Enforcement decree of the Act on advanced regenerative medicine and advanced biological products regarding safety and support
Distribution date: 19 May 2020 | Final date for Comment: 18 July 2020
- As the “Act on Safety and Support of Advanced Regenerative Medicine and Advanced Biological Products” is established, “Enforcement Decree of the Act on Safety and Support of Advanced Regenerative Medicine and Advanced Biological Products” is enacted to prescribe the matters delegated by the Act and those necessary for its implementation. - Article 31: to prescribe facility standards required for the notification of importing business of advanced biological products. - Article 32: to prescribe facilities, equipment, human resources, and quality management system required for the approval of human cell management business, etc. - Article 34-36: 1) to stipulate that long-term follow-up investigations may be conducted on certain advanced biological products containing stem cell treatments, animal tissue and cells, gene therapy products and other advanced biological products that need to be monitored for adverse events over a specific period after administration. 2) to prescribe matters related to the designation as a subject of such investigations, the withdrawal of the designation, etc.
Products Covered: Biological Products
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 19 May 2020
The proposed maximum residue limits (MRLs) for Gentamicin notified in G/SPS/N/JPN/668 (dated 8 August 2019) were adopted and published on 15 January 2020. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 19 May 2020
The proposed maximum residue limits (MRLs) for Gentamicin notified in G/SPS/N/JPN/668 (dated 8 August 2019) were adopted and published on 15 January 2020. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 19 May 2020
The proposed maximum residue limits (MRLs) for Flubendiamide notified in G/SPS/N/JPN/695 (dated 21 November 2019) were adopted and published on 25 February 2020. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 19 May 2020
The proposed maximum residue limits (MRLs) for Flubendiamide notified in G/SPS/N/JPN/695 (dated 21 November 2019) were adopted and published on 25 February 2020. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 19 May 2020
The proposed maximum residue limits (MRLs) for Chloropicrin notified in G/SPS/N/JPN/700 (dated 6 December 2019) were adopted and published on 31 March 2020. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 19 May 2020
The proposed maximum residue limits (MRLs) for Chloropicrin notified in G/SPS/N/JPN/700 (dated 6 December 2019) were adopted and published on 31 March 2020. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 19 May 2020
The proposed maximum residue limits (MRLs) for Cyenopyrafen notified in G/SPS/N/JPN/672 (dated 8 August 2019) were adopted and published on 15 January 2020. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 19 May 2020
The proposed maximum residue limits (MRLs) for Cyenopyrafen notified in G/SPS/N/JPN/672 (dated 8 August 2019) were adopted and published on 15 January 2020. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 19 May 2020
The proposed maximum residue limits (MRLs) for Salinomycin notified in G/SPS/N/JPN/697 (dated 21 November 2019) were adopted and published on 25 February 2020. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
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