24 BioPharm International eBook December 2019 www.biopharminternational.com
tion, but for the 2015 edition, there
was a significant delay in the avail-
ability of the English version, which
made it difficult for multi-national
companies to comply with the
updated requirements. For the ChP
2020 edition, there are indications
that the English translation will
be available more quickly after the
Chinese version, which will be help-
ful in the implementation activities
for industry.
A new edition of the Russian
Phar macopoeia is a lso ta rgeted
every five years, but the actual pub-
lication has not strictly adhered
to this intended schedule. These
off icial updates to the Russian
Pharmacopoeia are provided on the
commission website in Russian
only; an English translation is
not available. The challenges with
publication schedules and transla-
tions again make it critical to the
success of a company's compen-
dial vigilance program to have a
strong connection with their local
contact group to provide access
to speedy t ra nslat ions of pro -
posed and official items for assess-
ment. The urgency for receiving
the translation can be reduced as
some pharmacopoeias (e.g., Russian
Phar macopoeia) allow a delayed
implementation timing due to the
lack of the information in English.
However, this is not the case with
all national pharmacopoeias (e.g.,
ChP) where a very short time may
be provided for compliance with
t he updated requ i rements fol-
lowing publication in the local
language. In the case where imple-
mentation follows a short timeline,
connection with the company's
local regulatory group (or other
identified f unction) to prov ide
the translation is critical to ensure
on-time compliance. Additional
information about the pharmaco-
poeias in India, Korea, and Brazil is
provided in
Table II.
CONCLUSION
The revision processes used by the
pharmacopoeias, and their asso-
ciated schedules for publication
of proposed and official updates
reveal some similarities, but also
many differences between global
a nd nat iona l pha r macopoeias.
Pharmacopoeial revision activities
are inextricably bound to the sur-
veillance activities carried out by
the bio/pharmaceutical industry.
The next article in this series will
take a closer look at the industry
processes to monitor the signifi-
cant volume of changes published
in t he pha r macopoeias a nd to
remain compliant with the cur-
rent requirements.
ACKNOWLEDGMENT
The authors gratefully acknowl-
edge the contribution of Susan J.
Schniepp for her technical review
and helpf ul suggestions during
the preparation of this series of
articles.
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The irregular
publication
schedules
of national
pharmacopoeias
and the need for
translation pose
challenges for
industry
surveillance
activities.
Regulatory Sourcebook Pharmacopoeia Compliance Series
