Regulatory Updates
Proposed amendments to the Regulation on Safety of Pharmaceuticals, etc.
Distribution date: 06 December 2022 | Final date for Comment: 04 February 2023
This amendment clarifies specific dispositions criteria - such as the cancellation of GMP compliance determination in case of violation by medicinal product manufacturers - which is in relation to the amendments of the "Regulations on Drug Safety Notice No. 2022-436"(notified on September 30, 2022), of which the amendment was made to define the dispositions criteria for GMP compliance determination cancellation in accordance with Article 41 of the Administrative Procedures Act.
Products Covered: Pharmaceuticals
Regulation Type: Regular notification
Proposed partical amendments to the “Standard on Pharmaceutical Equivalence Test”
Distribution date: 02 December 2022 | Final date for Comment: 31 January 2023
The proposed amendment to the Standard on Pharmaceutical Equivalance Test is as follows:1) Add standards for designating Reference Listed Drugs in accordance with the expanded scope of drugs subject to pharmaceutical equivalence study; 2) Harmonize bioequivalence criteria for narrow therapeutic index drugs with international standards;3) Strengthen management of excipient changes by taking into consideration the formulations of products; and4) Recalibrate pharmaceutical equivalence study document requirements for cases when manufacturing procedures and sites are changed
Products Covered: Pharmaceuticals
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 02 December 2022 | Final date for Comment: 31 January 2023
Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Isopyrazam.
Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) Dairy produce and birds' eggs (HS codes: 04.01, 04.07 and 04.08) Animal originated products (HS code: 05.04) Edible vegetables and certain roots and tubers (HS codes: 07.02, 07.04, 07.05, 07.06, 07.07, 07.09 and 07.10) Edible fruit and nuts (HS codes: 08.03, 08.04, 08.06, 08.07, 08.08, 08.09, 08.10 and 08.11) Cereals (HS codes: 10.01, 10.02, 10.03, 10.04, 10.07 and 10.08) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.02 and 12.05) Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 02 December 2022
Proposed maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Flutriafol.
Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) Dairy produce and birds' eggs (HS codes: 04.01, 04.07 and 04.08) Animal originated products (HS code: 05.04) Edible vegetables and certain roots and tubers (HS codes: 07.02, 07.04, 07.05, 07.07, 07.09 and 07.10) Edible fruit and nuts (HS codes: 08.03, 08.06, 08.07, 08.08, 08.09, 08.10 and 08.11) Coffee (HS code: 09.01) Cereals (HS codes: 10.01, 10.03, 10.04, 10.05, 10.07 and 10.08) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01, 12.02, 12.05, 12.07, 12.10 and 12.12) Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 02 December 2022 | Final date for Comment: 31 January 2023
Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Fludioxonil.
Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) Fish and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08) Dairy produce and birds' eggs (HS codes: 04.01, 04.07 and 04.08) Animal originated products (HS code: 05.04) Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) Edible fruit and nuts, peel of citrus fruit (HS codes: 08.01, 08.02, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) Mate and spices (HS codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) Cereals (HS codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01, 12.04, 12.05, 12.06, 12.07 and 12.12) Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 02 December 2022 | Final date for Comment: 31 January 2023
Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Trinexapac-ethyl.
Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) Dairy produce and birds' eggs (HS codes: 04.01, 04.07 and 04.08) Animal originated products (HS code: 05.04) Cereals (HS codes: 10.01, 10.02, 10.03, 10.04, 10.06, 10.07 and 10.08) Products of the milling industry (HS code: 11.03) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.05 and 12.12) Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 02 December 2022 | Final date for Comment: 31 January 2023
Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Pyraziflumid.
Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) Dairy produce, birds' eggs and natural honey (HS codes: 04.01, 04.07, 04.08 and 04.09) Animal originated products (HS code: 05.04) Edible vegetables and certain roots and tubers (HS codes: 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.13) Edible fruit and nuts, peel of citrus fruit (HS codes: 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) Mate and spices (HS codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01 and 12.07) Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 02 December 2022
Proposed maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Zoxamide.
Products Covered: Natural honey (HS code: 04.09) Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.02, 07.03, 07.07, 07.09 and 07.10) Edible fruit and nuts (HS codes: 08.03, 08.06, 08.07 and 08.11)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 02 December 2022
Proposed maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Pyridalyl.
Products Covered: Fish and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08) Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) Edible fruit and nuts (HS codes: 08.07, 08.10 and 08.11) Mate and spices (HS code: 09.03 and 09.10) Cereals (HS codes: 10.05 and 10.08) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01 and 12.12)
Regulation Type: Regular notification
SI 562 part 3 - Safety of toys: Migration of certain chemical elements
Distribution date: 24 November 2022
Products Covered: Toys
Regulation Type: Addendum to Regular Notification
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