Newsletters

HOME > Newsletters
Vol. 67 (December 18, 2017)
  • Data 2017-12-18 15:17:01
  • View 512




Notice on the partial revision to
Regulation on the Designation, Approval Procedures, Method
of Biological Products Subject to National Lot Release(Draft)

Ministry of Food and Drug Safety will revise the part of the Regulation on the Designation, Approval Procedures and Method of Biological Products subject to National Lot Release as follows. Major changes occur in the application processing period, the sample amount and testing items for national lot release of biologics.

Major changes


- Extends in processing period of application for 4 biologics such as freeze-dried cell culture-derived Japanese Encephalitis Vaccine. (Appendix 1)
- Establishes newly approved products on the Appendix 1 table and removes withdrawal approved products from the list (Appendix 1)
- Changes in sample amount (Appendix 2) - Changes in testing items (Appendix 3).

For more information, please visit the website

Report on Developments and Regulatory Aspects of Innovative Monoclonal Antibodies

Over the past decade, Monoclonal Antibodies(mAb) has become an important biopharmaceutics in diseases such as cancer, autoimmune disease and so on. National Institute of Food and Drug Safety Evaluation(NIFDS) published the Report on ‘Developments and Regulatory Aspects of Innovative mAbs’ which covers market information, domestic and overseas R&D trends and related regulatory information in order to support the development of such products.

Major contents

- Global market information
- Development Trends (ADC*, ALP** etc.)
- Regulatory Trends


* ADC, Antibody-drug conjugate
**ALP, Antibody like protein

For more information, please visit the website

QnA Report on Drug Approval Patent Linkage System

The MFDS published the QnA Report on Drug Approval Patent Linkage System in order to help applications understanding the system.

For more information, please visit the website

List





Previous Vol. 66 (December 4, 2017)
Next Vol. 68 (January 15, 2018)