Global Regulations of Medicinal, Pharmaceutical, and Food Products

Medicine regulation demands the application of sound medical, scientific, and technical knowledge and skills, and operates within a legal framework. Regulatory functions involve interactions with various stakeholders (e.g., manufacturers, traders, consumers, health professionals, researchers, and governments) whose economic, social, and political motives may differ, making implementation of regulation both politically and technically challenging. This book discusses regulatory landscape globally and the current global regulatory scenario of medicinal products and food products comprehensively.

Features:

• Discusses how recent developments of medicinal and food products have opened up innovative solutions for many of the current challenges societies face presently.
• Explores the manifold variations between the regulatory bodies in different countries that have not previously been collected to this extent.
• Presents details on the substantial progress in analytical methodologies for labelling applications and the creation of appropriate test criteria for pharmaceuticals and their safety analysis.
• Reviews how more worldwide collaboration and cooperation in the regulatory area is still required.

Faraat Ali presently working as a Manager, Department of Inspection and Enforcement, Pharmaceutical Development Laboratory Services (Formerly National Drug Quality Control Laboratory), Botswana Medicines Regulatory Authority (BoMRA), Gaborone, Botswana. Mr Ali is a Graduate Pharmaceutical Scientist and completed Master of Pharmacy in Pharmaceutical and Medicinal Chemistry from Uttar Pradesh Technical University, India, Post Graduate Diploma in Drug Regulatory Affairs (PGDDRA) from Jamia Hamdard, India and Post Graduate Diploma in Management (PGDM) from WITS Business School, University of Witwatersrand, South Africa.

Leo M. L. Nollet earned an MS (1973) and PhD (1978) in biology from the Katholieke Universiteit Leuven, Belgium. He is an editor and associate editor of numerous books. He edited for M. Dekker, New York--now CRC Press of Taylor & Francis Publishing Group--the first, second, and third editions of Food Analysis by HPLC and Handbook of Food Analysis. The last edition is a two-volume book. Dr. Nollet also edited the Handbook of Water Analysis (first, second, and third editions) and Chromatographic Analysis of the Environment, third and fourth editions (CRC Press).