Section 8S(1)(a) – Notice of proposal to refuse application

After an agonising wait during an evaluation, you receive communication from the APVMA that one or more aspects of your application has not met the criteria for the APVMA to support registration.  The wording can be intimidating, and generally if you do not wish to accept their option, the APVMA are required to issue an 8S notice, proposing to refuse […]

APVMA Top 20 Project – stepping in the right direction

The APVMA’s Top 20 project is looking at feasibility of developing tailored guidance material for common application types. In March Pia Pharma participated in the first Top 20 workshop along with fellow members of the VMDA, members of AMA, Accord and Crop Life.  A key outcome of the project is intended to be delivery of […]

The science of satisfaction

The APVMA registration process is evidence based, and APVMA satisfaction is reliant on provision of information to address statutory criteria to support the intended product, use or claim. Generating information requires an investment (time, money, emotion), and those in commercial operations realise there are limits to all of these. The objective is to generate information […]

APVMA registration – a lack of certainty is stifling development

Pia Pharma’s core businesses is the provision of high quality analytical and regulatory services, and delivering commercial outcomes for clients involved in agricultural and veterinary chemical product development. Our clients in generic and innovative development space frequently cite a lack of certainty of a favourable outcome from the APVMA regulatory review process as a major […]

GMP Series 1 – Understanding contributors to quality and accuracy in analytical measurement

In the first article of this series we focus on the importance of the quality systems underlying the analytical data produced by a laboratory involved in testing of manufactured medicinal product. The ability for a laboratory to produce data that accurately reflects the quality of the product being tested is paramount. Inaccurate results can be […]

Bioanalytical update

A harmonised guideline for conduct of blood level bioequivalence studies for veterinary chemical products – VICH GL52 is proposed for implementation at Step 7 by August 2016.  The APVMA  were non-committal in my communications with them late in 2015 about certain implementation aspects of the Guideline.  While Australia is not a signatory to VICH, we expect the […]

Introducing Lab Notes – a regular update from Pia Pharma

Lab Notes is our way of keeping you in the loop with our take on industry related technical or regulatory issues. Our news updates will share some of our industry experience, regulatory issues we’ve encountered and some of the ideas, solutions and services we’ve relied on to achieve a successful outcome for clients.  We hope you […]

Getting AgVet chemicals GHS ready

Fom 1 January 2017 most Australian states and territories will require workplace hazardous chemicals to be labelled in accordance with the Globally Harmonized System of Classification and Labelling (GHS). The GHS is an international system used to classify and communicate chemical hazards. Following adoption of the model Work Health and Safety Regulations in 2012, Australia […]

Staying on top of AgVet Regulation

Without question, at a time when the Government emphasis is on ‘red tape reduction’, the AgVet industry is operating in a period of unprecedented regulatory burden. Pia Pharma is committed to staying on top of the issues affecting chemical product regulation in this sector and making the system work. We’ve recently attended the APVMA update […]

Pia Pharma launches new website

Pia Pharma was established to assist clients to commercialise concepts in pharmaceutical, animal health and agrochemical industries. Now in our 5th year, the commercial success we are achieving for our clients is the direct result of listening to client needs, applying our core strengths of quality science, staying on-task and on time. As a result […]