The Access Consortium: Accelerating Global Access to Medicines
As medicines development becomes increasingly global, traditional country-by-country regulatory pathways can slow innovation and delay availability to the patient. The Access Consortium offers a different model — one rooted in collaboration, reliance and harmonisation — designed to streamline regulatory decision-making and support faster access to medicines across multiple jurisdictions.
Regulatory collaboration is no longer optional; it is essential. In this article, we explore the opportunity that the Access Consortium provides, and how a coordinated regulatory process helps shorten evaluation timeframes, reduce regulatory burden and the number of questions, and reach more markets faster with fewer resources.
As members of regulanet®, a network of regulatory affairs consultancies across more than 90 countries, the benefits of Access were quickly recognised to mirror our own approach – bringing together experts in each country and working closely together to bring safe and effective therapies to the market. By leveraging the expertise of the regulanet® network, clients benefit from a single, coordinated approach to managing these complex submissions. We help clients navigate local requirements, align submission strategies, and efficiently pursue approvals across multiple Access Consortium markets through one collaborative process.
What is the Access Consortium?
The Access Consortium is an international coalition of medicines regulatory authorities that collaborate to streamline regulatory assessment and accelerate patient access to safe, effective and high-quality medicines. It brings together five like-minded regulators:
- Therapeutic Goods Administration (TGA) — Australia
- Health Canada — Canada
- Swissmedic — Switzerland
- Health Sciences Authority (HSA) — Singapore
- Medicines and Healthcare products Regulatory Agency (MHRA) — United Kingdom
Originally formed in 2007 as the ACSS Consortium (Australia, Canada, Singapore and Switzerland), the group became the Access Consortium when the UK joined in October 2020, with formal participation in worksharing initiatives from January 2021.
The consortium's shared objective is to enhance regulatory cooperation and alignment, reducing duplication of effort while maintaining robust scientific and regulatory standards. Through this collaboration, the Access Consortium aims to support innovation and accelerate access to medicines for over 150 million patients across member countries. As members of regulanet®, a network of regulatory affairs consultancies across more than 90 countries, regenold quickly recognised the benefits of Access.
Strategic Vision and Objectives
The Access Consortium operates under a clearly articulated vision: to enable innovation, strengthen regulatory trust and speed up access to high-quality health products through collaboration and reliance.
This vision is formalised through the GROWTH Manifesto, which sets out six core principles underpinning all Access activities:
- Governance — upholding scientific rigour and strengthening regulatory trust
- Reliance — building confidence through shared assessments across the product lifecycle
- Openness — communicating transparently with industry and stakeholders
- Worksharing — aligning processes and exchanging regulatory expertise
- Transformation — enabling innovation through digitalisation and forward-looking approaches
- Harmonisation — sharing best practices and advancing regulatory science
Together, these principles support the consortium's ambition to become one of industry's preferred filing pathways for collaborative regulatory submissions.
The consortium's Strategic Plan 2025–2028 reinforces this direction, with priority objectives that include strengthening worksharing initiatives, expanding lifecycle collaboration, supporting regulatory innovation and improving engagement with stakeholders. A new cloud-based joint review workspace is also being introduced to enhance efficiency and coordination.
As detailed on the Access Consortium website, approximately 24 new active substances have been approved via the consortium, with all five markets represented — clear evidence of this vision coming to life.
Standout Benefits of Access
There are many strategic benefits to the Access Consortium for both industry and regulators. The key ones are described below.
Faster, More Efficient Access to Markets
By enabling parallel assessment across multiple jurisdictions, the Access framework reduces duplication and shortens timelines, helping sponsors reach patients sooner.
Predictability and Alignment
Early engagement with multiple regulators through joint pathways provides greater regulatory clarity and consistent expectations, particularly for complex or innovative medicines.
Resource Optimisation
Regulatory authorities share workloads and expertise, improving assessment quality while reducing pressure on internal resources.
Stronger Regulatory Trust
Reliance and shared assessment reinforce confidence among agencies, strengthening long-term collaboration across the full product lifecycle.
Lifecycle Collaboration
Access coordination extends beyond first approval to include post-marketing surveillance, GMP inspections, regulatory standards and reliance activities.
Working with regulanet® partners further simplifies the process, creating one group and a single point of contact to support submission across all five markets.
How Does It Work?
Through engaging with regulanet®, we can provide a Marketing Authorisation Holder (MAH) in each country and a centrally coordinated approach with local expertise — gaining marketing approval in five key markets with reduced resource and time.
Early Engagement Through Joint Pipeline Meetings
For companies developing innovative or complex products, the Access Consortium offers joint pipeline meetings, providing an opportunity to:
- Discuss upcoming development programmes
- Explore suitability for future worksharing submissions
- Help regulators plan for coordinated assessments
These meetings support earlier alignment and smoother progression into formal Access procedures. It should be noted that only prescription medicines will be considered under the Access pathway.
One Coordinated Team Across Five Markets
The Access Consortium streamlines regulatory review by enabling health authorities to collaborate, but sponsors remain responsible for managing the submission process across each participating jurisdiction.
While the scientific assessment is shared, each market maintains its own regulatory requirements, timelines, administrative procedures, and local obligations. Coordinating these activities across multiple countries requires careful planning, local expertise, and consistent project management.
For organisations without regulatory teams in every Access market, bringing together the right expertise can be resource intensive and increase the risk of delays, inconsistent submissions, and duplicated effort.
This is where a coordinated regulatory network can make a significant difference.
Rather than engaging multiple independent consultants across different countries, clients work with one coordinated project team that:
- Develops a unified regulatory strategy
- Coordinates submissions across participating markets
- Manages communications and timelines
- Provides local expertise and representation where required
- Supports regulatory activities throughout the product lifecycle
This collaborative model reduces operational complexity, improves communication, and allows sponsors to focus on developing innovative therapies while experienced regulatory professionals manage the submission process.
Frequently Asked Questions (FAQ)
How can Access help sponsors accelerate multi-market expansion?
Access enables participating regulators to collaborate on scientific assessments and share review activities across multiple jurisdictions. For sponsors, this can reduce duplication, support more efficient regulatory planning, and potentially accelerate access to multiple markets through coordinated review pathways.
Will Access give sponsors a single approval covering all participating countries?
No. Access is not a centralised approval pathway. Each participating regulator retains its own independent legal and regulatory authority and issues its own national marketing authorisation.
Will sponsors still need to manage country-specific regulatory requirements?
Yes. Although Access promotes greater harmonisation and worksharing, local requirements still apply. These may include country-specific labelling expectations, stability data, administrative documentation, local representation requirements and post-approval obligations. Working with expert consultants based within each participating country can help sponsors proactively manage these requirements.
Does Access simplify communication with health authorities during review?
Access can help streamline regulatory interactions by allowing agencies to align scientific questions and collaborate during assessment. However, sponsors will still need to follow most of the country-specific interactions and procedures during the application and review process. A coordinated regulatory group can help centralise communication and ensure rapid handling of regulatory processes across participating markets.
Can Access reduce overall regulatory timelines for sponsors?
Potentially, yes. By supporting parallel review activities and collaborative assessments, Access may help reduce some of the inefficiencies associated with fully independent national submissions. Actual timelines will still depend on factors such as dossier quality, product complexity, and the participating markets. Sponsors are often best positioned to realise these efficiencies when submissions, regulatory responses, and local market requirements are managed through a coordinated multi-country regulatory group.
What operational challenges should sponsors prepare for when using Access?
Successful Access submissions require strong coordination across multiple markets, including aligned dossier management, consistent response strategies and rapid handling of country-specific procedures and requirements. Sponsors should ensure they have sufficient regional regulatory coordination in place before initiating the procedure. They often benefit from working with an integrated regulatory group that can coordinate activities across all participating markets and reduce operational complexity.
Is a local entity required in each country to act as MAH?
Yes. A local entity is required in most countries to act as Marketing Authorisation Holder (MAH). This can be a barrier for many companies; however, the regulanet® group can provide both MAH and local regulatory support in each of the Access countries.
When does Access make the most strategic sense for sponsors?
Access may be particularly valuable for sponsors pursuing coordinated regional launch strategies, especially for innovative or complex products intended for multiple participating markets. Separate national filings may still be preferable where commercial priorities, launch sequencing, or regulatory strategies differ significantly between countries.
Do sponsors need to include all Access member countries in a submission?
No. Sponsors can choose which participating countries to include based on their commercial objectives, regulatory strategy, and market priorities. However, at least two jurisdictions are required.
Case Study: UK Client — NCE via Access Consortium
A UK-based client pursued a new chemical entity (NCE) through the Access Consortium without prior major-market approvals. The participating agencies were the Therapeutic Goods Administration (TGA) in Australia, the Health Sciences Authority (HSA) in Singapore, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, and Swissmedic in Switzerland.
Pharma To Market Support
- Supported the TGA and HSA submissions and prepared Module 1 documentation
- Provided Marketing Authorisation Holder (MAH) services in Australia and Singapore
- Contributed local regulatory expertise to support coordinated market access across the consortium
Review Process
The expression of interest was submitted in July 2024. Although the review was initially divided among TGA, MHRA, and Swissmedic, MHRA ultimately completed the full review.
Outcome
Approved indications were consistent across the United Kingdom, Switzerland and Singapore. In Australia, the TGA required a narrower indication. Approvals were granted as follows:
- MHRA — Q3 2025
- Swissmedic — Q3 2025
- TGA — Q4 2025
- HSA — Q4 2025
Overall Benefits
- Shorter evaluation timeframes compared with standard pathways
- Fewer questions, resulting in a significant reduction in regulatory burden for both the client and the health authorities
- A coordinated regulatory process that enabled approvals across four markets within a closely aligned timeframe
Requirements for Success
- Local regulatory expertise in each Access market
- A local entity in each Access market able to act as MAH
Within regulanet®, several partners collaborate to support the Access process:
- regenold UK & Ireland — United Kingdom
- Medius — Switzerland
- Pharma To Market — Australia and Singapore
- Intertek — Canada
Working with us together can support the successful licensing of your product across five key strategic markets in one succinct process.
Conclusion
The Access Consortium represents a structured, long-standing effort by five like-minded regulatory authorities to collaborate across borders in the regulation of medicines. Through shared principles, formal worksharing pathways and coordinated engagement with industry, the consortium seeks to strengthen regulatory efficiency, support innovation, and accelerate patient access to high-quality health products, while preserving national regulatory responsibilities.
As regulatory systems worldwide look for ways to support innovation without increasing burden, the Access Consortium offers a compelling model: collaboration over duplication, reliance over repetition, and alignment in service of patients.
For companies planning international development and submission strategies, understanding Access is becoming increasingly important. While the Access Consortium creates an opportunity to streamline regulatory review, successfully navigating the process still requires expertise across multiple jurisdictions.
Through the regulanet® network, trusted regulatory partners combine local expertise with centralised project management to guide clients through every stage of the Access submission process. By delivering a coordinated regulatory strategy across participating markets, the network helps reduce complexity, improve efficiency, and support timely access to pharmaceuticals for patients around the world.
Move Forward with Clarity and Confidence
Get in touch to find out how regenold and the regulanet® network can accelerate your access to multiple markets.
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