Technical Alerts

CMA is pleased to provide the following regulatory updates that represent the work of its member committees and working groups.

Updates include:

• ·         TGA approach to Compositional Guidelines
• ·         CMA Regulatory Policy Committee
• ·         New substances proposed for expedited evaluation
• ·         NZ Health & Supplementary Products Bill workshop update
• ·         IADSA Regulatory update
• ·         Current calls for comment

Please contact Emma Burchell via Emma.Burchell@cmaustralia.org.au or phone: (02) 6260 4022 for further information or feedback.

Click here to read the update.

The EU has revised Chapter 1, 2, 6 and 7 of the EU GMP Guide on “Quality Systems”, “Quality Control” and “Outsourced Activities”, respectively. As the PIC/S and EU GMP Guides must remain aligned, and requirements should be equivalent, the PIC/S Secretariat has prepared a revision of the same chapters of the PIC/S GMP Guide (applicable to Australian manufacturing).

CMA therefore invites members to consider the proposed changes and identify where any revisions may be inappropriate for the complementary medicines sector, so that we may flag these with our CM technical working group in consideration of developing specific Australian guidance documentation as required.

Please send your comments to submissions@cmaustralia.org.au by Friday 31, July 2015.

Click here for the Alert

The TGA has been producing half yearly performance reports (HYPR) since 1992. Through the development of the new key performance indicators (KPIs) under the Regulator Performance Framework, the TGA has considered its entire reporting framework, including the production of the HYPR. Industry feedback to date has been that these reports are valued and should be continued..
However, your feedback is sought on how to make the HYPR a more concise and valuable document.

Click here to read the alert and provide your feedback.

The TGA has informed CMA of the outcomes of compliance reviews for medicines containing the ingredient Euphausia superba (Krill) Oil.
It is CMA’s intention that by highlighting the information contained in this alert it may assist sponsors to review the evidence to support indications for krill oil and voluntarily make any corrective actions that may be required.

Click here to read the Alert

The TGA has informed CMA that effective 30 June 2015, a new condition of listing will be imposed on medicines containing the ingredient Euphausia superba (Krill) Oil.


Click here to read the alert

CMA has welcomed the publication of the Deregulation Discussion Document by the Government’s Independent Expert Panel. Flagged in the announcement of the panel last year, the complementary medicines chapter has been published as an addendum to the review discussion paper and outlines several critical areas for industry to consider.

Call for comments: Members are invited to provide responses to the discussion paper directly to CMA via submissions@cmaustralia.org.au by Friday 27 March.

Click here to read the Alert

CMA is calling for your feedback on two European Union guidelines proposed for adoption by the TGA. Comments can be made via a prepopulated form within this alert and sent to submissions@cmaustralia.org.au by Friday 27 March 2015.

These updates takes into account new and revised guidelines, the European Pharmacopeia revised general monograph ‘herbal drugs’, as well as new requirements for impurities.

Click here to read and respond to the Alert. 

Complementary Medicines Australia (CMA) is the peak body for the complementary healthcare products industry and supports compliance with Australian law by complementary medicine healthcare practitioners. We are writing to practitioners to alert them to risks related to the importation of overseas products: risks both to patients and to professional practice.

To read the Alert click here.

During 2014 the TGA commenced a policy and operational review of the Low Value Turnover scheme. The TGA has now considered the consultation responses and proposes a new scheme.  Given the potential impact on a broad range of charges, it is important that each sponsor consider the impact of the proposed LVT scheme on their product/s.

To read the alert and respond click here.

To improve and facilitate the process of notifying the TGA about sponsor transfers, the TGA are proposing to publish explanatory material that describes the relevant legislative provisions in the Regulations and the process for notifying TGA about such changes as well as updated, simplified forms.

Members are invited to provide feedback on this material before COB Friday, 23 January, 2015.

Click here to read the Alert.