JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objective

This course is designed to impart fundamental knowledge on Regulatory

Requirements, Licensing and Registration, Regulation on Labelling of Biologics in India, USA and Europe It prepares the students to learn in detail on Regulatory Requirements for biologics, Vaccines and Blood Products

Course Outcome

Upon the completion of the course the student shall be able to :

• Know the regulatory Requirements for Biologics and Vaccines
• Understand the regulation for newly developed biologics and biosimilars
• Know the pre-clinical and clinical development considerations of biologics
• Understand the Regulatory Requirements of Blood and/or Its Components Including BloodProducts and label requirements

UNIT - I

India: Introduction, Applicable Regulations and Guidelines, Principles for Development of Similar Biologics, Data Requirements for Preclinical Studies, Data Requirements for Clinical Trial Application, Data Requirements for Market Authorization Application, Post-Market Data for Similar Biologics, Pharmacovigilance. GMP and GDP.

UNIT - II

USA: Introduction to Biologics; biologics, biological and biosimilars, different biological products, difference between generic drug and biosimilars, laws, regulations and guidance on biologics/ biosimilars, development and approval of biologics and biosimilars (IND, PMA, BLA, NDA, 510(k), pre-clinical and clinical development considerations, advertising, labelling and packing of biologics.

UNIT - III

European Union: Introduction to Biologics; directives, scientific guidelines and guidance related to biologics in EU, comparability/ bio similarity assessment, Plasma master file, TSE/ BSE evaluation, development and regulatory approval of biologics (Investigational medicinal products and biosimilars), pre-clinical and clinical development considerations; stability, safety, advertising, labelling and packing of biologics in EU.

UNIT - IV

Vaccine regulations in India, US and European Union: Clinical evaluation, Marketing authorization, Registration or licensing, Quality assessment, Pharmacovigilance, Additional requirements Blood and Blood Products Regulations in India, US and European Union: Regulatory Requirements of Blood and/or Its Components Including Blood Products, Label Requirements, ISBT (International Society of Blood Transfusion) and IHN (International Haemovigilence Network)

UNIT - V

Herbal Products: Quality, safety and legislation for herbal products in India, USA and European Union.

TEXT AND REFERENCE BOOKS:

• 1. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Douglas J. Pisano, David S. Mantus; Informa, 2008
• 2. Biological Drug Products: Development and Strategies; Wei Wang, Manmohan Singh; wiley, 2013
• 3. Development of Vaccines: From Discovery to Clinical Testing; Manmohan Singh, Indresh K. Srivastava; Wiley, 2011
• 4. www.who.int/biologicals/en
• 5. www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/
• 6. www.ihn-org.com
• 7. www.isbtweb.org
• 8. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India
• 9. www.cdsco.nic.in
• 10. www.ema.europa.eu › scientific guidelines › Biologicals
• 11. www.fda.gov/biologicsbloodVaccines/GuidanceCompliance Regulatory Information (Biologics) M.Pharm I Year II Sem (Pharmaceutical Regulatory Affairs)