The Need to Advance Global Convergence andRegulatory Reliance to Accelerate Access to Medical Technology
Executive Summary
The medical technology industry supports a strong regulatory system that ensures the safety andeffectiveness of devices and promotes patients’ timely access to medical technologies. Regulations
should be clear, consistent, least burdensome, foster efficiency and support innovation and beconvergent to international best practices and standards. Implementing global convergence andregulatory reliance as a way of advancing “smart regulation” will:•••

Conserve and optimize the use of limited regulatory resources, elevate regulation to one
high standard and accelerate access to safe, high-quality, effective, and innovative medical
technologies to benefit patients, caregivers, and healthcare providers.
Facilitate an environment conducive to the growth of the medical technology sector,
enhancing innovation and providing knowledge-based jobs.
Enhance global health equity through the acceleration of global access to safe, effective
and innovative medical technologies.

To achieve this, GMTA outlines core tenets it recommends, and its members commit to carrying
through to each jurisdiction.
Regulatory convergence and reliance advance smart regulation and underpin an efficient,resilient, and sustainable regulatory framework. GMTA recommends the implementation of
globally convergent medical device regulation, reliance pathways, and the core tenets
outlined below.
I.

Implement convergent regulatory frameworks based on internationally recognized
best practices and standards. Globally convergent regulation brings us closer to one
transparent, predictable, and trusted standard, no matter the jurisdiction – thereby
expediting access to safe and effective medical technologies.

II.

Implement regulatory reliance, including recognition. The adoption of regulatory
reliance, including recognition, is a powerful tool to facilitate accelerated access to safeand effective medical devices, by delivering significant efficiencies for economic operatorsand regulatory authorities, enhancing predictable decision-making and accelerating
approvals. Recognition or leveraging Medical Device Single Audit Program (MDSAP)
certificates for the purpose of domestic approvals by both, members of the International
Medical Device Regulators Forum (IMDRF) and other regulators is an example of wherereliance could be applied in practice.

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III.

Implement core tenets of medical device regulations. To further advance a smart
regulatory framework, these tenets should include ensuring predictability and adequate
resources, applying equal regulation to both domestic and global companies, adopting
Good Regulatory Practices, harmonizing labeling requirements and adopting electroniclabeling, avoiding requirements that lack patient safety benefit, accepting global clinicalinvestigation data and leveraging real world evidence (RWE), implementing a risk-based
approach to product changes, avoiding unnecessary barriers to access based on product’s
country of origin, and implementing a single dossier approach for pre-market review.

GMTA encourages all regulators to implement the foundational principles and core tenets
outlined in this paper to benefit patients, promote public health and enable a robust andsustainable medical technology ecosystem in their home market and globally. GMTA also
encourages all regulators to collaborate with each other and stakeholders to develop globally
efficient, sustainable, and effective regulatory systems.

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Introduction
The medical technology industry supports a strong regulatory system that ensures the safety andeffectiveness of devices1 and promotes patients’ timely access to life-saving and life-enhancing
medical technologies. Regulations should be clear, consistent, least burdensome, foster
efficiency and support innovation, and be convergent to international best practices andstandards. Implementing global convergence and regulatory reliance as a way of advancing“smart regulation” will:•

Conserve and optimize the use of limited regulatory2 resources, elevate regulation to
one high standard and accelerate access to safe, high-quality, effective, and innovative
medical technologies to benefit patients, caregivers, and healthcare providers.

•

Facilitate an environment conducive to the growth of the medical technology sector,
enhancing innovation and providing knowledge-based jobs.

•

Enhance global health equity through the acceleration of global access to safe, effective
and innovative medical technologies.

To achieve this, GMTA outlines core tenets it recommends, and its members commit tocarrying through to each jurisdiction.
Regulatory convergence and reliance advance smart regulation and underpin an
efficient, resilient, and sustainable regulatory framework. GMTA recommends theimplementation of globally convergent medical device regulation, reliance pathways, andthe core tenets of medical device regulations.

Foundational Principles and Core Tenets
I.

Implement convergent regulatory frameworks based on internationally recognized
best practices and standards.

Regulatory convergence is a form of cooperation and collaboration between regulatory
authorities and represents a voluntary process whereby the regulatory requirements andapproaches across countries and regions become more similar or aligned over time as a result of
the adoption of the same technical documents, standards and scientific principles(harmonization) and similar regulatory practices and procedures3.

1

For the purpose of this paper, the term “device” is intended to include both medical devices and in vitro diagnostics.

2 For the purpose of this paper, when the term “regulator” is used, it is intended to include recognized institutions such as the World HealthOrganization.
3

http://www.imdrf.org/docs/imdrf/final/procedural/imdrf-proc-180727-terms-of-reference.pdf

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“The future of medical products regulation is in convergence/ harmonization, collaboration,and networking based on reliance and trust.”4 Globally convergent regulation brings us closer
to one transparent, predictable and trusted standard, no matter the jurisdiction – thereby
expediting access to safe and effective medical technologies.
In contrast, jurisdiction-specific requirements that depart from global best practice and standards
create varying levels of regulation, build varying levels of product quality and safety, and slow
patient access to innovations that transform healthcare through earlier disease detection, lessinvasive procedures, and more efficient treatments. Divergent regulations also create
unnecessary market entry hurdles, reduce export opportunities, and result in non-tariff barriers.
These regulatory hurdles can also impede international trade, hinder market access and growth,and increase costs.
Examples of jurisdiction-specific requirements that hinder access include unique registration
requirements, in-country clinical trials, in-country lot testing, country-specific labelingrequirements and prior approval in the country of origin and/or country of manufacturer. Other
examples include re-registration requirements5 and redundant inspections. These regulations
create unnecessary complexity, are unreasonably burdensome, and sometimes discriminatory dejure and/or de facto against foreign firms. Such laws and regulations are especially burdensome
for small and medium-sized enterprises (SMEs). In the medical technology industry, SMEs
account for much of the industry’s innovation.
Regulatory authorities, global health organizations, and industry have pursued regulatory
convergence through international initiatives for many years to enhance regulatory capacity andefficiency and expedite patient access. These efforts towards regulatory convergence – whether
through the International Medical Device Regulators Forum (IMDRF), the WHO, or others,remain highly important. Similar medical technology regulatory convergence work is taking
place in the Global Harmonization Working Party (GHWP) and the Pan-American HealthOrganization (PAHO). GMTA recommends the various organizations driving global
convergence activities align efforts with each other. Doing so will strengthen efforts andensure regulations evolve into one globally recognized best practice.
At the center of global regulatory convergence is IMDRF. The IMDRF has a long history of
establishing international best practices that optimize medical device regulatory frameworks.
IMDRF’s roots began in 1992 as the Global Harmonization Task Force (GHTF) when regulatorsand supply companies from the USA, Canada, Australia, Japan and Europe came together toenhance patient safety and increase access to safe, effective, and clinically beneficial medical
technologies.
4

Azatyan, S., MD, PhD (2020, November 3). WHO Activities: focus on reliance [Conference Presentation], 10th Asia Regulatory Conference.
https://arc.ifpma.org/wp-content/uploads/2016/05/ARC_2020_S.Azatyan-WHO-01-11-2020.pdf, page 16.
Accessed July 13, 2021.
5 Re registration refers to the practice of requiring manufacturers to re-apply for registration of legally markets products on a periodic basis(e.g., 3, 5 or 10 years).

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The WHO, in their Global Model Regulatory Framework, also references several GHTF
documents as best practice. This is a testament to the quality of work and thought that went into
the GHTF documents. Generally, GHTF documents use a risk-based approach and areunderpinned by internationally recognized standards (e.g., ISO 13485 and IEC).
Building on this success, GHTF was replaced by the International Medical Device Regulatory
Forum (“IMDRF”) in October 2011. IMDRF is a voluntary group of medical device regulatorsfrom around the world who have come together to build on the strong foundational work of the
GHTF, accelerate international medical device regulatory convergence and advanceharmonization based on international standards. Through its diverse members, ideal practices
build on GHTF documents and emerge in IMDRF Guidance.6 IMDRF continues to elevate its
convergence efforts. In 2022, IMDRF created an Affiliate membership option that broadenscountry participation in IMDRF and exposure to its best practices.
Implementation of internationally recognized standards is also key because standards are used
to demonstrate a device meets the essential requirements for safety and performance.
II.

Implement Regulatory Reliance, including recognition.

GMTA supports the inclusion of reliance principles as part of all medical device regulatory
frameworks. The WHO defines regulatory reliance, which includes ‘recognition,’ as “The act
whereby the regulatory authority in one jurisdiction takes into account and gives significant
weight to assessments performed by another regulatory authority or trusted institution, or toany other authoritative information, in reaching its own decision. The relying authority
remains independent, responsible and accountable for the decisions taken, even when it relieson the decisions, assessments and information of others.”7 Today, factors such as
globalization, rapidly advancing health technologies, international supply chains, evolutions inregulatory science and global pandemics have increased the focus and urgency for regulatory
reliance to enhance regulatory capacity and efficiency worldwide. Organizations like the WHO
increasingly see it as an integral part of regulatory operations. GMTA is aligned with the WHO’s
assessment that “reliance represents a ‘smarter’ form of regulatory oversight” and “a decision
to ‘regulate through reliance’ is the hallmark of a modern and efficient regulatory
authority.”8 In addition, GMTA also recommends the WHO practice recognition9 on thedecisions for stringent regulators (e.g., IMDRF Management Committee members). Doing so
will avoid redundant performance evaluations, review of product changes, and inspections.
Regulatory reliance is a powerful tool to facilitate accelerated access in any market, butparticularly in emerging markets with limited regulatory resources or a public health emergency.
Benefits of reliance include:6

For a list of current IMDRF members visit: https://www.imdrf.org/about

7

The WHO Expert Committee on Specifications for Pharmaceutical Preparation, the fifty-fifth report, 2021, page 243.

8

Id, page 256.

9

Recognition is a subset of reliance and is the full acceptance of the regulatory decision of another regulator or trusted institution. Id, 243.

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•
•
•
•
•

Ensure faster patient access to safe, effective, and quality-assured devices.
Deliver significant efficiencies for regulatory authorities and the WHO.
Enable resilient health system preparedness and response (particularly during publichealth emergencies).
Enhance the predictability of decision-making and streamline approvals,10 productchanges and inspections.
Promote broad adoption of innovative technologies and reduce unnecessary complexity
and burden.

Regulatory reliance provides an opportunity to avoid duplication, improve resource
allocation/utilization and enhance efficiency of regulatory processes by focusing onfunctions that must be performed locally (e.g., vigilance and market surveillance) while
informing other work (e.g., safety and effectiveness assessment) by looking to other trusted
references, regulatory authorities, and/or by sharing regulatory workload and responsibility
through cooperation. As many regulators recognized during the COVID-19 pandemic,
regulatory reliance practices have increased value during public health emergencies as thosepractices expedite access to needed technologies to counter the emergency.
While GMTA encourages all regulators to adopt reliance models that include recognition ofdecisions by other trusted authorities or institutions, (e.g., MDSAP or marketing
authorization), GMTA recognizes that regulators can benefit from both formal and informal
work-sharing arrangements. The reliant regulatory authority will have to establish confidence
in the counterpart authority and reach agreement on the exchange of confidential information.
Such arrangements enable regulators to concurrently evaluate a premarket submission and rely
on a single decision, which reduces some of the strain on an individual regulator’s resources.
In addition, such work-sharing arrangements can provide a centralized and efficient manner
for manufacturers to submit a single, common application to multiple jurisdictions. This
reduces resource burden while facilitating faster patient access to crucial medical technology.
Finally, work-sharing can also build regulatory capacity through a gained understanding ofreview practices, tools, and decision-making. To achieve the best results, regulators areencouraged to develop a single dossier in collaboration with each other and a process wheremultiple jurisdictions can rely upon that single dossier.
GMTA encourages regulators to expand reliance principles beyond premarket assessments. For
example, reliance is an important principle to remove duplicative post market inspections andreduce needed product change reviews. Post market reliance will ensure that manufacturers
continue to develop and produce high-quality, safe and effective devices while reducing patient
access delays. We encourage reliance on recently performed inspections by trusted partners,e.g., MDSAP-recognized auditing organizations. The MDSAP provides a good example of suchan inspection reliance program, in which the MDSAP member countries, official Observers andAffiliate members accept MDSAP inspections in lieu of local inspections. Non-MDSAP
members also benefit from relying on MDSAP inspections in lieu of performing a local
10

For the purpose of this document the term “approval” is intended to represent the process whereby a regulator (or WHO) reviews the
product information before it can be legally marketed. Different terms are used for this process internationally (e.g., approval, clearance,
registration, market approval).

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inspection through unilateral reliance11. By leveraging MDSAP audits as a replacement or
supplement for local audits or a replacement for additional on-site audits, a more optimal use ofresources would be granted, fostering of a common understanding of safety and effectiveness.
For more information on reliance, please refer to Appendix A.
III.

Implement core tenants of medical device regulation

GMTA sees convergence to internationally recognized best practices and standards, as well as
reliance on foundational principles each jurisdiction should strive for. In addition to convergenceand reliance, GMTA recommends the following approaches to key parts of the total productlifecycle:
1. Ensure predictability and adequate resources. Predictability and timeliness are essential
when advancing an ideal regulatory framework. Therefore, GMTA recommends regulators
commit to specific timelines for reviewing and approving medical technologies. This
commitment ensures greater predictability for economic operators and health authority inthe approval process to help ensure timely patient access – an especially important provision
for devices with an average life cycle of 18 months. Further, to achieve commitments,
GMTA recommends countries commit the resources commensurate with their regulatory
framework. For example, if a country is going to require a premarket conformity assessmentthat includes an examination of a technical dossier and a premarket inspection, that country
must have in place the number of qualified resources necessary to implement therequirements and meet its timeline commitments for all applications that may be submitted.
For countries with fewer resources, implementing reliance and the foundational principles
listed in this document can elevate the developing regulatory framework and accelerateaccess to safe and effective medical devices while minimizing the resource burden.
2. Support innovation and apply equal regulation to both domestic and international
companies. To drive innovation, build economies, and ensure timely access, GMTA
recommends jurisdictions apply regulation and non-discrimination equally to both domestic
and international manufacturers and ensure that regulation can be administered in the sameway.
3. Adopt Good Regulatory Practices. Good Regulatory Practices (“GRP”) help ensurepredictability, transparency, and uninterrupted access to innovative medical technologies.
GRP includes impact assessment and sufficient opportunity and time for the public tocomment on a draft regulation (at least 60 days recommended) as well as sufficient time
to implement changed regulations (for significant updates, it can take five or more years
and sometimes longer for industry to comply with new requirements). This approach helps
ensure regulations converge to global best practices and allows sufficient time to adjust toaccommodate new regulatory requirements. Lastly, adopting GRP also helps avoid
technical barriers to trade because it ensures adequate stakeholder participation andprocess, including, at times, a cost assessment before updating or implementing the new
11

Reliance and recognition may be unilateral, for example, when a country chooses to rely on or formally recognize an assessment fromanother country unilaterally and without reciprocity. The WHO Expert Committee on Specifications for Pharmaceutical Preparation, page 246.

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regulation.
4. Avoid requirements that lack a patient safety benefit. For example, once a product isapproved, countries should avoid imposing country-specific labeling requirements that are
not essential for the safe use of the device, and instead, should country-specific information
be required, accept that this is supplied electronically/via digital labels. In addition,
countries should also avoid imposing periodic re-registration or reassessment requirements
and allow approved products to remain on the market unless approval is explicitly
withdrawn or if the product is recalled temporarily because of deficiencies. This practice
is consistent with well-established regulators and leverages post market inspections,surveillance, and the established Quality System to ensure the manufacturer remains incontrol of the process and materials used to manufacture the product and that the device
continues to comply with what was originally approved. A second example is lot testing.
Lot testing is not recognized as a best practice because it requires enormous regulatory
resources and does little to ensure product safety.
5. Accept global clinical trial data and leverage Real World Evidence12 (“RWE”). Whenrequired, regulators should accept clinical evidence collected and used for regulatory
approval in other countries to meet their own regulatory requirements as long as theclinical data are collected in accordance with ethical standards and Good Clinical
Practices, including those of international standard ISO 14155. Such a provision would
have to be carefully crafted to allow countries to require domestic clinical trials when there
are demographic differences supported by objective scientific evidence that affect safety
and performance. However, some countries continue to require domestic clinical trials. In
some cases, such requirements are carried over from the drugs sector, which is sometimes
justifiable on the grounds of metabolic or genetic differences in populations. Suchconsiderations rarely apply to medical devices.
RWE has emerged as an important data source to supplement regulatory decision-making
through the total product lifecycle. GMTA encourages regulators to implement regulationthat supports the acceptance of RWE.
6. Implement a risk-based approach to product changes. Another important aspect of an
ideal regulatory framework is the management of product changes. Only those changes
significantly affecting the safety or performance of higher-risk devices should require
regulatory review. Not all changes affect a device’s safety or performance. For example,
depending on the device, changes can occur to raw material suppliers, manufacturing,
testing processes, and labeling without affecting the device itself. Additionally, innovativetechnologies, such as software, may necessitate a more rapid change to avoid patient safety
risks (e.g., cybersecurity vulnerabilities). Mandating the review of changes that do notsignificantly affect safety or performance can slow innovation, unnecessarily interrupt the
global supply chain, or drain regulator resources. For these reasons, device changes that
12

FDA defines RWE as “clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis ofRWD.” Real-World Data (RWD) are data relating to patient health status and/or the delivery of healthcare routinely collected from a variety ofsources. See U.S. Food and Drug Administration. Use of Real-World Evidence to Support Regulatory Decision Making for Medical Devices:
Guidance for Industry and Food and Drug Administration Staff. August 2017. Accessed August 20, 2020

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do not significantly affect the safety or performance of a device should not require priorregulatory review. Furthermore, for those device changes that would require priorregulatory review, harmonization of efficient regulatory mechanisms to facilitate more
rapid changes of devices will further patient access to these important changes. For
example, predetermined change control plans provide manufacturers with the option tosubmit a plan to the regulator for specific postmarket changes during initial premarket
review so that these changes can be made rapidly postmarket without additional regulator
review. In addition, reliance on other regulators’ evaluation of product changes would be
an excellent use of reliance practices.
7. Avoid unnecessary barriers to access based on product country of origin. Regulatorswith pre-market approval frameworks in place should not require prior approval in the
manufacturer’s home country or the country of manufacture before seeking, or as acondition of, approval in the domestic market. Such practices are burdensome and delay
patients’ access to medical technologies.
8. Implement a single dossier. GMTA encourages regulators to develop a single dossier
approach according to which results of the single pre-market review can be leveraged for
improved patient access to medical devices in multiple jurisdictions, without the need for
multiple reviews. Such an approach will further facilitate good reliance practices andstrengthen the confidence and consistency in the regulatory decision-making process. Industry
welcomes the initiatives of several regulators launching programs to streamline the review
and approval process for medical devices (e.g., the eSTAR program between the U.S. FDA
and Health Canada; the reliance project between Singapore and Thailand) and would be readyto contribute to the development of a Medical Device Single Review Program (MDSRP) -notlimited to IMDRF members only.
9. Adopt electronic instructions for use. Electronic instructions for use (IFU) can benefit
patients, physicians, caregivers, and manufacturers, by increasing the availability, utility,interactivity, and accessibility of IFU. In addition, supplying electronic IFU may haveenvironmental benefits, including reduced ethylene oxide emissions, reduced paper usage,
and a reduced carbon footprint. It should be noted that in all cases, users would have accessto all of the relevant information. Users who do not have access to electronic copy users canrequest a paper version. The case for electronic IFU is particularly salient when the IFU
relates to a software-based product or the software features of a device when the user of thedevice has access to online information.
10. Embrace digital labels. Current labeling regulations differ across countries and create
significant logistical challenges, especially during device shortages. As a result, devices canonly be used in their intended market due to localized labeling requirements. In addition toelectronic IFUs, digital labels can provide additional information beyond what is printed on
the device. Industry agrees that core information on the identification of a device andhandling are needed, nevertheless we encourage a regulatory framework to enable additional
information, especially information from country-specific regulations, to be made available
to users via a digital label. Adoption of digital labels can improve the user experience.

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Additionally, digital labels allow manufacturers to reduce the need for printing andpackaging, leading to environmental benefit.

Summary
GMTA encourages all regulators to implement the foundational principles and core tenets
outlined in this paper to benefit patients, promote public health and enable a robust andsustainable medical technology ecosystem in their home market and globally. GMTA also
encourages all regulators to collaborate with each other and stakeholders to develop a globally
efficient, sustainable, and effective regulatory system.
As recognized by the WHO, “industry plays a crucial role in the successful application of reliancemechanisms by National Regulatory Authorities”13. It is with this spirit in mind that the medical
technology industry supports a strong regulatory system that ensures the safety and effectivenessof devices and promotes patients’ timely access to medical technologies.

13

WHO QAS/20.851/Rev.1:
https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS20_851_Rev_1_Good_Reliance_Practices.pdf?ua=1

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Appendix A. Benefits of Regulatory RelianceReliance is a strategy for efficiently utilizing resources, building regulatory expertise andcapacity, and elevating access to safe and effective, quality-assured medical products, no matterthe countries’ regulatory maturity. Overall, reliance signifies a smart way to regulate in themodern environment.
The World Health Organization (“WHO”) defines reliance as “The act whereby the regulatory
authority in one jurisdiction takes into account and gives significant weight to assessments
performed by another regulatory authority or trusted institution, or to any other authoritative
information, in reaching its own decision. The relying authority remains independent,
responsible and accountable for the decisions taken, even when it relies on the decisions,assessments and information of others.” 14 While not necessary to implement reliance,
convergence facilitates the reliance process.15 Regulatory convergence is often a gradualprocess that requires long-term engagement across countries with differing legal and regulatory
frameworks as well as health systems and health needs.
Today, factors such as globalization, rapidly advancing health technologies, international
supply chains, evolutions in regulatory science and global pandemics have increased the focus
and urgency for reliance to enhance regulatory capacity and efficiency around the world.
Organizations like the WHO increasingly see it as an integral part of regulatory operations. We
are aligned with the WHO’s assessment that “reliance represents a ‘smarter’ form of regulatory
oversight” and “a decision to ‘regulate through reliance’ is the hallmark of a modern andefficient regulatory authority.”16
Regulatory reliance provides an opportunity to avoid duplication, improve resource
allocation/utilization and enhance the efficiency of regulatory processes by focusing onfunctions that must be performed locally (e.g., vigilance and market surveillance) while
informing other work (e.g., safety and effectiveness assessment) by looking to other trusted
reference regulatory authorities and/or by sharing regulatory workload and responsibility
through cooperation. As many regulators recognized during the COVID-19 pandemic,
regulatory reliance practices have increased value during public health emergencies as thosepractices expedite access to needed technologies to counter the emergency.
Regulatory reliance can be a powerful tool to facilitate accelerated access in any market, andparticularly in emerging markets. The benefits of reliance include:
•
•
•

14

Ensure faster patient access to safe, effective, and quality-assured devices.
Deliver significant efficiencies for regulatory authorities and the WHO.
Enable resilient health system preparedness and response (particularly during publichealth emergencies).

The WHO Expert Committee on Specifications for Pharmaceutical Preparation, page 243.

15 The WHO has made clear that “[d]ifferences in standards and practices do not prevent one authority from relying on another, particularly

when the relying authority has limited capacity and expertise.” Good Reliance Practices in the Regulation of Medical Products, Annex 10, page255.
16 The WHO Expert Committee on Specifications for Pharmaceutical Preparation, page 256.

Page 11 of 13••Enhance the predictability of decision-making and streamline approvals,17 productchanges and inspections.
Promote broad adoption of innovative technologies and reduce unnecessary
complexity and burden.

Regulatory reliance also has the potential to improve health globally. In today’s complex
economy, disease and illness are no longer contained within boarders. Our global healthdepends on the success of regulators around the world to ensure continued timely access todevices. In addition, by reducing the time lag between device availability in the wealthiest
and less wealthy countries, effective use of reliance has the potential to enhance global
health equity. Lastly, in time-sensitive situations, such as a pandemic or health emergency,
reliance supports timely and effective responses at global, regional, and national levels –thus helping to insulate our global protection from rapidly spreading diseases. While there
may be differences in national standards and practices, this does not impede the effective
use of reliance. The WHO made it clear that, reliance is an effective pathway, even if
standards and practices between jurisdictions differ.18
GMTA supports regulatory reliance as a timely and efficient way to increase access to safe,
high-quality, effective, and innovative healthcare products that benefit patients. GMTA also
believes accountability, strategic investment, and scope as well as transparency andinformation sharing are critical requirements and considerations to implement a successful
reliance framework.
Accountability, Strategic Investment and Scope
Each national regulatory authority must retain independence, sovereignty and accountability
for decision-making. Utilizing reliance does not sacrifice autonomy of responsibility andaccountability. Sharing of scientific, clinical or technical information, or regulatory
assessments and rationales, should be supported by confidentiality agreements between
regulators and limited to only that data necessary to reach a decision.
All relevant stakeholders, including industry, should be informed and engaged during thedevelopment and implementation of reliance approaches and frameworks. Industry may be
best placed to identify new areas that will benefit from reliance approaches. This offers theopportunity to provide feedback on the progress of international/regional/national efforts andto deliver valuable input based on direct experience of using new systems. Reliance systems
must incorporate a framework for consulting with key stakeholders as policy is developed andensure realistic timelines for transition to new requirements for both regulators and industry.

17

For the purpose of this document the term “approval” is intended to represent the process whereby a regulator (or WHO) reviews the
product information before it can be legally marketed. Different terms are used for this process internationally (e.g., approval, clearance,
registration, market approval).
18
Good Reliance Practices in the Regulation of Medical Products, page 255.

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Transparency and Information Sharing
The choice of the reference regulatory authority for reliance purposes and the criteria usedshould be transparent. We support the World Health Organization’s (“WHO”) effort toestablish and implement a framework for evaluating and designating national regulatory
authorities (“NRAs”) that meet a defined criterion. GMTA believes a trusted authority or
institution is one that is well-resourced, competent and efficient in their performance of healthregulation based on Good Regulatory Practices and internationally recognized standards toensure human health and safety.
Reliance, as well as joint evaluation and collaborative reviews, are enabled by effective
information sharing, convergence, and the harmonization of regulatory standards andguidelines. Reliance procedures and decisions should be available and shared between
regulators whilst ensuring appropriate safeguards and consent systems to protect personal dataand confidential commercial information. Reliance approaches must be based upon highquality, evidence-based assessments and implemented consistently. Decision-making
processes must be transparent, enhancing public understanding of how decisions are made bya relied upon authority, as well as how decisions are made by the relying authority.

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