Regulatory challenges in vaccine development in Asia

Regulatory challenges in vaccine development in Asia are discussed annually at World Vaccine Congress Asia

At World Vaccine Congress Asia last June, we brought together experts from China, Taiwan and Japan to discuss regulating of vaccine development to meet Asia's vaccine needs. The consensus amongst all 3 speakers was that safety is the utmost important issue when it came to vaccines. This is clearly due to their nature and their target group which are made up of mainly women and children.

Often manufacturers face substantial resistant for releasing biological products, of which vaccines fall under, and that is why regulatory bodies have put in place many preventive and safety measures that are in place as seen below.

Investigational new drug Application:

  • Phase 1: safety and immunogenicity
  • Phase 2: safety, immunogenicity and dose ranging
  • Phase 3: efficacy safety and immunogenicity

Lot release system:

  • Extensive BLA licensing process
  • BLA supplements
  • Lot Release system
  • Review of data on lot release protocols
  • Selected lot number testing

Clearly, the main goal is to prevent substandard lots from reaching the public. On top of that, new vaccines are not approved when the cold chain integrity has been compromised and this issue is more relevant in Asia because of the warmer weather. However, according to the Guidance of cold chain monitoring for vaccine importation, manufacturers can request the extension of transportation spec based on the temperature. This is of course based on the Challenge Test whereby the temperature is only allowed to vary from 8 to 25 degrees and only within 48hrs.

During the session, Dr Hideki Hasegawa also addressed how intranasal vaccine could be a good alternative for current vaccines, such as subcutaneous vaccine, based on the research studies that have been previously conducted and there is much room to develop this form of vaccination.

In terms of opportunities and challenges, there seem to be a significant number of virus crisis and pandemics in East Asian countries such as malaria, hand foot mouth disease and dengue. Furthermore, it is also difficult to predict the virus strains that may cause the next pandemic. Hence there is substantial demand for vaccines in this region and this opens up the market for the vaccine industry.

Asian regulators and key Asian vaccine stakeholders gather annually at World Vaccine Congress Asia to the latest legislations regarding vaccine development and implementation. For more information on what would be discussed, please visit:

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