Regulatory Updates

Distribution date: 02 March 2022 | Final date for Comment: 01 May 2022

Australia's Therapeutic Goods Administration (TGA) is seeking feedback on a proposed priority pathway for assessment of certain novel and life-saving biologicals.  The proposed 'Priority Review' pathway will align with the pathway already in place for medicines and offer a faster formal assessment pathway for biologicals in certain circumstances. This will allow consumers with life-threatening diseases or seriously debilitating conditions to access these treatments in less time if the assessment results in a decision by the TGA to include the biological in the Australian Register of Therapeutic Goods (ARTG). Australia does not currently have a formal mechanism to expedite the assessment and inclusion of biologicals in the ARTG. Depending on the feedback received, the TGA could propose to the Australian Government that a priority pathway be implemented for the pre-market assessment and registration of novel biologicals that address unmet clinical needs for Australian consumers. This would require changes to the Therapeutic Goods Regulations 1990. The TGA is conducting a public consultation on the proposed pathway between February 2022 and March 2022 to seek feedback on: whether stakeholders support introduction of such a pathway eligibility criteria for the Priority Review pathway for biologicals the Process for determining whether a biological application meets the eligibility criteria for Priority Review (the ‘Determination Process’).

Products Covered: Products regulated by the Therapeutic Goods Administration (TGA) as ‘biologicals’ including human tissue-based products (e.g., skin, bone, ocular, cardiovascular donor tissue); cell-based products (e.g., genetically modified cells); immunotherapy products containing genetically engineered human cells (e.g., CAR-T cells); products that comprise or contain live animal cells, tissues or organs (e.g., pancreatic islet cells isolated from pigs); autologous human cell and tissue (HCT) products (e.g., human stem cell transplants); and faecal microbiota transplant (FMT) products.

Regulation Type: Regular notification

Distribution date: 02 March 2022 | Final date for Comment: 01 April 2022

(1) The Minimum Requirements for Biological Products will be partially amended to add the standard for a vaccine product to be newly approved.  (2) The fee, criterion and test sample quantity for National Release Testing will be partially amended to provide for the above-mentioned vaccine product.

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 01 March 2022 | Final date for Comment: 30 April 2022

With a view to enhancing the quality of cements, the Bureau of Standards, Metrology and Inspection (BSMI) is proposing to update the inspection standard CNS 61 for Portland Cement to its current version, published in 2021. The changes mainly involve maximum limits of added ingredients, maximum value of loss on ignition and insoluble residues in chemical substances, test of physical properties in fitness, specific surface, packaging and labeling. The conformity assessment procedures remains the same, i.e. Monitoring Inspection (MI) or Monitoring Inspection of Products from Premises with Registered Management System (MS-Based Monitoring Inspection). The obligatory inspection applicants will be allowed to print the Commodity Inspection Mark by themselves, instead of purchasing labels from the BSMI.

Products Covered: 2523.29. Other portland cements 2523.90 Other hydraulic cements

Regulation Type: Regular notification

Distribution date: 25 February 2022 | Final date for Comment: 26 April 2022

This East African Standard specifies technical requirements for ribbed bars to be used as reinforcement in concrete. This part of EAS 412 covers: a) ribbed bars supplied in straight lengths; and b) eleven steel grades not intended for welding which are, B500A- R, B500B-R, B500C-R, B600A-R, B600B-R, B600C-R, B600D-R, B700A-R, B700B-R, B700C-R and B700D-R, and six steel grades intended for welding which are, B500AWR, B500BWR, B500CWR, B500DWR, B550DWR and B600DWR This standard does not apply to ribbed bars produced from finished products, such as plates and railway rails.

Products Covered: Bars and rods, hot-rolled, in irregularly wound coils of iron or non-alloy steel, with indentations, ribs, grooves or other deformations produced during the rolling process (HS code(s): 721310); Concrete structures (ICS code(s): 91.080.40)

Regulation Type: Regular notification

Distribution date: 25 February 2022 | Final date for Comment: 26 April 2022

This East African Standard specifies technical requirements for ribbed bars to be used as reinforcement in concrete. This part of EAS 412 covers: a) ribbed bars supplied in straight lengths; and b) eleven steel grades not intended for welding which are, B500A- R, B500B-R, B500C-R, B600A-R, B600B-R, B600C-R, B600D-R, B700A-R, B700B-R, B700C-R and B700D-R, and six steel grades intended for welding which are, B500AWR, B500BWR, B500CWR, B500DWR, B550DWR and B600DWR This standard does not apply to ribbed bars produced from finished products, such as plates and railway rails.

Products Covered: Bars and rods, hot-rolled, in irregularly wound coils of iron or non-alloy steel, with indentations, ribs, grooves or other deformations produced during the rolling process (HS code(s): 721310); Concrete structures (ICS code(s): 91.080.40)

Regulation Type: Regular notification

Distribution date: 25 February 2022 | Final date for Comment: 26 April 2022

This East African Standard specifies technical requirements for ribbed bars to be used as reinforcement in concrete. This part of EAS 412 covers: a) ribbed bars supplied in straight lengths; and b) eleven steel grades not intended for welding which are, B500A- R, B500B-R, B500C-R, B600A-R, B600B-R, B600C-R, B600D-R, B700A-R, B700B-R, B700C-R and B700D-R, and six steel grades intended for welding which are, B500AWR, B500BWR, B500CWR, B500DWR, B550DWR and B600DWR This standard does not apply to ribbed bars produced from finished products, such as plates and railway rails.

Products Covered: Bars and rods, hot-rolled, in irregularly wound coils of iron or non-alloy steel, with indentations, ribs, grooves or other deformations produced during the rolling process (HS code(s): 721310); Concrete structures (ICS code(s): 91.080.40)

Regulation Type: Regular notification

Distribution date: 25 February 2022 | Final date for Comment: 26 April 2022

This East African Standard specifies technical requirements for ribbed bars to be used as reinforcement in concrete. This part of EAS 412 covers: a) ribbed bars supplied in straight lengths; and b) eleven steel grades not intended for welding which are, B500A- R, B500B-R, B500C-R, B600A-R, B600B-R, B600C-R, B600D-R, B700A-R, B700B-R, B700C-R and B700D-R, and six steel grades intended for welding which are, B500AWR, B500BWR, B500CWR, B500DWR, B550DWR and B600DWR This standard does not apply to ribbed bars produced from finished products, such as plates and railway rails.

Products Covered: Bars and rods, hot-rolled, in irregularly wound coils of iron or non-alloy steel, with indentations, ribs, grooves or other deformations produced during the rolling process (HS code(s): 721310); Concrete structures (ICS code(s): 91.080.40)

Regulation Type: Regular notification

Distribution date: 25 February 2022 | Final date for Comment: 26 April 2022

This East African Standard specifies technical requirements for ribbed bars to be used as reinforcement in concrete. This part of EAS 412 covers: a) ribbed bars supplied in straight lengths; and b) eleven steel grades not intended for welding which are, B500A- R, B500B-R, B500C-R, B600A-R, B600B-R, B600C-R, B600D-R, B700A-R, B700B-R, B700C-R and B700D-R, and six steel grades intended for welding which are, B500AWR, B500BWR, B500CWR, B500DWR, B550DWR and B600DWR This standard does not apply to ribbed bars produced from finished products, such as plates and railway rails.

Products Covered: Bars and rods, hot-rolled, in irregularly wound coils of iron or non-alloy steel, with indentations, ribs, grooves or other deformations produced during the rolling process (HS code(s): 721310); Concrete structures (ICS code(s): 91.080.40)

Regulation Type: Regular notification

Distribution date: 24 February 2022 | Final date for Comment: 24 February 2022

The Ministry of Food and Drug Safety, Republic of Korea intends to revise the Korean Herbal Pharmacopoeia as follows: [Attached Table 4.] Ⅳ. Pharmaceuticals each paragraph, Revised the total Polyphenol content of  ‘Grape Leaf Dry Extract’ and ‘Grape Leaf Dry Extract Capsules’

Products Covered: Pharmaceuticals

Regulation Type: Regular notification

Distribution date: 24 February 2022 | Final date for Comment: 25 April 2022

The executive order regulates construction and marking of toys. The executive order contains among others chemical requirements on toys.

Products Covered: Toys

Regulation Type: Revision to Regular Notification