Regulatory Updates

Distribution date: 22 October 2020 | Final date for Comment: 21 December 2020

Ministry of Health and Labour and Welfare will abolish the Japanese Pharmacopoeia Seventeenth edition and establish Eighteenth edition under Paragraph 1 of Article 41 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, the Japanese Pharmacopoeia, Seventeenth edition are to be revised.

Products Covered: Pharmaceutical Products (HS:30)

Regulation Type: Regular notification

Distribution date: 22 October 2020 | Final date for Comment: 21 December 2020

Ministry of Health and Labour and Welfare will abolish the Japanese Pharmacopoeia Seventeenth edition and establish Eighteenth edition under Paragraph 1 of Article 41 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, the Japanese Pharmacopoeia, Seventeenth edition are to be revised.

Products Covered: Pharmaceutical Products (HS:30)

Regulation Type: Regular notification

Distribution date: 20 October 2020

The Annex I of the Resolution – RDC number 405, 22 July 2020 – previously notified through G/TBT/N/BRA/1061 – which establishes control measures for medicines that contain substances mentioned by the Annex I of this resolution, isolated or in association with other drugs, due to the international public health emergency of the new coronavirus (SARS-CoV-2), was changed by the Resolution – RDC number 420, 1 September 2020. 

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 20 October 2020

The Annex I of the Resolution – RDC number 405, 22 July 2020 – previously notified through G/TBT/N/BRA/1061 – which establishes control measures for medicines that contain substances mentioned by the Annex I of this resolution, isolated or in association with other drugs, due to the international public health emergency of the new coronavirus (SARS-CoV-2), was changed by the Resolution – RDC number 420, 1 September 2020. 

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 20 October 2020 | Final date for Comment: 19 November 2020

(1) The Minimum Requirements for Biological Products shall be partially amended to add the standard for a blood product to be newly approved. (2) The Public Notice on National Release Testing shall be partially amended to provide for the above-mentioned blood product.

Products Covered: Pharmaceutical Products (HS: 30)

Regulation Type: Regular notification

Distribution date: 20 October 2020 | Final date for Comment: 19 November 2020

(1) The Minimum Requirements for Biological Products shall be partially amended to add the standard for a blood product to be newly approved. (2) The Public Notice on National Release Testing shall be partially amended to provide for the above-mentioned blood product.

Products Covered: Pharmaceutical Products (HS: 30)

Regulation Type: Regular notification

Distribution date: 20 October 2020 | Final date for Comment: 19 December 2020

The Ministry of Food and Drug Safety of the Republic of Korea is partly revising the “Pharmaceutical Affairs Act”. The main contents are: For the pharmaceutical imported, similar to pharmaceutical manufactured, the distribution has been managed thoroughly by prescribing the prohibition another pharmaceutical that is not identical with the approved and reported information such as ingredient and amount from importing, storing and displaying for the purpose of marketing. Under “Safety Control Act of Household Chemicals and Biocidal Product” (Established on 20 Mar 2018; Implemented on 1 Jan 2019), the managing body shall be excluded in the scope of quasi-drug as nematicide and humidifier disinfectant of fly and mosquito that were controlled as quasi-drug according to “Pharmaceutical Affairs Act” was changed. (Article 2, 62 and 68-4)

Products Covered: Pharmaceuticals, Quasi-drug

Regulation Type: Regular notification

Distribution date: 20 October 2020 | Final date for Comment: 19 December 2020

The Ministry of Food and Drug Safety of the Republic of Korea is partly revising the “Pharmaceutical Affairs Act”. The main contents are: For the pharmaceutical imported, similar to pharmaceutical manufactured, the distribution has been managed thoroughly by prescribing the prohibition another pharmaceutical that is not identical with the approved and reported information such as ingredient and amount from importing, storing and displaying for the purpose of marketing. Under “Safety Control Act of Household Chemicals and Biocidal Product” (Established on 20 Mar 2018; Implemented on 1 Jan 2019), the managing body shall be excluded in the scope of quasi-drug as nematicide and humidifier disinfectant of fly and mosquito that were controlled as quasi-drug according to “Pharmaceutical Affairs Act” was changed. (Article 2, 62 and 68-4)

Products Covered: Pharmaceuticals, Quasi-drug

Regulation Type: Regular notification

Distribution date: 19 October 2020

This Normative Instruction establishes the inclusion of a declaration in the label of pesticides informing the existence of a new formula changing its composition. This regulation will be also notified to the SPS committee.

Products Covered: HS Code(s): 38089910 (pesticides)

Regulation Type: Regular notification

Distribution date: 19 October 2020

This Normative Instruction establishes the inclusion of a declaration in the label of pesticides informing the existence of a new formula changing its composition. This regulation will be also notified to the SPS committee.

Products Covered: HS Code(s): 38089910 (pesticides)

Regulation Type: Regular notification