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www.biopharminternational.com eBook December 2019 BioPharm International 23 opportunity to respond to JP pro- posals make it important for the compend ia l a f fa i r s g roup i n a company to have a strong connec- tion with their local contact group in Japan, if available. Compliance with compendial requirements in Japan is also made more difficult by the publication (not on a regu- lar schedule) of official compendia other than JP. Examples of these include Japanese Phar maceutical Excipients; Japanese Pharmaceutical C o d e x ; J a p a n 's S p e c i f i c a t i o n s and Standards for Food Additives; R e q u i r e m e n t s f o r A n t i b i o t i c Products of Japan; and Minimum Requirements for Biological Products in Japan. The health authorities in Japan expect compliance with t h e s e a d d it i o n a l c o m p e n d i a l requirements if standards do not otherwise exist in the official JP. REVISION PROCESS AND PUBLICATION SCHEDULE FOR OTHER NATIONAL PHARMACOPOEIAS Looking at the revision process and publication schedules for other national phar macopoeias, it is apparent that there are differences from the global pharmacopoeias and from each other. These dif- ferences, in particular the irregu- lar publication schedules and the need for translation, pose challenges for industry surveillance activities and necessitate partnership with a company's local contact group, if available, in these countries to help with compliance. Differences between the pharmacopoeias have been explored in the International Meetings of World Pharmacopoeias convened by the World Health Organization (14, 15), which have focused on ways to achieve inter- national harmonization among the many pharmacopoeias. One outcome of t he se d i sc u ssion s has been the publication of Good Pharmacopoeial Practices (GPhP), which defines approaches and poli- cies in establishing pharmacopoeial standards (16). One key consider- ation contained in the GPhP docu- ment is the assurance of an open and transparent process through- out the development and revision of pharmacopoeial standards. This process calls for engaging stake- holders in the process by making workplans available and providing adequate and timely public notifica- tion with allowances for comment- ing. While the revision processes for national pharmacopoeias typically follow similar steps as previously described, there is not always a sim- ilar level of transparency as seen with the global pharmacopoeias. National pharmacopoeias do not publish their proposed revisions for public comment at a predetermined time; it typically happens in an ad-hoc fashion. The lack of a regular schedule for notification of propos- als contributes to the challenge for industry in monitoring the national pharmacopoeias. The Chinese Pharmacopoeia (ChP) commission, for example, publishes items for comments on its web- site when a sufficient number of new and revised monographs and general chapters have progressed through their development pro- cess. These proposals are published in Chinese only. Comments on first draft items typically receive a 9 0 - day com ment i ng per iod, whereas items that are second or subsequent drafts typically get only 30 days for commenting. Many large multi-national companies find it difficult to meet the comment- ing deadlines for ChP since the pro- posals must first be translated into English to enable assessment of the potential impact. It is important, therefore, for the compendial affairs function in a company to have a strong connection to the local con- tact group in China, if available (e.g., regulatory affairs, quality, etc.) to perform the monitoring, identifi- cation, and translation of items with potential impact. If needed, the local group can also translate the company's comments from English to Chinese so a response can be pro- vided 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 sched- ule, and when they appear, they are in Russian only, with a compara- tively short timeframe to submit comments. The company's local contact group in Russia can help monitor and translate the items with potential impact. For the Indian Phar macopoeia (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 irregu- lar publication schedule for these items again makes it helpf ul to have a connection with the local contact group in India to assist in monitoring the website. The com- menting period allowed for IP pro- posals 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 notification and com- menting processes. For nat iona l pha r macopeias, the governing commission's work- plan typically coincides with the publication cycle. The publication schedules for official updates (15) also reveal differences between the national pharmacopoeias ( Table II), with translation from the local lan- guage 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 com- mission provides an English transla- Regulatory Sourcebook Pharmacopoeia Compliance Series