G/TBT/N/JPN/696  
6 April 2021  
(21-2844) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  JAPAN   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Ministry of Health, Labour and Welfare  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
PHARMACEUTICAL PRODUCTS (HS 30)  
5. Title, number of pages and language(s) of the notified document:  1) Partial 
amendment to the Regulation for Enforcement of the Act on Securing Quality, Efficacy 
and Safety of Products including Pharmaceuticals and Medical Devices, and 2) Partial 
amend ment to the Public Notice on Designated Biological Products 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 (1 page(s), in 
Englis h) 
6. Description of content:  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 under Article 197, Paragraph 2 of the 
Regulation for Enfo rcement will be partially amended to reflect the World Health 
Organization (WHO) standard on Summary Lot Protocol (SLP).  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  With regard to National Release Testing of biolo gical pharmaceuticals such 
as vaccines and blood products by national regulatory authority, an international standard 
for assessment process of SLP has been provided by WHO. In Japan, the SLP dossiers to 
be submitted for application of National Release Tes ting are specified under Article 197, 
Paragraph 2 of the Regulation for Enforcement, for biological pharmaceuticals designated 
by the Minister of Health, Labour and Welfare. This partial amendment will extend the 
designated biological pharmaceuticals to an y biological pharmaceuticals.; Other  
8. Relevant documents:   
The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals 
and Medical Devices. This amendment will be published in " KAMPO " (Official Gazette) 
when adopted.  G/TBT/N/JPN/696  
 
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  9. Proposed date of adoption:  June 2021.  
Proposed date of entry into force:  July 2021.  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Japan Enquiry Point  
International Trade Division  
Economic Affairs Bureau  
Ministry of Foreign Affairs  
Fax: (+81 3) 5501 8343  
E-mail: enquiry@mofa.go.jp   
https://members.wto.org/crnattachments/2021/TBT/JPN/21_2467_00_e.pdf