Regulatory Updates

Distribution date: 09 September 2026 | Final date for Comment: 09 October 2026

The Minimum Requirements for Biological Products will be amended as follows: ・Regarding the standard for “Recombinant Adsorbed Hepatitis B Vaccine (Prepared from Yeast)”, “Tests on vector and inserted gene” will be amended to “Tests on inserted gene”.・Regarding the standard for “Freeze-dried Live Attenuated Rubella Vaccine”, a test by Reverse Transcription Polymerase Chain Reaction (RT-PCR) may be used for the Identification Test.・Regarding the standard for “Freeze-dried Live Attenuated Measles Vaccine”, a test by RT-PCR may be used for the Test for freedom from extraneous viruses and the Identification Test.・In addition, regarding the standard for “Freeze-dried Live Attenuated Measles-Rubella Combined Vaccine”, a test by RT-PCR may be used for the Confirmation of the labeling.

Products Covered: Pharmaceutical products (HS: 30)

Regulation Type: Regular notification

Distribution date: 08 September 2026 | Final date for Comment: 08 October 2026

The draft Resolution has been developed with the aim of regulating the procedures for the importation of medicinal products (excluding active pharmaceutical ingredients) into Ukraine, conducting state quality control of imported medicinal products in a state laboratory or a laboratory authorized by the Ukrainian Pharmaceutical Agency, and carrying out the official batch release of certain biological medicinal products (immunological medicinal products and medicinal products derived from human blood or blood plasma).The draft Resolution is aimed at implementing the Law of Ukraine No. 2469-IX of 28 July 2022 “On Medicines” and establishing a unified regulatory framework for the relevant procedures applicable to medicinal products imported into Ukraine.Specifically, the draft Resolution provides for:Approval of new procedures and criteria:Procedure for conducting state quality control of medicinal products in a state laboratory or a laboratory authorized by the Ukrainian Pharmaceutical Agency;Procedure for the official batch release of certain biological medicinal products (immunological medicinal products and medicinal products derived from human blood or blood plasma);Criteria for establishing an annual programme (plan) for the sampling of medicinal products and the grounds for conducting ad hoc laboratory quality control of medicinal products. Transitional and special provisions for importers:Establishing a one-year transitional period starting on 1 January 2027 during which importers whose information was not included in the registration dossier as of 1 January 2027 may perform quality control of imported medicinal products without amending the registration dossier, submitting a notification of changes to the licensing information, or obtaining a GMP certificate, under the specified conditions;Allowing, during the period of martial law and for six months after its termination or cancellation, the import of registered medicinal products in foreign packaging manufactured for the markets of other countries that do not comply with the approved registration dossier, for the purpose of supplying healthcare institutions with medicinal products procured through centralized public procurement, provided that the products are accompanied by a package leaflet (instructions for medical use) approved in Ukraine and a manufacturer's/marketing authorisation holder's guarantee letter confirming that the imported medicinal product is identical to the product registered in Ukraine;Establishing a procedure for reviewing applications submitted before 1 January 2027 for the issuance of conclusions on the quality of imported medicinal products and on the compliance of medicinal immunobiological products with the requirements of national and international standards, in accordance with the legislation in force prior to the entry into force of the Resolution.

Products Covered: Medicines

Regulation Type: Revision to Regular Notification

Distribution date: 08 September 2026 | Final date for Comment: 07 November 2026

This document specifies the classification criteria, the decision logic and guidance, and the labelling for oxidizing solids.This document applies to the classification and labelling of oxidizing solids in accordance with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS, 11th Revised Edition).

Products Covered: Chemicals (HS code(s): 2842; 293148; 293149; 293159; 293190; 2942); (ICS code(s): 13.300)

Regulation Type: Regular notification

Distribution date: 08 September 2026 | Final date for Comment: 07 November 2026

This document specifies the classification criteria, the decision logic and guidance, and the labelling of flammable liquids.This document applies to the classification and labelling of flammable liquids in accordance with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS, 11th Revised Edition).

Products Covered: Chemicals (HS code(s): 2709; 271012; 290211; 290230; 290250; 320810; 321410; 321511; 330112; 330113; 330210; 370710; 380510; 380891; 380892; 380893); (ICS code(s): 13.300)

Regulation Type: Regular notification

Distribution date: 08 September 2026 | Final date for Comment: 07 November 2026

This document specifies the basic principles, general requirements, rules for naming common names, and content for labeling of Chinese names for fertilizer.This document applies to the naming, use, and labeling management of Chinese names for all types of fertilizer products produced (including repackaging of imported products) and sold (including sales of imported products) within the territory of the People's Republic of China.This document does not apply to the naming, use, and labeling management of Chinese names for specialized fertilizer products that are customized by producers according to contracts for end-users, are not circulated in the market in any form, and are not publicly sold to society.

Products Covered: Fertilizers (HS code(s): 282710; 283421; 3101; 310520; 31055; 310560; 310590); (ICS code(s): 65.080)

Regulation Type: Regular notification

Distribution date: 08 September 2026 | Final date for Comment: 07 November 2026

This document specifies the product classification, limit requirements for  hazardous substances, inspection rules, and packaging and marking for adhesives, and describes the corresponding test methods.This document applies to solvent-based, water-based and solvent-free adhesives. This document does not apply to adhesives for national defence and military use, aerospace adhesives, medical adhesives, adhesives for food packaging, or adhesives based on urea-formaldehyde resin, phenolic resin and melamine-formaldehyde resin adhesives for the wood industry.

Products Covered: Vinyl acetate copolymers, in aqueous dispersion; encapsulation material of semiconductor devices; glues based on starches or dextrins; structural silicone sealant; other products suitable for use as glues or adhe-sives, put up for retail sale; adhesives based on polyamide; adhesives based on epoxy resin; other adhesives based on rubber or plastic; other prepared glues and adhesives, not elsewhere specified (HS code(s): 321410; 350520; 3506; 390521); (ICS code(s): 83.180)

Regulation Type: Regular notification

Distribution date: 07 September 2026 | Final date for Comment: 03 November 2026

Notice of availability and request for comment - The Environmental Protection Agency (EPA or Agency) is announcing the availability of and seeking public comment on a draft risk evaluation under the Toxic Substances Control Act (TSCA) for 1,2- dichloropropane. The purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment under the conditions of use (COUs), including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, and without consideration of costs or non-risk factors. EPA is seeking comment on the draft risk evaluation for 1,2-dichloropropane.

Products Covered: 1,2-Dichloropropane (CAS Number: 78-87-5); Saturated chlorinated derivatives of acyclic hydrocarbons (excl. chloromethane [methyl chloride], chloroethane [ethyl chloride], dichloromethane [methylene chloride], chloroform [trichloromethane], carbon tetrachloride and ethylene dichloride [ISO] [1,2 dichloroethane]) (HS code(s): 2903.19); Pollution, pollution control and conservation (ICS code(s): 13.020.40); Occupational safety. Industrial hygiene (ICS code(s): 13.100); Production in the chemical industry (ICS code(s): 71.020); Products of the chemical industry (ICS code(s): 71.100)

Regulation Type: Regular notification

Distribution date: 04 September 2026 | Final date for Comment: 03 November 2026

This Draft East African Standard specifies the requirements, sampling and test methods for fluoridated and non-fluoridated toothpaste.  This standard is not applicable to toothpaste for which therapeutic claims are made, tooth powder, toothpaste tablets, oral rinse, mouth wash and mouth rinse.

Products Covered: Dentifrices, incl. those used by dental practitioners (HS code(s): 330610); Cosmetics. Toiletries (ICS code(s): 71.100.70); Toothpaste

Regulation Type: Regular notification

Distribution date: 04 September 2026 | Final date for Comment: 03 November 2026

This Draft East African Standard specifies the requirements, sampling and test methods for fluoridated and non-fluoridated toothpaste.  This standard is not applicable to toothpaste for which therapeutic claims are made, tooth powder, toothpaste tablets, oral rinse, mouth wash and mouth rinse.

Products Covered: Dentifrices, incl. those used by dental practitioners (HS code(s): 330610); Cosmetics. Toiletries (ICS code(s): 71.100.70); Toothpaste

Regulation Type: Regular notification

Distribution date: 04 September 2026 | Final date for Comment: 03 November 2026

This Draft East African Standard specifies the requirements, sampling and test methods for fluoridated and non-fluoridated toothpaste.  This standard is not applicable to toothpaste for which therapeutic claims are made, tooth powder, toothpaste tablets, oral rinse, mouth wash and mouth rinse.

Products Covered: Dentifrices, incl. those used by dental practitioners (HS code(s): 330610); Cosmetics. Toiletries (ICS code(s): 71.100.70); Toothpaste

Regulation Type: Regular notification