Global Regulations of Medicinal, Pharmaceutical, and Food Products -

Global Regulations of Medicinal, Pharmaceutical, and Food Products

Faraat Ali, Leo M.L. Nollet (Herausgeber)

Buch | Hardcover
332 Seiten
2024
CRC Press (Verlag)
978-1-032-28362-3 (ISBN)
129,95 inkl. MwSt
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).

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 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

Erscheinungsdatum
Zusatzinfo 24 Tables, black and white; 38 Line drawings, black and white; 38 Illustrations, black and white
Verlagsort London
Sprache englisch
Maße 156 x 234 mm
Gewicht 820 g
Themenwelt Naturwissenschaften Biologie
Naturwissenschaften Chemie
Technik
ISBN-10 1-032-28362-9 / 1032283629
ISBN-13 978-1-032-28362-3 / 9781032283623
Zustand Neuware
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