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Vol. 68 (January 15, 2018)
  • Data 2018-01-15 17:28:00
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1

Ministry of Food and Drug Safety Published "Casebook of Regulatory Consultation on Advanced Biological products"

 

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  

  For more information, please visit the website.
   
2

Impact Assessment Report on "Pharmaceutical Patent-Approval Linkage System"

 

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)
  For more information, please visit the website.
3

Ministry of Food and Drug Safety Published Guideline on
"Comparability Evaluation of Biological Products for Manufacturing Process Changes"

 

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.
  For more information, please visit the website.
4

Ministry of Food and Drug Safety Published
Guidelines on "Evaluation of Cell-Scaffold Complex such as 3D Bio-Printing Products"
and
Guideline on "Non-clinical Evaluation of Gene Therapeutics"

 

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

  For more information, please visit the website.

 

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