Regulatory Compliance for Biotherapeutics


This module provides an in-depth knowledge of the structure and key functions of the main regulatory bodies including the Food & Drug Administration (FDA) in the United States, the European Medicines Agency (EMA), the European Directorate for the Quality of Medicines (EDQM) in the European Union (EU) and National Regulatory bodies (i.e. Health Products Regulatory Authority).  It also addresses the global harmonisation initiatives and achievements of the International Council for Harmonisation (ICH) and evaluates its role in the regulation of medicinal products. 

It examines the current legislation relevant to the development and manufacturing of biotherapeutics.  This includes the Federal Food Drug & Cosmetic Act (1938), the Public Health Service Act (1944), and relevant amendments, relevant European Regulations and Directives, and regulatory guidelines.  It overviews the Code of Federal Regulations (CFR) and EUDRALEX, the rules and regulations governing medicinal products in the European Union, and evaluates the significance of these volumes in complying with regulatory requirements for the manufacture and marketing of biopharmaceutical products.  The various stages in the development of biopharmaceutics are reviewed from a regulatory perspective along with the different types of marketing authorisation applications that may be used, and regulatory inspections carried out at different stages throughout the life-cycle of the product are described.  

The module also looks at the challenges involved in regulating biopharmaceuticals compared with chemical drugs.  It examines the Critical Quality Attributes (CQA) of biotherapeutics and the Quality by Design (QbD) approach to manufacturing to ensure the safety, quality, and efficacy of these products.

Learning Outcomes

  1. Examine the roles of the FDA, EMA, EDQM, & ICH, respectively, in regulating the development and manufacturing of therapeutic antibodies and cell therapies. 

  2. Evaluate the key legislation governing the regulation of biotherapeutics in the US and the EU and the role of harmonisation initiatives in streamlining global regulatory compliance

  3. Apply current GLP, GCP and GMP principles to the development and manufacture of high quality, safe and efficacious therapies, assess critical quality attributes (CQA), and examine the Quality by Design (QbD) approach to biopharmaceutical manufacturing.

  4. Assess the key stages and processes involved in regulatory inspections (FDA and European) carried out during the development and production of biopharmaceutical facilities and evaluate different types of inspections.

  5. Appraise the key challenges in regulating the development and manufacture of therapeutic proteins and cell therapies compared with chemical drugs

  6. Apply knowledge of the United States, European, and National regulatory requirements in the development and manufacturing of biotherapeutics to the analysis presentation of case studies in various forms including posters, presentations, and written reports

% Coursework 50%
% Final Exam 50%