FROM THE FIELDS PHARMACEUTICALS PTY LTD
REGULATORY & QUALITY FRAMEWORK
Quality-controlled supply within Australia's regulatory framework
From the Fields Pharmaceuticals is committed to quality-managed processes at every stage of the product lifecycle — from technical specification through to pharmacy supply and post-market surveillance.
We define what our products must be, choose partners we can verify, test independently, notify the TGA on the public record, publish clear patient documents and supply exclusively through pharmacy. Each stage is described below.
Stage 01 — Our approach
We define exactly what each product must be before it is made
Every product FTFP sponsors begins with a comprehensive technical specification — written and owned by us. We align the device, the substance, the concentration, the permitted flavours and the sourcing standards for every ingredient. Nothing goes to a manufacturing partner without a specification we stand behind.
This is not a box-ticking exercise. Our specifications are the reference point for everything that follows — manufacturing, testing, TGA notification and labelling. If a specification changes, the downstream process restarts.
Device specification
We define the physical and mechanical parameters of the device — materials, airflow, delivery characteristics — before any manufacturing begins.
Substance specification
We define the API, excipients, concentration and flavour profile to pharmacopeial and EU standards. Flavours are limited to Tobacco / Mint / Menthol.
Therapeutic scope only
Our specifications are written for a single purpose: smoking cessation and management of nicotine dependence. No recreational framing. No lifestyle positioning.
What we do
- Specifications documented and version-controlled — any change triggers a full downstream review
- Flavour restricted to Tobacco, Mint & Menthol — no exceptions at any concentration
- Nicotine concentration defined to schedule — ≤20mg/mL for S3, above that for S4 prescribing pathway
- API and excipient sourcing standards specified in writing before engagement of any supplier
How this aligns with the framework
The TGA requires sponsors to confirm their product is intended only for smoking cessation or nicotine dependence management, and that it meets applicable product standards. Our specifications are what make that confirmation possible.
Stage 02 — Our approach
The standards we hold ourselves and manufacturing partners to
FTFP does not manufacture products. We ensure the standards set and agreed to are met and verified and reviewed on an ongoing basis. The certificates below are not our aspirations, they are requirements.
Required certifications
ISO 13485
Medical devices quality management
Required of our device partners. Covers design controls, production processes, traceability and post-market feedback — ensuring the device performs as specified throughout its lifecycle.
ISO 9001
Quality management systems
Required of our substance manufacturing partners. Establishes documented process controls, non-conformance management and continual improvement obligations across the manufacturing operation.
ISO 14001
Environmental management
Required of all manufacturing partners. Confirms that environmental impacts — waste, emissions, energy use — are identified, monitored and managed under a documented system.
ISO 45001
Occupational health & safety management
Required of all manufacturing partners. Covers hazard identification, risk controls and worker safety obligations — ensuring the environments that produce our products are safe and well-managed.
SA 8000
Social accountability
Required of all manufacturing partners. Prohibits forced labour, bonded labour, child labour and unsafe working conditions. FTFP verifies compliance — it is not accepted on a partner's assertion alone.
HACCP
Hazard analysis & critical control points
Applied to substance manufacturing. Identifies biological, chemical and physical hazards at every stage of production and establishes documented controls at critical points — supporting ingredient integrity.
cGMP
Current good manufacturing practice
Required of all substance partners. Covers batch records, contamination controls, environmental monitoring and release testing — aligning production to pharmaceutical-grade manufacturing standards.
What we do
- Current certification to each required standard verified at partner onboarding — certificates of conformance held by FTFP
- Certification renewal dates tracked — lapsed certification triggers an immediate supply review
How this aligns with the framework
The TGA holds sponsors — not manufacturers — responsible for product compliance. Our partner requirements mean that responsibility is matched by real oversight, not delegated and forgotten.
Stage 03 — Our approach
We test our products to ISO 17025 standards
FTFP requires all product testing to be conducted by laboratories that are accredited to ISO/IEC 17025. The accreditation means the lab's methods, equipment and personnel have been independently assessed. The test reports we hold are objective evidence, not reassurance.
Emissions characterisation
What the aerosol actually contains when the device is operated — identified and quantified under defined conditions.
Toxicology assessment
Identified substances assessed against inhalation toxicology thresholds. Objective parameters — not clinical claims.
Substance purity
API and excipient identity and purity confirmed against specification. Prohibited substances verified absent.
Device performance
Consistent delivery, no leakage, battery safety, coil temperature within specified range — verified independently.
What we do
- All testing through ISO/IEC 17025 accredited laboratories
- Test reports reference the specific batch and specification version — not generic product type
- Retesting required whenever specification changes, formulation updates or manufacturing partner changes
How this aligns with the framework
TGO 110 sets quality and safety standards for therapeutic vaping goods. Our independent test reports are the evidence base that supports TGA notification and that we hold available for post-market review. We don't commission reassurance — we commission evidence.
Stage 04 — Our approach
We notify the TGA for every product — before it enters Australia
No FTFP product is imported or supplied in Australia without a completed TGA notification, and ODC permit. This is not an administrative formality — it is FTFP confirming, on the public record, that a specific product meets applicable standards. Our name is on the notification. Our reputation is on the list.
The TGA maintains a public list of notified therapeutic vaping goods. Our products are on it. If they are ever removed, supply stops immediately. That is the commitment that notification represents.
Sponsor notice
FTFP's formal confirmation to the TGA — on our name — that the product meets applicable standards and is intended only for the permitted therapeutic indications.
Technical dossier
The full package behind the notice: specifications, manufacturing certifications, independent test reports, labelling and CMI drafts. This is what backs the claim.
Public notified list
Our products appear on the TGA's publicly available notified vaping goods list. Anyone can check. That transparency is deliberate — it keeps us accountable.
What we do
- Notification submitted and confirmed before any product is imported or supplied — no exceptions
- All FTFP products verified on the TGA notified list before supply commences
- Re-notification submitted for any material change to specification, formulation or manufacturing partner
- TGA sample requests fulfilled within required timeframes
How this aligns with the framework
Under the Vaping Reforms Act 2024, notification is a pre-condition for lawful supply. We treat this not as the minimum bar but as the public expression of our quality commitment — a statement we stand behind on the public record.
Stage 05 — Our approach
We publish clear, current and accessible documents for every patient
Every patient who receives an FTFP-sponsored product deserves to know what it contains, how to use it and what to do if something goes wrong. That is what Consumer Medicine Information (CMI) and Instructions for Use (IFU) documents exist for. We take responsibility for keeping them accurate, current and genuinely accessible.
CMI and IFU documents for our products are published through the relevant brand sites and provided by pharmacists at the point of dispensing. When specifications change or new safety information emerges, documents are updated before supply continues.
Product labelling
Labels carry everything a dispensing pharmacist and patient need. Reviewed against current standards before every production run — not just at launch.
Consumer Medicine Information
What this product contains. How to use it. Side effects. What to watch for. What to do in an emergency. Written for patients, not regulators.
Instructions For Use
Step-by-step device instructions, maintenance, troubleshooting and safety. Designed so a first-time patient can use the device correctly and safely.
What we do
- All labelling reviewed against TGO 110 and current standards before each production run
- CMI and IFU reviewed for accuracy against current notified specification — not just at product launch
- Documents accessible at wildbyinstinct.com and bion.com.au at all times for dispensed patients
- Documents updated before supply continues whenever specification, safety data or requirements change
How this aligns with the framework
Sponsors are responsible for ensuring product labelling and CMI comply with TGA requirements. We treat this as a patient obligation, not a regulatory one — the framework and our values arrive at the same place.
Stage 06 — Our approach
We supply through pharmacies. That is the only channel we use. Full stop.
This is not a positioning statement — it is how FTFP operates. Our products do not go through illegal channels. They reach patients through online & community pharmacies, under the supervision of a healthcare professional, where clinically appropriate.
That pharmacy relationship matters beyond legal compliance. A pharmacist dispensing an FTFP product provides the CMI, answers questions and — critically — can assess whether this product is appropriate for this patient. That oversight is not something we work around. It is something we depend on.
Schedule 4 — prescription
For products above 20mg/mL nicotine. A valid prescription from an authorised prescriber is required. Our supply chain ends at the licensed pharmacy dispensing it.
Schedule 3 — pharmacist supply
For products at 20mg/mL or below. From October 2024, eligible adult patients may access via pharmacist assessment, in all states except WA & Tas.
Post-supply monitoring
Supply is not the end of our obligation. Adverse event monitoring and supply chain surveillance continue for as long as our products are on the market.
What we do
- Distribution through licensed pharmaceutical wholesalers only — no non-pharmacy channels under any circumstances
- Anti-diversion provisions in all distributor and pharmacy supply agreements — enforceable, not aspirational
- Supply monitored — concerns about diversion outside the lawful pathway trigger immediate review
- Adverse events reported to TGA within required timeframes
How this aligns with the framework
Under the Vaping Reforms Act 2024, supply through any channel other than authorised pharmacy is a criminal offence. Our position is not that we comply with this requirement — it is that pharmacy-only supply is what we believe responsible access looks like, and the legislation reflects that.