Issue link: https://www.e-digitaleditions.com/i/1193175
www.biopharminternational.com eBook December 2019 BioPharm International 19 proposal. While perhaps not con- troversial, these minor revisions of ten st i l l have i mpac t, a nd a company may find it challenging to implement the changes quickly, after they are seen for the first time as official updates. USP 's "Ru les a nd P rocedu res of the Council of Experts" spec- if y processes t hat ca n be used to m a ke o f f ic i a l r e v i s io n s to the USP– NF more quick ly than through their standard process (8,11,12). These accelerated pro- cesses include the publication of interim revision announcements (IR As), rev ision bulletins (R Bs), a nd e r r at a, wh ic h a r e p o ste d on t he USP website on a reg u- lar (monthly) schedule. IRAs are first published as proposals in the forum, given a 90-day notice and comment period, then posted as official text on the USP website and incorporated into the next Table II. Publication schedule for new editions/supplements (official updates). Pharmacopoeia Official publication Media type Official language (Translation) Frequency (Publication date) Notes European Pharmacopoeia (Ph. Eur.) Main Edition Online and hard copy English and French New edition ever y 3 years (Publish: July. Of ficial: Januar y) Supplements Online and hard copy English and French 8 supplements over 3-year cycle (Publish: Oc tober, Januar y, July) British Pharmacopoeia (BP) Main Edition Online and hard copy English New edition ever y year. (Publish: August. Of ficial: Januar y.) Updates are made to the BP online publication (not the hard copy version) to reflect Ph. Eur. supplements. Supplements N/A English No supplements are published United States Pharmacopeia (USP) Main Edition Online English (Spanish) New edition ever y year (Publish: November. Of ficial: May) Final hard copy publication of USP occured in November 2019. Only online publication available after that date. Supplements Online English (Spanish) 2 supplements per year (Publish: Februar y, June) Japanese Pharmacopoeia (JP) Main Edition Hard copy Japanese (English) New edition ever y 5 years Free online PDF versions of the official JP edition and supplements are available on the health authority website in both Japanese and English. Supplements Hard copy Japanese (English) 2 supplements published in year 2 and 4 of 5-year cycle Chinese Pharmacopoeia (ChP) Main Edition Hard copy Chinese (English) New edition ever y 5 years Supplements Hard copy Chinese 2 supplements over 5-year cycle (No English translation) Indian Pharmacopoeia (IP) Main Edition Hard copy English New edition ever y 4 years Supplements Hard copy English 2 supplements (addenda) published over 4-year cycle State Pharmacopoeia of the Russian Federation (SP RF ) Main Edition Online Russian New edition published but not on a regular cycle. (No English translation.) Publication of supplements unknown. Free online version of the official SP RF edition is available on the health authority website in Russian (only). Korean Pharmacopoeia (KP) Main Edition Hard copy Korean (English) New edition targeted ever y 5 years. Publication of supplements unknown. Free online PDF version of the of ficial KP edition is available on the health authority website in English. Brazilian Pharmacopoeia (FBras) Main Edition Hard copy Por tuguese (English) New edition published but no defined periodicity. Publication of supplements unknown. Free online version of FBras may be available on the health authority website in Por tuguese and English Regulatory Sourcebook Pharmacopoeia Compliance Series Contin. on page 22