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Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
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pilation and submission. For example, since July
2015, eCTD submissions have been mandatory
for all EMA centralized applications.
Many countries do not accept eCTD yet, but
may accept a non-eCTD electronic submission
(NEES). NEES differs from an eCTD because it
does not have an XML backbone or MD5 check-
sum, as defined by ICH. Rather, it is a collection
of electronic files organized in folders.
International Cooperation and
Harmonization
As organizations seek to increase their drug
development programs’ efficiency by increasing
their focus on early and simultaneous registra-
tion in multiple global markets, regulators also
are growing more aware of the need for global
harmonization of requirements and processes.
Efforts to increase global harmonization are con-
tinuing through a range of activities in addition
to ongoing ICH processes.
ICMRA
ICMRA provides direction for a range of areas
common to many regulatory authorities’ missions.
It identifies areas for potential synergies among
regulators and facilitates, where possible, interna-
tional leveraging and resource savings by building
confidence and deeper regulator collaboration.
International Generic Drug Regulators
Programme (IGDRP)
IGDRP was created to promote collaboration and
convergence in generic drug regulatory programs
for regulatory agencies from several countries.
International Regulators Consortium
This consortium was formed in 2007 by like-
minded regulatory authorities to promote greater
regulatory collaboration and alignment of regu-
latory requirements.
References
1. Draft Guidance for Industry and Review Staff: Target
Product Profile—A Strategic Development Process Tool.
Draft (2007). FDA website. https://www.fda.gov/
media/72566/download. Accessed 10 October 2019.
2. Organisation of the Common Technical Document for the
Registration of Pharmaceuticals for Human Use M4(R3).
ICH website. https://database.ich.org/sites/default/
files/M4_R4__Guideline.pdf. Accessed 26 November
2019.
3. International Organization for Standardization.
ISO 31000: 2009 Risk management Principles and
Guidelines.
4. Eichler HG, Baird LG, Barker R, Bloechl-Daum B,
Borlum-Kristensen F et al. “From adaptive licensing
to Adaptive Pathways: delivering a flexible life span
approach to bring new drugs to patients.” Clin
Pharmacol Ther 2015 97: 234–246.
5. Lu Z. “Information technology in pharmacovigilance:
benefits, challenges and future directions from industry
perspectives.” Journal of Drug Healthcare and Patient
Safety. 2009:1 35–45.
6. Electronic Common Technical Document (eCTD) M8.
ICH website. https://www.ich.org/page/ich-electronic-
common-technical-document-ectd-v40. Accessed 26
November 2019.
Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
pilation and submission. For example, since July
2015, eCTD submissions have been mandatory
for all EMA centralized applications.
Many countries do not accept eCTD yet, but
may accept a non-eCTD electronic submission
(NEES). NEES differs from an eCTD because it
does not have an XML backbone or MD5 check-
sum, as defined by ICH. Rather, it is a collection
of electronic files organized in folders.
International Cooperation and
Harmonization
As organizations seek to increase their drug
development programs’ efficiency by increasing
their focus on early and simultaneous registra-
tion in multiple global markets, regulators also
are growing more aware of the need for global
harmonization of requirements and processes.
Efforts to increase global harmonization are con-
tinuing through a range of activities in addition
to ongoing ICH processes.
ICMRA
ICMRA provides direction for a range of areas
common to many regulatory authorities’ missions.
It identifies areas for potential synergies among
regulators and facilitates, where possible, interna-
tional leveraging and resource savings by building
confidence and deeper regulator collaboration.
International Generic Drug Regulators
Programme (IGDRP)
IGDRP was created to promote collaboration and
convergence in generic drug regulatory programs
for regulatory agencies from several countries.
International Regulators Consortium
This consortium was formed in 2007 by like-
minded regulatory authorities to promote greater
regulatory collaboration and alignment of regu-
latory requirements.
References
1. Draft Guidance for Industry and Review Staff: Target
Product Profile—A Strategic Development Process Tool.
Draft (2007). FDA website. https://www.fda.gov/
media/72566/download. Accessed 10 October 2019.
2. Organisation of the Common Technical Document for the
Registration of Pharmaceuticals for Human Use M4(R3).
ICH website. https://database.ich.org/sites/default/
files/M4_R4__Guideline.pdf. Accessed 26 November
2019.
3. International Organization for Standardization.
ISO 31000: 2009 Risk management Principles and
Guidelines.
4. Eichler HG, Baird LG, Barker R, Bloechl-Daum B,
Borlum-Kristensen F et al. “From adaptive licensing
to Adaptive Pathways: delivering a flexible life span
approach to bring new drugs to patients.” Clin
Pharmacol Ther 2015 97: 234–246.
5. Lu Z. “Information technology in pharmacovigilance:
benefits, challenges and future directions from industry
perspectives.” Journal of Drug Healthcare and Patient
Safety. 2009:1 35–45.
6. Electronic Common Technical Document (eCTD) M8.
ICH website. https://www.ich.org/page/ich-electronic-
common-technical-document-ectd-v40. Accessed 26
November 2019.