Postapproval Changes for Drugs: A Practical Guide
vii
Foreword
Postapproval changes are a vital part of medicines development and regulatory affairs. These changes reflect
the dynamic and iterative nature of science and how products develop and mature across the lifecycle.
The postapproval phase consumes more resources and costs than the initial development of medicines.
The proportions vary across products and therapeutic fields, but on average, today exceed 65% of the total
research and development spend. Yet this area has received relatively little attention until recently.
RAPS new book, Postapproval Changes for Drugs, is a welcome exception. This practical guide
covers the breadth of issues which encompass postapproval changes, ranging from the important but
more routine matters, such as marketing authorization transfers, administrative changes, late phase
renewals through to additional indications. This book covers these and many more matters from a
comprehensive global perspective by detailing and exploring the differences between the Americas,
Europe, Asia, Middle East and North Africa, and sub-Saharan Africa. The global coverage is important
because despite the great efforts for harmonization through the International Council for Harmonisation
of Technical Requirements for Pharmaceuticals for Human Use (ICH) and in particular, the ICH
Q12 guideline addressing technical and regulatory considerations for pharmaceutical product lifecycle
management, major differences in legislative approach remain.
Section II has authoritative chapters on the handling of quality and chemistry, manufacturing, and
control changes. Here we see the differences in approach from tacit approval, with a do and tell approach
through to strict approach on variation changes in Europe which has still to fully embrace the changes
set out in ICH Q12. This matters because of the impact it has in low- and middle-income countries with
the delays in approving product quality changes and the impact on the supply chain and costs of having
to maintain large inventories of different and older product forms. The chapters highlight the ongoing
attempts to resolve these burdens which are important to both public health and access to medicines.
Section III on safety and product information related changes postlaunch and Section V on
postmarketing surveillance and risk management are very welcome additions since these are rightly
becoming a major focus and an expanding area of postapproval changes.
A key and accelerating global trend is for more conditional approvals with a growing number of
postapproval commitments. It is excellent to see this topic discussed in Section IV of the publication.
When I was president of RAPS we introduced the tagline, “advancing public health through
knowledge and regulatory science.” This publication furthers this objective by giving an authoritative
account of the regulation of postapproval changes across the globe. It is not only a great reference text,
but it should be a wake-up call for introducing further change to this subject, which is so important for
all the stakeholders but above all for patient access to medicines.
David Jefferys, MD
Senior Vice President, Eisai
Past President, RAPS
Chair, Regulatory Science Committee, International Federation of Pharmaceutical Manufacturers and
Associations (IFPMA)
vii
Foreword
Postapproval changes are a vital part of medicines development and regulatory affairs. These changes reflect
the dynamic and iterative nature of science and how products develop and mature across the lifecycle.
The postapproval phase consumes more resources and costs than the initial development of medicines.
The proportions vary across products and therapeutic fields, but on average, today exceed 65% of the total
research and development spend. Yet this area has received relatively little attention until recently.
RAPS new book, Postapproval Changes for Drugs, is a welcome exception. This practical guide
covers the breadth of issues which encompass postapproval changes, ranging from the important but
more routine matters, such as marketing authorization transfers, administrative changes, late phase
renewals through to additional indications. This book covers these and many more matters from a
comprehensive global perspective by detailing and exploring the differences between the Americas,
Europe, Asia, Middle East and North Africa, and sub-Saharan Africa. The global coverage is important
because despite the great efforts for harmonization through the International Council for Harmonisation
of Technical Requirements for Pharmaceuticals for Human Use (ICH) and in particular, the ICH
Q12 guideline addressing technical and regulatory considerations for pharmaceutical product lifecycle
management, major differences in legislative approach remain.
Section II has authoritative chapters on the handling of quality and chemistry, manufacturing, and
control changes. Here we see the differences in approach from tacit approval, with a do and tell approach
through to strict approach on variation changes in Europe which has still to fully embrace the changes
set out in ICH Q12. This matters because of the impact it has in low- and middle-income countries with
the delays in approving product quality changes and the impact on the supply chain and costs of having
to maintain large inventories of different and older product forms. The chapters highlight the ongoing
attempts to resolve these burdens which are important to both public health and access to medicines.
Section III on safety and product information related changes postlaunch and Section V on
postmarketing surveillance and risk management are very welcome additions since these are rightly
becoming a major focus and an expanding area of postapproval changes.
A key and accelerating global trend is for more conditional approvals with a growing number of
postapproval commitments. It is excellent to see this topic discussed in Section IV of the publication.
When I was president of RAPS we introduced the tagline, “advancing public health through
knowledge and regulatory science.” This publication furthers this objective by giving an authoritative
account of the regulation of postapproval changes across the globe. It is not only a great reference text,
but it should be a wake-up call for introducing further change to this subject, which is so important for
all the stakeholders but above all for patient access to medicines.
David Jefferys, MD
Senior Vice President, Eisai
Past President, RAPS
Chair, Regulatory Science Committee, International Federation of Pharmaceutical Manufacturers and
Associations (IFPMA)