnetics' European partner, Guerbet SA, to the European Medicines Evaluations Agency in December 1999. (Sinerem® is the brand name for this USPIO in Europe manufactured by Guerbet, Combidex® by Advanced Magnetics for the U.S. market)
Advanced Magnetics, Inc. changed its name in July 2007 to AMAG Pharmaceuticals Inc.