|
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 [ ], 3.2 [ ], 7.2 [ ],
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 Minimum Requirements for Biological
Products
Partial
amendment to the Public Notice on National Release Testing.; (1 page(s), in
English)
|
|
6.
|
Description
of content: The Minimum
Requirements for Biological Products will be amended as follows:
The standard
for "Respiratory Syncytial virus RNA Vaccine" that is to be newly
approved will be added. And regarding the article of "Neurovirulence
safety test" in the section of "Tests on virus seed" of the
monograph for "Freeze-dried Live Attenuated Varicella Vaccine", the
requirements will be added that the test may be omitted when the virus seed
is already confirmed that it has no neurovirulence.
The Public
Notice on National Release Testing will be amended as follows:
The fee,
quantity and Institution for National Release Testing for "Respiratory
Syncytial virus RNA Vaccine" that is to be newly approved will be added.
|
|
7.
|
Objective
and rationale, including the nature of urgent problems where applicable: To establish the standard for manufacturing process, properties,
quality, storage, and others of pharmaceuticals to which special attention
must be paid for the attainment of public health and sanitation (Biological
products). In addition, to stipulate the pharmaceuticals to which special
attention must be paid for the attainment of public health and sanitation as
subject to National Release Testing, as well as fee, criterion, and quantity
for the testing.
|
|
8.
|
Relevant
documents:
Act on
Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals
and Medical Devices.
https://www.japaneselawtranslation.go.jp/en/laws/view/3213
This
amendment will be published in "KAMPO"
(Official Gazette) when adopted.
|
|
9.
|
Proposed
date of adoption: May 2025
Proposed date of entry into force: May 2025
|
|
10.
|
Final
date for comments: 30 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
|