Issue link: https://www.e-digitaleditions.com/i/1193175
www.biopharminternational.com eBook December 2019 BioPharm International 21 Regulatory Sourcebook Pharmacopoeia Compliance Series Detailed Consideration of Global and National Pharmacopoeias (cont.) registrations for Japan. Similarly, compliance with the Chinese Pharmacopoeia (ChP) might only be included in the registration for China, even though ChP may also be accepted in other countries. T he designation of Ph. Eur. , B P, and U S P a s global pharmacopoeias is a practical consideration, which can help address some of the challenges that a company faces in complying with the various pharmacopoeias, while aligning and simplifying the information listed in drug product registrations around the world. Still, the value of national pharmacopoeias should not be underestimated because they are critical to supporting access and ensuring quality of medicines in their respective countries. References 1. S. Keitel, "The Ph. Eur.: A Successful Example of How a Pharmacopoeia Supports and Fosters Implementation of Regulatory Texts," Presentation at 2nd PDA Conference on International Developments in the Pharmacopoeial Landscape, Geneva, Switzerland (May 16-17, 2019). 2. BP, "The British Pharmacopoeia," pharmacopoeia.com. 3. USP, "Legal Recognition of USP Standards," USP.org. 4. T. Ando, "Working Principles of Japanese Pharmacopoeia," Presentation at 2nd PDA Conference on International Developments in the Pharmacopoeial Landscape, Geneva, Switzerland (May 16-17, 2019). 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* Hungar y* Iceland* Ireland* Italy* Latvia* Lithuania* Luxembourg* Macedonia* Malta* Montenegro* Netherlands* Nor way* Poland* Por tugal* 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. Table I. Regulatory acceptance of "global pharmacopoeias" in countries around the world.

