Description
The US Pharmaceutical Regulatory Affairs Program describes the essential requirements for obtaining approval to market a new drug in the USA, the ‘NDA Process’.
The program describes preparing submissions using the Common Technical Document (CTD) Form and requirements for obtaining approval of human medicinal products in the US.
This course addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biological medicinal products, such as those based on mAbs, differ in certain respects from those for small-molecule products. This is because of the distinct characteristics of biologics, such as complex structure and susceptibility to variation during manufacture.
In this program, we focus on distinctive issues in the production and testing of mAbs, in the context of relevant regulatory guidance. We discuss manufacturing quality, nonclinical, and clinical issues. We address aspects specific to radiolabeled mAbs. Finally, we identify the pathways for applications to conduct clinical trials and to market mAb-based products in Europe and the USA.
Procedures for making regulatory submissions for monoclonal antibodies are discussed, such as the marketing authorization application through the CP (Centralized Procedure) in Europe, and by a BLA (Biologics License Application) in the USA. Orphan drug status and its effect on clinical design are also covered. The course addresses the impact of recent developments in production techniques on the regulatory landscape, and will serve as a good source of reference all developments in the future and their practical consequences.
The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than producing generic drugs. The US legal framework for the licensure of follow-on biologics, and accompanying regulatory guidance from the Food and Drug Administration (FDA), have been established only in recent years. This program will describe the provisions of the Biologics Price Competition and Innovation Act, identify criteria for licensing a follow-on biologic as ‘biosimilar’ or ‘interchangeable’, specify periods of market exclusivity that apply, and discuss patent infringement issues.
Finally, we describe the provisions of the Biosimilar User Fee Act, which authorizes the FDA to collect fees from follow-on biologics sponsors, to support review activities.
Courses included in this program are: 1) Essentials for Human Medicinal Products; 2) Orphan Drug Application; 3) How to Gain Approval to Market Generic Drugs in the US; 4) Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US; 5) Preparing Submissions in the Common Technical Document (CTD) Format; 6) Electronic Common Technical Document (eCTD); 7) The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA; and 8) Registration of Drugs Based on Monoclonal Antibodies.
