EMA OPEN Framework 2026 Update: What Pharma and Regulatory Affairs Teams Need to Know

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The EMA OPEN framework (Opening Procedures at EMA to Non-EU Authorities) allows the European Medicines Agency (EMA) to run near-concurrent scientific assessments of certain medicines alongside seven non-EU regulatory partners, while each authority keeps full independence over its own decision. Originally piloted for COVID-19 medicines in December 2020, it was expanded to a wider range of therapeutic areas on 20 July 2023 and remains the operational basis for cross-border collaboration today. In January 2026, EMA updated its official Questions and Answers (Q&A) guidance on OPEN, clarifying submission timing, expert participation and opt-out rules. This matters for sponsors, marketing authorisation holders and regulatory affairs professionals building global submission strategies.

EMA OPEN framework — parallel scientific evaluation between European and international medicines regulators

1. At a Glance

2. Background: Why Parallel Regulatory Review Became Necessary

3. What Is the OPEN Framework and Who Are Its Partners?

4. Which Medicines Are Eligible, and How Does the Process Work?

5. The January 2026 Q&A Update and What It Clarifies

6. How OPEN Fits Into the EU Pharmaceutical Legislation Reform

7. Deepen Your Knowledge: Regulatory Affairs Training on This Topic

8. Practical Implications for Regulatory Affairs Professionals

9. Key Takeaways

10. Take the Next Step in Your Regulatory Affairs Career

11. Frequently Asked Questions

12. Further Reading and Reference Sources

AT A GLANCE

- OPEN stands for Opening Procedures at EMA to Non-EU Authorities — a framework enabling near-concurrent, independent scientific review of certain medicines by EMA and non-EU regulators.

- OPEN began as a COVID-19 pilot in December 2020 and was formally expanded to a wider range of medicines on 20 July 2023.

- Seven partners currently participate: TGA (Australia), ANVISA (Brazil), Health Canada, PMDA (Japan), MFDS (South Korea), Swissmedic, and the World Health Organization (WHO).

- Eligible medicines include those targeting antimicrobial resistance (AMR), PRIME-designated products, medicines addressing a high unmet medical need, and products responding to public health threats or emergencies, including vaccines.

- EMA updated its official Questions and Answers on the 'OPEN' Framework document (Reference EMA/55338/2023) on 20 January 2026, the most recent formal clarification of the process.

- Applicants must submit to EMA and at least one OPEN partner within one month of each other, with harmonised dossier content across jurisdictions.

- OPEN does not override national sovereignty: every OPEN partner retains full independence in its own regulatory decision.

BACKGROUND: Why Parallel Regulatory Review Became Necessary

Global drug development has outpaced the traditional model of sequential, jurisdiction-by-jurisdiction regulatory review. When a company develops a genuinely novel medicine — particularly one addressing antimicrobial resistance (AMR), a rare hereditary disease, or a public health emergency — waiting for each national or regional authority to complete an independent review in isolation creates delays that matter clinically, not just commercially. The European Medicines Agency (EMA) is the centralised body responsible for the scientific evaluation of medicines seeking authorisation across the European Union, working through its Committee for Medicinal Products for Human Use (CHMP). Regulators worldwide have increasingly recognised that duplicated effort on the same clinical data package serves no one — not the regulator, not the sponsor, and least of all the patient waiting for access. This is the gap the OPEN framework was built to close: a structured mechanism for regulators to review the same evidence in parallel, sharing expertise without surrendering independence.

Interested in building a career working with international regulatory frameworks like the EMA's OPEN framework and cross-border marketing authorisation strategy? The Introduction to Regulatory Affairs course at Entry to Regulatory covers EU, UK and US submission pathways, Common Technical Document (CTD) structure, and post-authorisation procedures, giving you the practical knowledge, real work experience and job search support to break into or advance within regulatory affairs. - 50+ CPD-accredited hours of expert-led training - Up to 3 months of real regulatory work experience - Mentoring and job search support until you are employed - Covers EU, UK and US pharmaceutical regulations - Taught by a regulatory affairs expert with 10+ years at MHRA, GSK, MSD and Bayer - Study online, part-time, just 6 hours per week View the course and start with a free introductory webinar: https://pages.entrytoregulatory.com/courses/

The mechanism did not appear fully formed. It emerged directly from the COVID-19 pandemic, when EMA and its counterparts abroad were reviewing the same vaccines and therapeutics simultaneously, often against the same clinical datasets, under enormous time pressure. That experience — launched as a pilot in December 2020 — proved that parallel review was operationally workable and scientifically sound, without compromising any regulator's independence. Following a positive review of that pilot's first year, EMA formally extended OPEN beyond COVID-19 medicines on 20 July 2023, turning what began as an emergency measure into a permanent feature of the EU's international regulatory toolkit. Understanding how that evolution occurred — and where it is heading next — is a core component of the Entry to Regulatory training programme, which covers international submission strategy and post-authorisation procedures as part of its practical EU, UK and US curriculum — see the full course details at https://pages.entrytoregulatory.com/courses/

Timeline of the EMA OPEN framework from COVID-19 pilot to 2026 expansion

What Is the OPEN Framework and Who Are Its Partners?

OPEN — Opening Procedures at EMA to Non-EU Authorities — is a formal collaborative arrangement that allows the European Medicines Agency (EMA) to conduct near-concurrent scientific evaluations of certain medicines alongside regulatory counterparts outside the EU, referred to as OPEN partners. Each partner conducts its own assessment in parallel to the EMA's, sharing scientific expertise and comments while remaining fully independent in its final decision. According to EMA's official OPEN framework page, seven partners currently participate under permanent confidentiality arrangements:

OPEN Partner	Jurisdiction
Therapeutic Goods Administration (TGA)	Australia
Brazilian Health Regulatory Agency (ANVISA)	Brazil
Health Canada (HC)	Canada
Pharmaceuticals and Medical Devices Agency (PMDA)	Japan
Ministry of Food and Drug Safety (MFDS)	Republic of Korea
Swiss Agency for Therapeutic Products (Swissmedic)	Switzerland
World Health Organization (WHO)	International

Experts nominated by these authorities — known as OPEN experts — are invited to attend and comment during CHMP, Committee for Advanced Therapies (CAT), and Emergency Task Force (ETF) meetings where relevant. They are subject to the same declaration-of-interest and confidentiality requirements as any EU committee member, and critically, they are not permitted to contribute to the Committee's final conclusions or vote on the adoption of opinions — they participate in the scientific discussion, not the ultimate decision.

Which Medicines Are Eligible, and How Does the Process Work?

Following the 20 July 2023 expansion, OPEN's scope moved well beyond its COVID-19 origins. Per EMA's current guidance, medicines are eligible for OPEN assessment if they fall into one of four categories:

1. Treatments and novel antimicrobials addressing antimicrobial resistance (AMR)

2. Medicines designated under the PRIME scheme (EMA's early development support pathway for products addressing unmet needs)

3. Medicines that address another form of high unmet medical need

4. Medicines, including vaccines, responding to public health threats or public health emergencies

The framework applies to Marketing Authorisation Applications (MAAs) as well as post-authorisation procedures, including extensions of marketing authorisations, Extensions of Indication (EoI), and quality variations. To be included, applicants must submit their application to EMA and to at least one OPEN partner within one month of each other, specifying their request via a "Letter of Intent" through the EMA service desk. Crucially, the dossier content and proposed indication must be harmonised across all participating jurisdictions — meaning regulatory teams need to design a single, coherent global data package rather than adapting a EU-only submission after the fact. Regulatory professionals looking to deepen their understanding of harmonised international submission strategy will find relevant practical training in the Entry to Regulatory course, which includes hands-on assignments covering CTD structure and multi-jurisdictional dossier planning as part of its EU, UK and US regulatory curriculum. Full details at https://pages.entrytoregulatory.com/courses/

The January 2026 Q&A Update and What It Clarifies

The most recent formal development is EMA's update to its Questions and Answers on the 'OPEN' Framework document (Reference EMA/55338/2023), refreshed on 20 January 2026. This is the operational guidance document EMA points applicants toward directly, and it consolidates practical detail that regulatory teams previously had to infer from individual procedures. Among the clarifications it sets out:

- The number of OPEN experts permitted to attend scientific committee meetings is capped at three per OPEN partner, with limited exceptions for specific expertise needs.

- Assessment reports, lists of questions and interim/final opinions are shared with OPEN partners under confidentiality arrangements, and OPEN partners are expected to reciprocate with their own assessment outputs.

- Applicants may formally withdraw from OPEN once assessment has started, but only via written notice with justification to both EMA and the relevant partners — and the withdrawal must be reflected consistently in how each authority subsequently communicates its decision.

- Where an application cannot be submitted in parallel, reliance pathways remain available, allowing non-EU regulators to draw on EMA's published assessment reports without formal OPEN participation.

Regulatory affairs professional reviewing EMA OPEN framework Q&A guidance documents

How OPEN Fits Into the EU Pharmaceutical Legislation Reform

OPEN does not operate in isolation from the wider direction of EU pharmaceutical policy. On 11 December 2025, EU institutions reached a political agreement on a substantial reform of EU pharmaceutical legislation — described by multiple industry sources, including EMA itself, as the first major overhaul of the framework in over two decades. Reported elements of the reform include a revised market exclusivity model, streamlined marketing authorisation timelines, digital submission modernisation, and dedicated incentives — including a transferable data exclusivity voucher — for priority antimicrobial development. The final legislative texts were expected to be adopted through 2026, with a transition period running to 2028 for member states to align national law. Because AMR is also one of OPEN's core eligibility categories, the reform and the OPEN framework point in the same policy direction: faster, better-coordinated access to medicines that address the most pressing unmet needs. Regulatory teams should treat the two as connected developments rather than parallel, unrelated tracks.

Deepen Your Knowledge: Regulatory Affairs Training on This Topic

Working effectively with frameworks like OPEN requires more than awareness that the mechanism exists. Regulatory affairs professionals need practical fluency in harmonised CTD dossier construction, an understanding of how marketing authorisation applications and post-authorisation variations move through EMA's centralised procedure, and the ability to interpret how EU, UK and US requirements converge and diverge on the same product. These are precisely the skills that separate a generalist from someone genuinely equipped for international regulatory work.

The Introduction to Regulatory Affairs course at Entry to Regulatory is built around this practical gap. Rather than teaching frameworks in the abstract, the course curriculum works through real submission scenarios — building CTD modules, classifying post-authorisation variations, and comparing EU, UK and US regulatory expectations side by side — so that graduates can speak credibly about exactly the kind of cross-border coordination that OPEN represents.

This training is particularly valuable for life science graduates seeking entry-level regulatory roles, scientists and pharmacists making a first move into regulatory affairs, and career changers from adjacent healthcare or clinical backgrounds who already understand drug development but need the regulatory-specific framework to translate that knowledge into a job.

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TRAINING SPOTLIGHT BOX:

Course: Introduction to Regulatory Affairs

Provider: Entry to Regulatory

Relevant to this topic: CTD and eCTD dossier structure, Marketing Authorisation Application (MAA) procedure, post-authorisation variations classification, EU/UK/US regulatory comparison, international submission strategy

Format: Online, part-time | 6 hours per week | 3 months

Includes: Up to 3 months real work experience, job mentoring, CV review, mock interviews, industry-recognised certificate

Suitable for: Life science graduates, pharmacy professionals, career changers, scientists seeking regulatory transition

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Practical Implications for Regulatory Affairs Professionals

The OPEN framework changes how sponsors and regulatory affairs teams should plan submissions, not just how they should read about them. The table below sets out the practical questions professionals are asking as OPEN moves further into mainstream use.

Key Question	Previous Situation	What Changes Now
When should we consider OPEN eligibility?	Often assessed only at submission stage, if at all	Should be assessed as early as scientific advice or PRIME designation stage
How many partner authorities do we need to involve?	Ad hoc, product-by-product decisions	At least one OPEN partner must agree to participate, with harmonised submission timing (≤1 month apart)
Do we need separate dossiers per country?	Country-specific dossier packages built independently	Dossier content and proposed indication must be harmonised across participating jurisdictions
Who reviews the scientific data during assessment?	EMA's CHMP and national experts only	Up to three OPEN experts per partner also comment, though without voting rights
Can we withdraw once assessment starts?	Rarely formalised, ad hoc communication with EMA	A defined withdrawal process now exists, requiring written notice and justification to EMA and partners
What if our product can't be submitted in parallel?	Limited formal alternative	Reliance pathways let non-EU regulators use EMA's published assessment reports without full OPEN participation
How does this affect our regulatory training needs?	Generalist regulatory knowledge often sufficient	Teams increasingly need structured training in international submission strategy and harmonised CTD building

Key Takeaways

1. Assess OPEN eligibility early. If your pipeline includes AMR, PRIME-designated, or high unmet need products, evaluate suitability at the scientific advice stage, not at submission.

2. Build harmonised CTD packages from the start. Designing a single dossier structure that satisfies EMA and your chosen OPEN partner avoids costly rework later.

3. Read the current EMA Q&A document directly. The 20 January 2026 update (EMA/55338/2023) is the primary operational reference — do not rely solely on secondary summaries.

4. Map your OPEN partner's specific requirements. Parallel review does not mean identical standards; know where TGA, Health Canada, PMDA, ANVISA and MFDS diverge from EMA.

5. Plan for the withdrawal process, even if you don't expect to use it. Understand the formal notice requirements before you commit to an OPEN submission.

6. Track the EU pharmaceutical legislation reform in parallel. Its AMR incentives and streamlined timelines will directly shape how OPEN operates once implementation completes by 2028.

7. Invest in structured international regulatory training now. Frameworks like OPEN are evolving faster than most internal knowledge bases — practical, up-to-date training is the sustainable response.

Take the Next Step in Your Regulatory Affairs Career

Frameworks like OPEN are a signal of where the regulatory affairs profession is heading: international coordination, multi-agency fluency, and harmonised global submission strategy are no longer specialist niches — they are becoming standard expectations for regulatory professionals at every level, from entry-level associate through to senior regulatory strategy roles. Understanding how a marketing authorisation application moves through parallel review, and how to build a CTD dossier that satisfies more than one regulator at once, is a genuinely transferable, in-demand skill.

If you are exploring a move into regulatory affairs, or already working in the field and looking to build the international fluency that roles like this increasingly require, the Introduction to Regulatory Affairs course is designed to take you from foundational knowledge to real, practical competence — with actual regulatory work experience built in. A free introductory webinar is available as a low-commitment way to see whether the course is the right fit before enrolling.

Explore the full course details and register for a free introductory webinar at Entry to Regulatory: https://pages.entrytoregulatory.com/courses/

Professional studying regulatory affairs training online — pharmaceutical industry career development

Frequently Asked Questions

What does OPEN stand for in EMA regulatory terms?

OPEN stands for "Opening Procedures at EMA to Non-EU Authorities." It is a collaborative framework enabling near-concurrent, independent scientific evaluation of certain medicines by the EMA and international regulatory partners.

Which medicines are eligible for EMA OPEN assessment?

Medicines targeting antimicrobial resistance, PRIME-designated products, medicines addressing another high unmet medical need, and products responding to public health threats or emergencies, including vaccines — provided EMA's CHMP and at least one OPEN partner agree to participate.

Does OPEN replace national regulatory approval processes?

No. Every OPEN partner retains full scientific and regulatory independence. OPEN facilitates parallel review and information sharing; it does not override or replace any jurisdiction's own authorisation decision.

When was the OPEN framework expanded beyond COVID-19?

EMA formally expanded OPEN to a wider range of medicines on 20 July 2023, following a positive one-year review of the COVID-19 pilot.

How can I build the skills needed to work with frameworks like OPEN?

Structured, practical training is the most reliable route. The Introduction to Regulatory Affairs course at Entry to Regulatory covers CTD dossier structure, marketing authorisation procedures, and EU/UK/US regulatory comparison, giving newcomers and career changers the specific skills that international regulatory work demands. Details are available at https://pages.entrytoregulatory.com/courses/

Speak to us today and find out how we can help you get into Regulatory Affairs.

About the Author: Rabiea is an Honorary Associate Professor at UCL, former MHRA Health Authority reviewer, and CEO of Entry to Regulatory and Advanced Regulatory Consulting. After transitioning from retail pharmacy to regulatory affairs, she has dedicated her career to helping others make the same successful career change. Connect with her on LinkedIn for the latest regulatory affairs insights and career advice.

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