Pharmaceutical Technology - December 2019

Pharmaceutical Technology - Regulatory Sourcebook

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Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 23 Table I. Regulatory acceptance of "global pharmacopoeias" in countries around the world. Detailed Consideration of Global and National Pharmacopoeias (cont.) for articles awaiting approval by FDA (13). USP also publishes stimuli articles, which present initial thinking of the experts in their development of new or revised general chapters or other standards and provide additional time for comments from stakeholders. The wide array and frequent use of these other approaches to notify stakeholders of proposed and of- ficial updates makes routine (monthly) monitoring of the USP website an important component of a company's surveillance process to remain in compliance with current requirements. Revision process and publication schedule for JP Shifting focus from the global to the national pharmaco- poeias, special consideration should be given to JP, because it does not fit as easily into the global or national designa- tions. Because it is primarily required in Japan only, the JP is a national pharmacopoeia according to the authors' definitions. The revision process and regular publication schedule for JP, however, more closely align with those of the global pharmacopoeias, making it simpler for a company to include JP in their surveillance activities. As with the global pharmacopoeias, the JP revision process includes steps that are internal to the organization and steps that connect with external stakeholders, with communication of proposed and official updates occurring on a regular basis. Table I shows that proposed updates are published four times per year in the JP forum on an established schedule. The JP forum is European Pharmacopoeia British Pharmacopoeia United States Pharmacopeia European Union* Austria* Belgium* Bosnia and Herzegovina* Bulgaria* Croatia* Cyprus* Czech Republic* Denmark* Estonia* Finland* France* Germany* Greece* Hungary* Iceland* Ireland* Italy* Latvia* Lithuania* Luxembourg* Macedonia* Malta* Montenegro* Netherlands* Norway* Poland* Portugal* Republic of Moldova* Romania* Serbia* Slovak Republic* Slovenia* Spain* Sweden* Switzerland* Turkey* Ukraine* United Kingdom* Algeria Argentina Australia Brazil Canada Chile China Colombia Costa Rica Egypt Guatemala Hong Kong India Indonesia Iraq Israel Jordan Kenya Lebanon Malaysia Morocco New Zealand Nigeria Panama Peru Philippines Republic of Korea Saudi Arabia Singapore South Africa Tunisia United Arab Emirates Vietnam Algeria Argentina Australia Brazil Canada Chile China Colombia Costa Rica Egypt Guatemala Hong Kong India Indonesia Iraq Israel Jordan Kenya Lebanon Malaysia Morocco New Zealand Nigeria Panama Peru Philippines Republic of Korea Saudi Arabia Singapore South Africa Thailand Tunisia United Arab Emirates United Kingdom Venezuela Algeria Argentina Australia Brazil Canada Chile China Colombia Costa Rica Egypt Guatemala Hong Kong India Indonesia Iraq Israel Jordan Kenya Lebanon Malaysia Morocco New Zealand Nigeria Panama Peru Philippines Republic of Korea Saudi Arabia Singapore South Africa Tunisia United Arab Emirates United States Venezuela Vietnam * Signatory to the European Pharmacopoeia Convention.

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