August 2024 Industry update

A lot can happen in a month, here’s some of the latest regulatory developments in the industries we serve with some narrative.

Animal Health – Australia (APVMA)

Your comments on the proposed update to the APVMA GMP audit procedure

New Minister for Agriculture, Fisheries and Forestry

The Hon. Julie Collins replaces The Hon. Murray Watt as of 29/7/2024
a former Shadow Minister for Agriculture when Labor were in opposition, so she is across some of the issues affecting the industry;
mixed opinions on the appointment have been shared from both sides of politics

New APVMA leadership now in place

New APVMA CEO Mr Scott Hansen started with the APVMA on 24/7/2024
Dr Catherine Ainsworth has commenced her appointment to the role of APVMA Board Chair since mid-July.
Looking forward to the promised strong leadership and governance arising from the various reviews

Keep on top of manufacture sites in your APVMA product files

Clients are reporting letters from the APVMA requesting updates to manufacture sites for products as the sites in the product register do not have a current APVMA manufacturing licence
Main cause is manufacturers, particularly laboratories may have changed address over time
Australia does not have a regular review period for registrations, these details can missed
The update process is quite straight forward, Item 13A/ $175 (per product)/ approx. 1 month turnaround
Pia Pharma analytical service and regulatory clients, contact us for a special rate to update your records

Keep an eye on your MLS audit close out timeframe

Clarification of recall process for Agvet chemicals

Great opportunity to reacquaint with the recalls process, particularly responsibilities of the holder, reporting timeframes and forms, read more here;
Best communication method is , the phone number is the general ‘answering machine’;
Keep on top of your mock recalls and update SOPs with clarified guidance if required, auditors will check;
Links to Recall Guidance (2017) still active and current

Watch this space – APVMA GMP code review underway

The APVMA are intent on contemporising the Australian Code of Good Manufacture Practice for Veterinary Chemical Products;
Review underway using several ‘undisclosed’ reviewers;
First proposed amendments through the APVMA Industry Liaison Committee sometime in September or October 2024;
More to say about this when we have a few more details.

Dr Tanita Wierenga moves to Manufacturers’ Licensing Scheme (MLS)

Tanita has moved out of APVMA Chemistry
now Assistant Director of MLS as the APVMA backfill after Sam Becketts departure;
No news on replacement in Chemistry, expect delays with reviews
Keep an eye on the technical Chemistry questions, always a challenge with inexperienced evaluators;
Useful link to the APVMA Risk Assessment Manual for Chemistry and Manufacture
Call us if you need assistance

Pharmaceuticals – Australia (TGA)

Nitrosamines in Medicines – Update to Acceptable Intake

The TGA has published updated acceptable intake (AI) information for nitrosamine impurities in medicines consistent with recent EMA information.
Sponsors and manufacturers are expected to be familiar with the current acceptable intakes (AI) for nitrosamine impurities in medicines;
Pia Pharma has experience with trace level nitrosamines in pharmaceutical products

Animal Health – New Zealand (ACVM)

ACVM Annual Workshop (31/7/2024)

Good attendance at this seminar
Copy of the ACVM Workshop Presentations here
Best presentation goes to ‘How to submit a great application’ – I’ll be rereading that!

ACVM Workload update July