Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 41
The CPC has also announced its intention to work with
the World Health Organization "… to jointly establish a
pharmacopoeia exchange mechanism and a multi-national
pharmacopoeia comparison information platform to lay
the technical foundation for promoting international phar-
macopoeia coordination" (44). In the authors' experience,
it is evident the CPC is open to science-based comments
from multinational companies and has shown a willing-
ness to adopt new concepts. With the ongoing changes
in the regulatory environment, one can envision the ChP
will become more important in product registrations for
the Asia Pacific region, alongside the JP. Clearly, for any
company intending to license and market a drug product
in China, compliance to the ChP is now mandatory and a
strategy on how to achieve and maintain this compliance
should be developed.
Brazil. Brazil joined ICH in November 2016 (45) and im-
plementation of several ICH guidance documents has oc-
curred or is being planned (46). This change will impact
general chapters and monograph requirements in the most
recently published 6th edition of the Brazilian Pharmaco-
poeia (FBras) and future editions in the coming years. Com-
panies will need to monitor the publication for any changes
that impact their company's products.
Russia. Russia is currently an ICH observer, and with this
status, has not yet implemented any of the ICH guidance
documents (47). However, the latest XIV edition of the Rus-
sian Pharmacopoeia (SP RF) was published in December
2018, and it contains more than 60 revised or new general
chapters. The addition of chapters highlights the need for
a company to establish monitoring of the SP RF. The reg-
ulation requiring companies to perform gap assessment of
their procedures against the Russian normative document
includes baseline compliance to the SP RF general chapters.
Companies must comply with these requirements at the next
license renewal for the drug product or by 2022, whichever
comes first. Additionally, there is increased activity from
the Russian Ministry of Health (MoH) to request the de-
velopment of new product monographs in the SP RF. This
increased activity from the MoH indicates companies need
to keep Russia on their radar to remain compliant.
New regional pharmacopoeias. Ef forts to establish new
pharmacopoeias in the Eurasian Economic Union (EAEU),
which includes Russia, and MESCOUR region, which in-
cludes Brazil, were described in a previous article (3). As
these new pharmacopoeias come closer to reality in the
coming years, it is important for a compendial affairs group
to monitor the proposed documents being posted, to com-
ment as appropriate, and to ensure the company has a plan
to comply when the requirements are published as official.
It is not yet clear if these new publications will replace the
existing national pharmacopoeias in their respective coun-
tries or if the new regional publications will be harmonized
with any of the remaining national pharmacopoeias that
may continue to exist.
Conclusion
This brings to a close the series of articles on pharmaco-
poeia compliance. It is the authors' hope that the infor-
mation presented has been helpful and the ideas for the
future will continue, especially efforts aimed at harmoni-
zation to achieve global pharmacopoeia standards. There
is a continuing need for all stakeholders to work toward
the goal of a world where there is "no need for translation";
where the following is achieved:
• Consistent standards published by pharmacopoeias
in the languages needed by their stakeholders
• A global pharmaceutical industry that can ensure
compliance with these standards, because they con-
tain consistent requirements
• Regulators who can use these globally consistent
standards to help ensure the quality of medicines
• No need for translation, because all the pharmaco-
poeias are saying the same thing.
The authors put forth a bold challenge to readers: let
us make every effort to ensure that the pharmacopoeias
reach a state of harmonization that will support the ob-
jective of "no need for translation." If this goal of global
pharmacopoeia standards is realized, even if it takes as
long as 50 years, then it can be asserted that the pharma-
copoeias, regulators, and the bio/pharmaceutical industry
have truly done all they can in this important area, work-
ing together to further their shared mission of effectively
serving patients globally.
Acknowledgment
The authors gratefully acknowledge the contribution of
Susan J. Schniepp for her technical review and helpful sug-
gestions during the preparation of this series of articles.
References
1. J.M. Wiggins and J.A. Albanese, "Why Pharmacopoeia Compli-
ance Is Necessary," Pharmaceutical Technology Regulatory Source-
book eBook, 28–34 (September 2019).
2. J.M. Wiggins and J.A. Albanese, "Why Pharmacopoeia Compli-
ance Is Difficult," Pharmaceutical Technology Regulatory Source-
book eBook, 36–42 (September 2019).
3. J.M. Wiggins and J.A. Albanese, "A Brief History of Pharmacopoe-
ias: A Global Perspective," www.PharmTech.com (September 2019).
4. J.M. Wiggins and J.A. Albanese, "Global Pharmacopoeia Standards:
Why Harmonization is Needed," Pharmaceutical Technology Regu-
latory Sourcebook eBook, 43–47 (September 2019).
5. J.M. Wiggins and J.A. Albanese, "Harmonization Efforts by Phar-
macopoeias and Regulatory Agencies," www.PharmTech.com (Sep-
tember 2019).
6. J.M. Wiggins and J.A. Albanese, "Revision Process for Global/Na-
tional Pharmacopoeias," Pharmaceutical Technology Regulatory
Sourcebook eBook, 17–25 (December 2019).
7. J.M. Wiggins and J.A. Albanese, "Surveillance Process for Industry:
Monitoring Pharmacopoeia Revisions," Pharmaceutical Technology
Regulatory Sourcebook eBook, 26–37 (December 2019).
8. J.M. Wiggins and J.A. Albanese, "Monograph Development:
Why and When to Participate," Pharmaceutical Technology
Regulatory Sourcebook eBook, 14-23 (March 2020).
