A Comparative Study of Biological Products Regulations in USA, CANADA, AUSTRALIA, EUROPE, SINGAPORE and INDIA

Kullanivagaira Kumari¹, K. Sunil Kumar*^2
1Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.
²Associate Professor, Department of Pharmaceutics – Drug regulatory affairs, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India

A  B S T R A C T
The FDA is an agency in the US Department of Health and Human Services charged with assuring the safety, efficacy, and security of human as well as veterinary drugs in addition to other areas of regulatory authority. The agency is also responsible for facilitating advances in medications. The study aims to evaluate the biological products regulations in USA, Canada, Australia, Europe, Singapore and India. Biopharmaceutical companies and their development partners increasingly use data from real‐world settings to generate evidence that can support regulatory decision making and approvals of their manufactured medical products. The intent is to provide the FDA information to allow a review that assures the safety of participants. For sponsor-investigators, typically, the IND will not require the same extensive information including preclinical studies or manufacturing and process information as would be required for a commercial sponsor applying for an IND for a yet unapproved drug, especially early in its development. For the approval of follow-on biologics in the United States, current regulations depends on whether the biologic product is approved under the United States Food, Drug, and Cosmetic Act or it is licensed under the United States Public Health Service Act. For those biologic drugs marketed under the PHS Act, the BPCI Act passed by the US Congress on March 23, 2010 amends the PHS Act to establish an abbreviated approval pathway for biological products that are highly similar or interchangeable with an FDA-authorized biologic drug, and gives the FDA the authority to approve follow-on biologics under new section 351(k) of the PHS Act. A comparison of the marketing authorization requirements for regulated and emerging countries has been described that all countries follow ICH regulation. The prime objective of the rules governing medicative products in the United States, Europe, Canada, Australia, and Singapore is to protect public health.
Keywords: Biological products, safety, efficacy, and security of human, regulatory authority.