(Appendix)  
Outline of the draft Partial Amendment of the Regulation for Enforcement 
of the Act on Securing Quality, Efficacy and Safety of Products including 
Pharmaceuticals and Medical Devices, and the Public Notice on Designated 
Biological Products  
 
1-1. The Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety 
of Products including Pharmaceuticals and Medical Devices  
With regard to National Release Testing of biological  pharmaceuticals such as vaccines 
and blood products by national regulatory authority, an international standard for 
assessment process of Summary Lot Protocol (SLP) has been provided by World Health 
Organization (WHO).  
In Japan, the SLP dossiers to be su bmitted for application of National Release Testing 
are specified under Article 197, Paragraph 2 of the Regulation for Enforcement of the Act 
on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and 
Medical Devices (hereinafter re ferred to as the “Regulation for Enforcement”), for 
biological pharmaceuticals designated by the Minister of Health, Labour and Welfare.  
 
1-2. The Public Notice on Designated Biological Pharmaceuticals  
According to Article 197, Paragraph 2 of the Regulati on for Enforcement, designated 
biological pharmaceuticals are specified by the public notice of Ministry of Health, Labour 
and Welfare (hereinafter as to the “Public Notice on Designated Biological 
Pharmaceuticals”).  
Currently, the Public Notice on Design ated Biological Pharmaceuticals specifies vaccines 
(excluding immunologicals for therapeutic use) only.  
 
2. The summary of this amendment  
The Regulation for Enforcement and the Public Notice on Designated Biological 
Pharmaceuticals will be partially amended to reflect the WHO standard on SLP. This 
partial amendment will extend  the designated biological pharmaceuticals to any biological 
pharm aceuticals.  
 