Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 25
company's comments from English to Chinese so a response
can be provided back to the pharmacopoeial authority.
For the State Pharmacopoeia of the Russian Federation
(SP RF or Russian Pharmacopoeia), proposed updates are
not available on a regular schedule, and when they appear,
they are in Russian only, with a comparatively short time-
frame to submit comments. The company's local contact
group in Russia can help monitor and translate the items
with potential impact.
For the Indian Pharmacopoeia (IP), proposals for new and
revised requirements are also posted on the commission's
website on an ad hoc basis. Even though they are published
in English, the irregular publication schedule for these items
again makes it helpful to have a connection with the local
contact group in India to assist in monitoring the website.
The commenting period allowed for IP proposals also seems
to be irregular and often quite short compared to the global
pharmacopoeias, which makes it difficult to respond to the
proposals. For many of the other national pharmacopoeias,
there may be even less transparency in their public notifica-
tion and commenting processes.
For national pharmacopoeias, the governing commis-
sion's workplan typically coincides with the publication
cycle. The publication schedules for official updates (15)
also reveal differences between the national pharmacopoe-
ias (Table II), with translation from the local language being
another complicating factor for compliance. A new edition
of ChP containing official updates is published every five
years in the Chinese language. The ChP commission pro-
vides an English translation, but for the 2015 edition, there
was a significant delay in the availability of the English ver-
sion, 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 helpful in the implementation activities for
industry.
A new edition of the Russian Pharmacopoeia is also tar-
geted every five years, but the actual publication has not
strictly adhered to this intended schedule. These official up-
dates to the SP RF are provided on the commission website
in Russian only; an English translation is not available. The
challenges with publication schedules and translations again
make it critical to the success of a company's compendial
vigilance program to have a strong connection with their
local contact group to provide access to speedy translations
of proposed and official items for assessment. The urgency
for receiving the translation can be reduced as some phar-
macopoeias (e.g., SP RF) allow a delayed implementation
timing due to the lack of the information in English. How-
ever, this is not the case with all national pharmacopoeias
(e.g., ChP) where a very short time may be provided for com-
pliance with the updated requirements following publica-
tion in the local language. In the case where implementa-
tion follows a short timeline, connection with the company's
local regulatory group (or other identified function) to pro-
vide the translation is critical to ensure on-time compliance.
Additional information about the pharmacopoeias in India,
Korea, and Brazil is provided in Table II.
Conclusion
The revision processes used by the pharmacopoeias, and
their associated schedules for publication of proposed and
official updates reveal some similarities, but also many
differences between global and national pharmacopoeias.
Pharmacopoeial revision activities are inextricably bound to
the surveillance activities carried out by the bio/pharmaceu-
tical industry. The next article in this series will take a closer
look at the industry processes to monitor the significant
volume of changes published in the pharmacopoeias and to
remain compliant with the current requirements.
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.
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