Market Access & HTA Strategy
Regulatory approval is not the finish line. Getting a product to patients means market entry infrastructure, HTA alignment, pricing and reimbursement, and coordinated launch execution across countries. We treat market access as an integral part of the development programme and not as a separate workstream that starts after approval. The regulatory team that oversees the clinical evidence strategy and compiles the submission also ensures that market entry considerations — from HTA evidence requirements to MAH infrastructure — are built into the plan from the start. For specialist health economics, pricing, and payer-facing work, we bring in dedicated experts, the same way we bring in CROs for trial operations or CDMOs for manufacturing.
Examples of How We Support
These are just examples to illustrate the kind of work we do day to day. The fastest way is usually a short call to understand your situation and discuss how we can help.
Market entry setup
You have an approved product and need to enter the EU, UK, or Swiss market, but you don't have a local entity, MAH infrastructure, wholesale licences, or named compliance roles. You need someone who can provide the regulatory and operational setup required to place a product on the market.
Multi-market launch coordination
You're planning a launch across multiple EU member states and need to coordinate national pricing and reimbursement submissions alongside the regulatory work. You need a partner who understands both sides of the equation and can connect the regulatory timeline with the market access timeline.
EU JCA strategy
The EU HTA Regulation now applies to your product and you need to understand how Joint Clinical Assessments (JCA) affect your evidence strategy, your submission timing, and your pricing discussions at the national level.
Market access due diligence
You're evaluating a product for in-licensing or acquisition and need to understand the market access landscape: which countries can you enter, what are the reimbursement prospects, and what regulatory infrastructure is needed to commercialise.
Consolidated lifecycle support
You have products on the market but the commercial and regulatory maintenance is fragmented across multiple service providers. You want one partner coordinating lifecycle management, pharmacovigilance, quality, and market access activities across your portfolio.
Understanding Market Access & HTA Strategy
We use "market access" broadly. It covers everything between regulatory approval and a product being commercially available to patients: the regulatory infrastructure (MAH, licences, compliance roles), pricing and reimbursement, HTA assessments, tender processes, market insights, supply chain setup, and multi-country launch coordination. Some companies call this "market entry".
The EU HTA Regulation has made it very clear that market access cannot be separated from the regulatory program anymore. Joint Clinical Assessments (JCA) mean that clinical trial design, comparator selection, and endpoint strategy must satisfy both regulatory authorities and HTA bodies simultaneously. This has to be a regulatory-led process and cannot be a "commercial afterthought". The same team that designs the regulatory strategy needs to ensure that market access considerations are embedded from the start.
At the same time, health economics, value dossier authoring, and payer negotiations are specialist disciplines. They require dedicated expertise, just as clinical trial operations require CROs and manufacturing requires CDMOs. We bring in specialist market access partners for this and work hand in hand with them as part of the overall programme — a model we have practised for several decades within regulanet®.
What We Do
Market entry requires regulatory infrastructure, commercial planning, and multi-country coordination working in parallel. Here's what we deliver in practice:
Our Workstreams
Market access engagements typically combine infrastructure, regulatory coordination, and commercial planning. The scope depends on whether you need a full market entry programme or support for a specific workstream.
Market Entry Infrastructure
MAH setup and registration across EU member states, UK, and Switzerland. WDA and MIA applications. Support for client WDA applications, including RP appointment on the client's licence. Named QP, EU QPPV, Stufenplanbeauftragter, and DIO/Scientific Service on existing licences. GDP-compliant storage and distribution. Supply chain qualification.
Launch Readiness & Coordination
Pre-launch gap analysis (regulatory, PV, quality, supply chain). Labelling and packaging coordination across languages and markets. Coordination of regulatory and P&R submission timelines. National market entry sequencing.
HTA & Evidence Alignment
EU HTA Regulation readiness. Our specialist market access partners lead the HTA-side analysis: PICO assessment, comparator selection, evidence-gap analysis, value dossier authoring, and national HTA submissions (G-BA/AMNOG, NICE, HAS, AIFA, and others). We integrate this workstream within the wider program, author the EMA-side of parallel EMA/HTACG scientific consultation briefings, and integrate the HTA evidence requirements into the regulatory and clinical plan. For medical devices, we coordinate national engagement (NICE Medtech Innovation Briefings, G-BA device evaluations) with our partners and prepare for EU JCA scope from 2026 onwards for selected high-risk devices.
Pricing & Reimbursement
Reimbursement dossier authoring and payer negotiations are partner-led in most engagements. We sometimes execute national pricing and reimbursement submissions ourselves where the market and the engagement allow it. In all cases we manage the workstream within the wider program and align launch sequencing across markets to optimise reference pricing outcomes. International reference pricing impact assessment is run with our partners.
Portfolio Strategy & Business Development
Portfolio gap analysis and licensing-in/out opportunity identification. Regulatory feasibility assessment for target markets and product types. Product transfer and MA acquisition support. Market expansion planning for existing portfolios.
Global Market Access via regulanet®
Multi-country registration and launch coordination through our network in 90+ countries. Local regulatory and market access support adapted to national requirements.
Where This Fits in the Development Journey
Market access thinking needs to start early and intensifies around approval and launch.
Design & Development
Integrate payer evidence requirements into clinical programme design. Begin HTA landscape assessment for target markets. Identify potential JCA scope for applicable products.
Clinical
Align clinical evidence generation with HTA and payer requirements. Coordinate parallel EMA/HTACG scientific consultations (with partners). Plan comparator and outcome data collection for future P&R submissions.
Regulatory Submission & Approval
Prepare market entry infrastructure in parallel with the regulatory submission. Set up MAH, licensing, and compliance roles before MA grant. Begin national P&R submission preparation.
Launch & Market Access
Activate MAH and distribution infrastructure. Coordinate national P&R submissions with partners. Manage labelling, packaging, and supply chain for commercial launch. Execute multi-country launch via regulanet®.
Post-Market & Lifecycle Management
Manage ongoing P&R obligations and renewals. Support lifecycle market access activities (new indications, line extensions, Rx-to-OTC switches). Coordinate portfolio expansion into new markets.
Product Type Considerations
Market access requirements differ by product type, especially in how pricing and reimbursement systems evaluate value.
Pharmaceuticals (Innovative)
National P&R submissions required in most EU markets post-MA. Reference pricing systems mean launch sequence and pricing decisions in early markets affect all subsequent countries. For oncology and ATMPs, EU JCA findings feed into national P&R assessments from 2025.
Medical Devices
Market access for devices operates through different mechanisms than pharmaceutical P&R. National reimbursement depends on product coding systems, formulary or catalogue listing, and hospital-level procurement and tender processes that vary by country and device category. From 2026, selected high-risk medical devices are in scope for EU Joint Clinical Assessments under the HTA Regulation. For innovative devices, early engagement with national HTA bodies can shape evidence requirements and accelerate reimbursement. We coordinate device market access with our specialist partners.
Combination Products
Dual market access challenge: drug pricing/reimbursement and device procurement may follow separate pathways. Coordinated strategy needed across both.
Pharmaceuticals (Generics)
Market entry driven by price competitiveness and supply chain reliability. Regulatory infrastructure (MAH, WDA) is the primary barrier. Faster to market if the MAH and distribution setup is already in place.
Digital Health & SaMD
Specific national pathways: DiGA (Germany), PECAN (France), DTAC (UK). Clinical evidence requirements for reimbursement differ from regulatory requirements for CE marking. Early alignment between clinical validation and payer evidence is critical.
Sample Deliverables
The deliverables depend on whether the engagement is regulatory infrastructure, HTA/pricing coordination, or portfolio strategy.
MAH and distribution infrastructure setup package: MAH registration documentation, WDA/MIA applications, RP/QP appointments, and GDP compliance documentation for a specific EU market or set of markets. 
Market access readiness assessment: gap analysis covering regulatory, PV, QMS, and reimbursement readiness for a product launch in target EU markets, with timeline and action plan. 
Launch coordination plan: sequenced timeline for MA transfer (or initial MA), national P&R submissions, labelling, packaging, and first commercial supply across multiple countries. 
HTA evidence alignment report (with partners): assessment of clinical evidence against EU JCA PICO requirements, identification of evidence gaps, and recommendations for clinical programme adjustments. 
Parallel Joint Scientific Consultation (JSC) briefing package: aligned question set, EMA-side briefing authored by us, HTA-side material from our partners integrated into a single submission, and a post-consultation implementation plan for the clinical programme.
Portfolio analysis and market entry feasibility report: regulatory and commercial assessment of target products for EU/UK/CH market entry, including licensing pathway, infrastructure requirements, and timeline estimates. 
National P&R submission packages (prepared by partners, coordinated by regenold): value dossiers, health economic models, and payer briefing documents for target markets. Example Projects
Non-EU Pharma: Full Market Entry for a Marketed Product Across 8 EU Countries
A company outside Europe needed to commercialise an already-approved product in 8 EU member states. We acted as MAH on our own licences, provided the EU QPPV and local Scientific Service (Stufenplanbeauftragter / Drug Information Officer), supported the establishment of the client's wholesale infrastructure with an RP appointment on its WDA, and coordinated GDP-compliant distribution and labelling across the markets. Our market access partners prepared and submitted national P&R dossiers in parallel. The product reached commercial availability in the first 3 markets within 5 months of MA transfer.
Entering the EU Market, Planning a Multi-Country Launch, or Need Market Access Infrastructure?
Tell us about your products and target markets, and we'll outline how we can help.
Speak with an ExpertKey Regulations & Guidance
These frameworks govern HTA assessment, pricing and reimbursement, and market access across our work:
Frequently Asked Questions (FAQ)
Do you handle HTA dossiers and pricing negotiations directly?
Health economics, value dossier authoring, and payer negotiations are specialist disciplines that require dedicated expertise. We bring in specialist market access partners for this work, the same way we bring in CROs for clinical operations or CDMOs for manufacturing. We coordinate the overall programme: we ensure the clinical evidence, the regulatory strategy, and the market entry infrastructure are designed with HTA and pricing requirements built in from the start. The EU HTA Regulation has made this integration non-optional.
What market entry infrastructure can you provide directly?
We act as MAH on our own licences and operate MIAs in our Irish offices, with a Swissmedic establishment licence in Switzerland. We provide named QPs for batch certification, EU QPPVs, local QPPVs, Stufenplanbeauftragter, and Drug Information Officer / Scientific Service through these. Where the client establishes its own WDA, we support the application and the inspection and provide a Responsible Person to sit on the licence. GDP-compliant storage and distribution are arranged through our network. For non-EU companies, this means you can enter the European market without setting up your own local entities or recruiting compliance staff.
How does the EU HTA Regulation affect my market access strategy?
The EU HTA Regulation introduced Joint Clinical Assessments (JCAs) that produce EU-wide clinical evidence evaluations. Since January 2025, JCAs apply to new oncology products and ATMPs. From 2026, high-risk medical devices are in scope. Orphan medicines follow in 2028, and all new medicines eligible for the centralised procedure from 2030. JCA reports feed into national P&R decisions but do not replace them. The practical impact: your clinical trial design, comparator selection, and outcome measures now need to satisfy both regulators and HTA bodies from the start.
Can you help with market access in countries outside the EU?
Yes, through regulanet®. Our network of independent development, regulatory, and market access service providers covers 90+ countries. For market access specifically, we coordinate local registration and market entry through network partners. For pricing and reimbursement in non-EU markets, our market access partner organisation provides additional coverage.
What is portfolio analysis and how does it relate to market access?
We help companies evaluate their product portfolios from a regulatory and commercial perspective: which products can enter which markets, what infrastructure is needed, what the regulatory pathway looks like, and where licensing-in or out opportunities exist. This is particularly relevant for PE-backed companies acquiring product portfolios, or for generics companies looking to expand their EU footprint. The portfolio analysis feeds directly into the market entry plan.
How do you coordinate between the regulatory submission and market entry?
We treat them as one programme, not two. The regulatory team that manages the submission also ensures market entry infrastructure is in place before the MA is granted. We align the P&R timeline with the submission timeline so that national pricing and reimbursement work begins as soon as the MA is issued. We coordinate the specialist market access partners within the same programme governance as the regulatory, clinical, and CMC teams. The alternative — where regulatory and market access are handled by different organisations with no coordination — typically adds months to the time between approval and commercial availability.
How does market access for medical devices differ from pharmaceuticals?
Device market access relies less on centralised P&R negotiations and more on national reimbursement coding, hospital procurement, and tender processes. Reimbursement pathways vary by country and device category — an implantable device, a diagnostic, and a digital health product each follow different routes. The EU HTA Regulation brings devices closer to the pharma model from 2026 with Joint Clinical Assessments for selected high-risk devices, but national reimbursement decisions remain separate. We work with our market access partners to navigate these pathways and coordinate them with the regulatory programme.