1st Edition
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.
Section 1 Global Regulatory Perspectives of Medicinal and Pharmaceuticals Products
Chapter 1: Introduction, Challenges and Overview of Regulatory Affairs
Faraat Ali, Kumari Neha, Anam Ilyas, and Hasan Ali
Chapter 2: Safety Perspectives of Medicinal Products
Rishi Kumar, Nishith Keserwani, and Parveen Kumar Goyal
Chapter 3: Regulations in the United States
Kumari Neha, Faraat Ali, Rutendo J. Kuwana, and Sharad K. Wakode
Chapter 4: Regulations in the European Union
Anam Ilyas, Faraat Ali, Vishesh Sahu, and Doaa Rady
Chapter 5: Regulations in the United Kingdom
Kumari Neha, Vivekanandan Kalaiselvan, and Faraat Ali
Chapter 6: Regulations in Canada
Hasan Ali, Sandeep Kumar Singh, Babar Iqbal, Neeraj Kant Sharma, Faraat Ali, and Md. Akbar
Chapter 7: Regulations in Australia and New Zealand
Kumari Neha, Faraat Ali, Gaurav Pratap Singh Jadaun, and Yayra Timothy Tuani
Chapter 8: Regulations in China
Varisha Anjum, Khushboo Sharma, Pritya Jha, Irina Potoroko, and Rishi Kumar
Chapter 9: Regulations in India
Arvind Kumar Sharma, Tarani Prakash Shrivastava, Meghna Amrita Singh, Jitin Ahuja, and Ramesh K. Goyal
Chapter 10: Regulations in Japan
Faraat Ali, Anam Ilyas, and Shaima Ahmadeen
Chapter 11: Regulations in the African Union/Southern African Region (SADC Region/ West African Region)
Faraat Ali, Evans Sagwa, and Colin Shamhuyarira
Chapter 12: Regulations in Latin American Countries
Tausif Alam and Irfan Ansari
Chapter 13: Regulations in ASEAN Countries
Manisha Trivedi, Faraat Ali, Kumari Neha, Neelam Singh, and Anam Ilyas
Chapter 14: Regulations in Gulf Cooperation Council (GCC) Countries
Usama Ahmad, Anas Islam, and Vazahat Ali
Section 2 Global Regulatory Perspectives of Food Products
Chapter 15: Introduction, Challenges, and Safety Issues of Food Regulation
Leo M.L. Nollet
Chapter 16: Food Products Regulations in the European Union
Varisha Anjum, Vishal Dixit, Pritya Jha, and Irina Potoroko
Chapter 17: Food Products Regulations in Canada
Faraat Ali, Hasan Ali, and Leo M.L. Nollet
Chapter 18: Food Products Regulations in the United Kingdom
Leo M.L. Nollet
Chapter 19: Food Products Regulations in the United States
Leo M.L. Nollet and Faraat Ali
Biography
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).
