Development and Control of Medicines and Medical Devices

This new title describes the tests and processes undertaken to bring new medicines and medical devices to the market, and the work of the government agencies which ensure products of the highest standard. The text covers the controls to prove quality, safety, and efficacy prior to marketing, and postmarketing pharmacovigilance requirements. The different European registration processes for both medicines and medical devices are explained. Important ethical issues in their development are also reviewed. The role of the UK and pan-European regulatory authorities for medicine and medicinal devices (the MHRA and the EMEA), and of the National Institute for Clinical Excellence (NICE), are explained. A review of the ICH process, and of the activities of the US FDA and the World Health Organization (WHO) in drug and device regulation illustrate how other countries control these products. Providing a comprehensive single-volume review, Development and Control of Medicines and Medicinal Devices is an invaluable reference for all students undertaking healthcare studies and for all pharmacists. It is also an essential source for all working in the pharmaceutical and medical devices industries

New medicines and medical devices undergo a vast array of tests during development to demonstrate their quality, safety and efficacy. Controls also apply to ensure their continued safe use once marketed. Numerous government statutory regulations cover these requirements. This new title describes these tests and the processes undertaken to bring such products to the market, and the work of the government agencies who ensure products of the highest standards. Topics include the European registration processes for medicines and medical devices, and the roles of the UK and pan-European regulatory authorities (MHRA and EMEA). Other issues covered are the work of NICE, the importance of the ICH process, and the activities of the US FDA and the WHO in drug and device regulation. Ethical issues in product development are also considered. Development and Control of Medicines and Medical Devices is an essential reference for those working in the pharmaceutical and medical device industries and in government agencies responsible for the control of medicines and medical devices. It is also an invaluable reference for all students undertaking healthcare studies and for all pharmacists. Robin J Harman is an independent pharmaceutical and regulatory consultant.