Recommendations are detailed in guidance issued by the Food and Drug Administration (FDA), as outlined in our 'What is a PMTA?' article. In summary, ENDS companies are required to submit an application for new and/or existing products, in the form of a product dossier. This is expected to detail studies undertaken in 3 key compliance areas:
The projected timescale for compilation of a validated submission is up to 10 months, and the deadline for submission is May 12, 2020.
This applies to all companies producing e-liquids, aerosolizing apparatus and combined ENDS products that would like to continue to sell their products in the US after the deadline.
Phase 1. Planning
Planning is an important first step – whether you have already decided to progress down the PMTA pathway or are still considering your options.
For companies that know this route is for them, now is the time to put together a project team aligned with your business culture and marketing objectives. Based on the project scope, a comprehensive plan will be established, with a governance structure and delivery milestones.
For companies that have yet to commit to the full process, it’s important to seek initial advice and consider what your PMTA strategy could look like, to facilitate the decision-making process.
Either way, your assembled project team, comprising experienced scientific and regulatory experts acting as PMTA Workstream Leads, will work with you to optimize your product range. We’ll identify the products that are most likely to achieve PMTA approval or establish new product development needs.
Embarking on a PMTA journey to successfully deliver a marketing authorization granted by FDA, for a set of SKUs capable of commercialization, requires significant commitment and investment in terms of time and capital. As with any ROI venture, it is important to gather key information early in the process to make informed decisions on selecting PMTA candidate products that demonstrate the highest levels of quality, safety and commercial viability.
Consultation and engagement with FDA is a critical stage in this planning process. FDA only intend to offer one or two scientific advisory meetings to each ENDS company. It’s therefore important to make sure these meetings are planned effectively, to maximize learnings and gain feedback on your specific scientific studies. Broughton Nicotine Services provide experienced Workstream Leads across all PMTA scientific areas, to accompany you at your FDA advice meetings.
Phase 2. Compilation
This stage involves the extensive compilation of scientific data. You will be assigned a dedicated Project Manager, who’s role will be to manage the full PMTA process on your behalf, liaising with experienced Workstream Leads for each of the 3 key compliance areas. Alternatively, companies with internal Workstream Leads can supplement their in-house capabilities with a tailored solution.
Product analysis and manufacturing studies – Scientific product analysis and a Chemistry, Manufacturing and Controls (CMC) evaluation, undertaken by our Contract Research Organization (CRO).
Non-clinical studies – Detailed assessment of the toxicological and pharmacological profile of your products.
Human subject studies – Clinical studies undertaken with your specific products, in order to determine their potential impact on public health.
Studies undertaken in the 3 key compliance areas are highly inter-related - so timing and co-ordination of activities is critical to maximize synergies across the studies.
Scientific bridging strategies developed by our team of ENDS specialists will reduce the levels of testing and studies required in all areas, hence maximizing the cost-effectiveness of your PMTA.
Phase 3. Submission
This important final phase of the PMTA program involves authoring, formatting and publication of your submission documents. Significant investment is made into generating scientific data for a regulatory submission, so you’ll want to make sure this stage is executed successfully. All data, whether paper or electronic, must comply with strict FDA guidelines on data integrity and follow Good Documentation Practice (GDP).
Your Project Manager and team of Workstream Leads will generate submission-ready documents across all scientific studies for each of the 3 key compliance areas. Complying with well-established Electronic Records and Electronic Signatures (ERES) and electronic submission standards dictated by the FDA, is an important part of this final stage.
Our unique data management system, developed specifically for this purpose, will provide both you and the FDA with reassurance in terms of data accuracy, integrity and transparency.
The PMTA deadline has recently been brought forward to May 2020, as our 'The 10-month deadline is confirmed' article explains. In response to this, our team have identified the studies that are essential for your business to achieve a validated submission. We recommend focusing on these priority studies upfront, and then supplementing with additional data required during the PMTA review period. An efficient, agile approach will be essential to ensure the required studies are undertaken effectively prior to the compliance deadline.
Broughton Nicotine Services operate exclusively in the ENDS sector. Our team of scientific and regulatory experts, backed by an in-house, custom-built Contract Research Organization (CRO) facility, understand your specific challenges and opportunities. This enables us to provide an:
With expertise across US and EU markets for tobacco-products, medical devices and pharmaceuticals, we are committed to working with you to increase the value of your business and advance a smoke-free future.
Leaflet
Overview of our full-service PMTA compliance solution, from planning through to compilation and submission.
Guide
Understand what’s involved in a PMTA and how the recommendations relate to your ENDS business.
Leaflet
Download our leaflet for an overview of our comprehensive services to support the ENDS industry from regulatory submission to maintaining compliance.
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