  
  
G/TBT/N/JPN/687  
27 January 2021  
(21-0759) 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:  Partial 
amendment to the Ministerial Order for the Standard of Manufacturing Control and Quality 
Control for Drugs and Quasi -Drugs. (1 page(s), in English)  
6. Description of content:  The Ministerial Order for the Standard of Manufacturing Control 
and Quality Control for Drugs and Quasi -Drugs will be partially amended to reflect the 
Good Manufacturing Practice (GMP) Guide of the Pharmaceutical Inspection 
Convention/Pharmaceutic al Inspection Cooperation Scheme (PIC/S), which is amended 
in 2018.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The PIC/S GMP Guide is a leading international standard for pharmaceutical 
GMP. Japan's competent aut hority, Ministry of Health, labour and Welfare has participated 
to PIC/S since 2015; 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.  
9. Proposed date of adoption:  After March 2021.  
Proposed date of entry into force:  1 August 2021  
10. Final date for comments:  60 days from notification  G/TBT/N/JPN/687  
 
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  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_0677_00_e.pdf  
 