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.

Autorentext

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 Yorknow CRC Press of Taylor & Francis Publishing Groupthe 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).

Inhalt

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