Technical Alerts

Click here to download the IADSA Newsflash March 2017

The TGA has published its consultation paper addressing a number of the recommendations from the Medicines and Medical Devices Regulation (MMDR) Review, with the closing date for submissions 28 March 2017.

Click here to read the alert

The Therapeutic Goods Administration (TGA) has released the delegates’ interim decisions for amending the Poisons Standard (the Standard for the Uniform Scheduling of Medicines and Poisons - SUSMP).

This relates to scheduling proposals initially referred to the November 2016 meetings of the Advisory Committee on Chemicals Scheduling (ACCS) and Advisory Committee on Medicines Scheduling (ACMS).

Please note that the closing date for further submissions is 16 February 2017

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination has now been registered on the Federal Register of Legislation (FRL). The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2017.

The Therapeutic Goods Administration (TGA) has approved the new Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2017 under Section 26BB of the Therapeutic Goods Act 1989. TGA anticipates that the updated Determination will be published and available on the Federal Register of Legislation (FRL) after 30 January 2017. CMA has also requested that TGA publish a forward plan for quarterly updates to the Ingredients Determination for 2017 to assist industry with business planning.


Click here to read more

The TGA is expecting to release public consultation papers to allow feedback on the implementation of the recommendations from the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR).

This Alert is to advise that the TGA has completed a safety evaluation of fennel oil, an ingredient used in a number of listed medicines. 

The TGA has advised CMA to inform our members of the status of a chemical substance manufacturer, which may be of relevance to our members.

The US FDA recently issued a warning letter to the Nippon Fine Chemical Company, an API and chemical substance manufacturer. The warning letter was issued due to the site’s personnel physically obstructing FDA inspectors and refusing to hand over documents for review. The FDA has also placed the site on import alert.

No medicines supplied in Australia nominate this site for API manufacture, however, the TGA is aware that some excipients may be sourced from there.

The TGA request that CMA members verify with your manufacturers whether any raw materials for their medicines are sourced from the Nippon Fine Chemical Company, and if so, undertake a risk assessment in light of the warning letter.

Health Canada is examining new approaches to the regulation of natural health products (self-care products), including refocusing the approval of health claims to those based on scientific evidence. 

The Health Canada online consultation for the Regulation of Self-Care Products is open through to 24 October, 2016.

The Therapeutic Goods Permissible Ingredients Determination No.2 of 2016 is published and includes 205 amendments to ingredients for use in listed complementary medicines.

A summary of the main changes is outlined as well as related resources for members.