International Combination Products
vii
Foreword
Beat U. Steffen, MSc, MBA
The field of combination products is relatively new
and only a few publications concerning the unique
challenges posed by this emerging but fast-growing
area are available, particularly when it comes to
respective regulatory challenges. It is a significant
area with different regulatory environments in
various geographical regions.
Unfortunately for the industry, there is an
absence of clearly defined global harmonized
regulations. Combination products bring together
regulatory frameworks that are usually distinct from
one another. A structured development process,
using a risk-based approach and a sound quality
system is required. Even though the terminology
may be different in the two areas, a consistent
framework helps bring them together and ensures a
safe and effective use of a combination product.
This continues to be a remarkable time for
regulatory science, very dynamic and changing fre-
quently. However, while translating new discoveries
into the real-world, combination products can make
an enormous difference for individual and popula-
tion health, both in hospitals but also in home-use.
The process is complex and difficult. The painstak-
ing work to develop, verify, validate, and receive
approval of a new combination product requires
a vast range of expertise, skills, and dedication.
Complicating this challenge is the fact that, unlike
drugs and devices by themselves, the degree of
innovation in convergent technologies is a multiple
of the innovation in either area alone. It demands
coordinated work across disciplines, sectors, and,
increasingly across nations. It addresses the tech-
nical, scientific, regulatory, and quality issues that
arise when combining drugs, biologics, and medical
devices into a single product.
Providing an in-depth look at this break-
through field, International Combination Products
includes background information and practical
guidelines regarding regulatory challenges of these
novel technologies. It takes a practical, readily appli-
cable approach to discussing the relevant challenges,
victories, and pitfalls associated with merging
technologies. Specifically, this book explores the
process from start to finish, establishing a workable
regulatory strategy to bring the products to the
market in a compliant and timely manner.
No matter how steeped one is in combination
products and their various regulations in different
geographical areas, this book provides both updated
information and new insights. For those starting
their career in regulatory, this book will serve as a
vital source for knowledge and action.
This comprehensive publication with a wealth
of invaluable information is based on the vast expe-
rience and expertise of Jocelyn Jennings, MS, RAC
(US, Drugs, Devices), a veteran in the combination
product regulatory space. Although regulations are
naturally ever-changing, this book is considered a
landmark in this fascinating space.
Given the array of unmet medical care and
public health needs before us, this is not an aca-
demic exercise. There is a pressing responsibility to
make sure the opportunities in science and tech-
nology today will result in the safe, effective, and
high-quality medical products people so hope for
and deserve. Every effort must be made to ensure
the best possible products are delivered as swiftly
as possible, but never forgetting the scientific rigor
and regulatory oversight that ultimately determine
failure or success.
vii
Foreword
Beat U. Steffen, MSc, MBA
The field of combination products is relatively new
and only a few publications concerning the unique
challenges posed by this emerging but fast-growing
area are available, particularly when it comes to
respective regulatory challenges. It is a significant
area with different regulatory environments in
various geographical regions.
Unfortunately for the industry, there is an
absence of clearly defined global harmonized
regulations. Combination products bring together
regulatory frameworks that are usually distinct from
one another. A structured development process,
using a risk-based approach and a sound quality
system is required. Even though the terminology
may be different in the two areas, a consistent
framework helps bring them together and ensures a
safe and effective use of a combination product.
This continues to be a remarkable time for
regulatory science, very dynamic and changing fre-
quently. However, while translating new discoveries
into the real-world, combination products can make
an enormous difference for individual and popula-
tion health, both in hospitals but also in home-use.
The process is complex and difficult. The painstak-
ing work to develop, verify, validate, and receive
approval of a new combination product requires
a vast range of expertise, skills, and dedication.
Complicating this challenge is the fact that, unlike
drugs and devices by themselves, the degree of
innovation in convergent technologies is a multiple
of the innovation in either area alone. It demands
coordinated work across disciplines, sectors, and,
increasingly across nations. It addresses the tech-
nical, scientific, regulatory, and quality issues that
arise when combining drugs, biologics, and medical
devices into a single product.
Providing an in-depth look at this break-
through field, International Combination Products
includes background information and practical
guidelines regarding regulatory challenges of these
novel technologies. It takes a practical, readily appli-
cable approach to discussing the relevant challenges,
victories, and pitfalls associated with merging
technologies. Specifically, this book explores the
process from start to finish, establishing a workable
regulatory strategy to bring the products to the
market in a compliant and timely manner.
No matter how steeped one is in combination
products and their various regulations in different
geographical areas, this book provides both updated
information and new insights. For those starting
their career in regulatory, this book will serve as a
vital source for knowledge and action.
This comprehensive publication with a wealth
of invaluable information is based on the vast expe-
rience and expertise of Jocelyn Jennings, MS, RAC
(US, Drugs, Devices), a veteran in the combination
product regulatory space. Although regulations are
naturally ever-changing, this book is considered a
landmark in this fascinating space.
Given the array of unmet medical care and
public health needs before us, this is not an aca-
demic exercise. There is a pressing responsibility to
make sure the opportunities in science and tech-
nology today will result in the safe, effective, and
high-quality medical products people so hope for
and deserve. Every effort must be made to ensure
the best possible products are delivered as swiftly
as possible, but never forgetting the scientific rigor
and regulatory oversight that ultimately determine
failure or success.