Technical Alerts

The Therapeutic Goods Amendment Bill No 1. of 2017 has received Royal Assent. The reforms are being implemented from today. More information here.

This technical alert advises implementation dates for reforms that were passed in the Therapeutic Goods Amendment Bill No. 1 of 2017, including permitted indications, the new Listed Assessed pathway, and advertising changes.

Included is a 1-minute anonymous survey to help develop an estimate on new pathway application numbers to assist with business planning procedures.
More information here.

The TGA have released a public consultation into GMP fees and charges which have been significantly under-recovered in recent years. They provide 3 options to address this. They have requested that where feasible, CMA and other industry associations collect industry responses and provide to the TGA. CMA is seeking a response by 26 Feb for TGA closing date of 5 March. For more details, please click here.

 

There is also a consultation on the remaking of the TGO 77 Microbiological Standards for Medicines without technical amendment.

The upcoming 50th Session of the Codex Committee on Food Additives will set new limits for the Codex GFSA.

On behalf of IADSA, CMA are seeking information from members to determine at which levels lower than those that will be proposed by the Electronic Working Group (EWG) would cause problems. In the event that the proposed levels are challenged, IADSA will need information or evidence from industry. For example, the EWG will be proposing adoption of tocopherols (INS307) at 2000 mg/kg with a derogation of 6000 mg/kg for fish/algal oil.

For more information and the IADSA form for industry, please click here.

This technical alert also includes information on new and updated TGA Compositional Guidelines.

The TGA has updated the Manufacturing Principles to the PIC/S Guide PE009-13 and published additional guidance for manufacturers.

In addition, the new Uniform Recall Procedure for Therapeutic Goods is active from today.

More information here.

The TGA has released a new Child-resistant packaging requirements for medicines, the Therapeutic Goods Order No. 95, which will replace the TGO 80. More information is available here.

The TGA has released a fifth Permissible Ingredients Determination for 2017, which is now included on the Federal Register of Legislation (FRL). It includes one new active probiotic ingredient for Listed Medicines. A combined volume of the six volume determination is included for CMA members in this update.

An amendment to the Therapeutic Goods Regulations has also been included on FRL, which allows for new kinds of notifications for Registered Complementary Medicines. The TGA Business Services online portal and guidance has been updated accordingly. For more details and links please click here.

The TGA has released information regarding the transition to the new PIC/S GMP code, including transitional arrangements and the effects upon manufacturing audits. A restructure of manufacturing fees and charges has been flagged and will be consulted over the coming months. For more information, please click here.

Today the TGA released a public consultation proposing significant changes to the regulation of Herbal Component Names. Find more information and a summary of the details here.

Please find a further update regarding permitted indications, including regulatory policy considerations, and the current discussion around biomarker claims. The technical alert is included here.