Overview of the NDA/BLA Process in South Korea
What is it all about?
Pharmaceutical businesses looking for new business prospects find South Korea to be an attractive market with a fast-increasing pharmaceutical industry. With over nine-hundred (900) new drugs in the pipeline and exports totaling USD 3.1 billion, South Korea offers enormous potential for large-scale pharmaceutical manufacturing.
The NDA/BLA processes in South Korea offer various advantages for pharmaceutical businesses, including a quicker approval process, clear regulations and requirements, incorporation of RWE, and exemptions for orphan drugs. However, the NDA/BLA process in South Korea can be complex and time-consuming.
To give you a better perspective on the NDA/BLA process in South Korea, Freyr brings you a comprehensive webinar on:
The webinar will be hosted by Michael Lambell and presented by In Pyo Hong. During the webinar, our experts will discuss the following:
- Introduction
- Types of Business Licenses for Drug Products in Korea
- Dossier Preparation
- MFDS Review Process
- Health Authority Meeting
- GMP Site Inspection
- Approval
- DMF Registration
- Orphan Drug Designation
- Question & Answers
Given the keynotes and with due respect to your busy schedule, we look forward to seeing you in the webinar.
For more information on compliance best practices, write to us at contactus@freyrsolutions.com.
Michael has forty (40) years of industry experience, with twenty-nine (29) years in CMC Regulatory functions and an additional eleven (11) years in other scientific development roles. His experience includes collaborating with Regulatory partner companies.
In Pyo Hong is a Regulatory Expert with over twenty-five (25) years of experience in the Korean pharmaceutical industry. He specializes in Regulatory affairs for pharmaceutical and healthcare products.
Host
Michael Lambell
Sr. Vice President, MPR Regulatory Affairs
Presenter
In Pyo Hong
Associate Director, MPR Regulatory Affairs – South Korea