Biopharmaceutical & Herbal Medicine Evaluation Department of the MFDS published a list of frequently asked questions and answers among the regulatory consultation on cell therapy and gene therapy products.

Key contents  

• Q&A on general issues
• Q&A on quality
• Q&A on non-clinical issues 
• List of relevant regulations and guidelines                        

Pursuant to the implementation of the Korea-U.S. Free Trade Agreement, pharmaceutical patent-approval linkage 

system was introduced on March 15, 2015. The Korean patent-approval linkage system is composed of patent 

registration of pharmaceuticals, notice of application for certification, prohibition of sales and generic exclusivity. The

report analyzes the direct and indirect effects of drug approval-patent linkage system on domestic pharmaceutical 

industry, health policy, and employment.

Key contents

• Impact assessment overview (quantitative, qualitative)
• Calculation result
• Quantitative assessment (direct and indirect impact)
• Qualitative assessment (Focus group interview results and survey results)
• Study on drug approval-patent linkage system (US, Canada, Japan, China)

Biopharmaceutical & Herbal Medicine Evaluation Department of the MFDS described considerations for changes to 

manufacturing process of biological products. The guideline presents specific classification of the requirements of the 

submitted data depending on the importance of the changes in accordance with the 'Regulation on Approval and 

Review of Biological Products' and provides anufacturers with additional information on how to assess the impact on 

quality, safety and efficacy of changes in manufacturing process.

Scope

• Recombinant DNA products, cell culture-derived products, vaccines, plasma derived products of which main component is a protein that can be fully characterized

Key contents

• Considerations
• Types of manufacturing process change
• Comparability evaluation (Considerations for evaluation, quality, non-clinical trial, clinical trial)
• Example of data requirements and manufacturing process description etc.

National Institute of Food and Drug Safety Evaluation announced that it established and published a guideline for 

evaluation of cell-scaffold complex products including 3D bio-printing products.

Key contents

• Classification criteria and definition of cell-scaffold complex products including 3D bio-printing products
  
• Data scope of quality and characteristic analysis and considerations
  
• Considerations for evaluating non-clinical safety and efficacy
  
• Considerations in clinical trial and etc.
  

In addition, it revised and published a guideline onnon-clinical evaluation of gene therapy products, which contains 

important considerations for developing gene therapy products using genetic engineering technology.

Key contents

• Data on toxicity in the development of gene therapy products
  
• Data on pharmacological actions in gene therapy products