Welcome to module 1

What is reliance?
By the end of this module, you will be able to:
explain what reliance is
recognize why reliance is so important for the
global regulatory oversight of medical products
Regulatory systems

skilled human resources

financial investment
Regulatory challenges

Regulatory authorities are facing science and regulatory challenges in a rapidly

evolving environment.

globalization of markets sophistication of health technologies

rapid evolution of regulatory science increasing complexity of supply chains

transparency and growing public

lack of global regulatory resources
expectations
Regulatory challenges

Regulatory challenges highlight the need for international cooperation to ensure

the safety, quality and efficacy of locally registered medical products.
Need for collaboration

NRAs must consider enhanced,

innovative, and effective forms of
collaboration to:

make the best use of the available

resources and expertise
avoid duplication where possible
concentrate regulatory efforts and
resources where they are most
needed
Good regulatory practices (GRP)

Countries are encouraged to formulate

and implement strategies to:

strengthen their regulatory systems

be consistent with good regulatory
practices

regulatory cooperation
convergence
reliance
Reliance

Reliance represents a smarter, more efficient way of regulating medical products in

the modern world by using global resources more efficiently.
Reliance

The concept of reliance is central for both:

strengthening regulatory systems activities

increasing the efficiency of the global
regulatory oversight of medical products
WHO good reliance practices (GRelP)

WHO good reliance practices (GRelP) are anchored in overall good regulatory
practices (GRP).
Reliance

Reliance is not a new concept.

Definition of reliance

Reliance is the act whereby one regulatory authority takes into account and gives
significant weight to assessments performed by another regulatory authority, trusted
institution or other authoritative information, in reaching its own decision.
Different types of reliance

Reliance can take many different shapes and forms

adapted to the needs of the NRA.
Principles of reliance

international efficient approach to sovereignty of

cooperation regulatory oversight decision-making
Who does reliance benefit?

Reliance benefits:

patients and consumers

industry
national governments
the donor community
international development partners
Scope of GRelP

Regulatory oversight of medical

products:

medicines
vaccines
blood and blood products
medical devices, including in-vitro
diagnostics
Scope of GRelP

Reliance principles can apply for all regulatory

functions, including:

registration and marketing authorization

vigilance
market surveillance and control
licensing establishments
regulatory inspection
laboratory testing
clinical trials oversight
NRA lot release
Key Point

Reliance is a strategy for making the best use of the available

resources in any setting.
You have now completed Module 1.

In the next module, we will look at the 6

high-level principles of WHO GRelP.