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18 BioPharm International eBook March 2020 www.biopharminternational.com Regulatory Sourcebook Pharmacopoeia Compliance Series ALL FIGURES COURTESY OF THE AUTHORS. needed. It is a daunting task to get approval for each new monograph submission, with the scientific data required to support the elaboration activities. It is best to embed the monograph strateg y into estab- lished compendial processes, so it becomes a "routine" activity that requires limited internal approvals to proceed. CONSIDERATION OF APPROPRIATE TIMING FOR MONOGRAPH SUBMISSION The GPhP g uidance states that pharmacopoeial standards should be available for drug products and their active ingredients at an appro- priate time to support and benefit patients through the availability of medicines with consistent quality (8). The critical question within this statement is what is an "appro- priate time". If a company decides to participate in the development of a new monograph, they must ask when they will start the pro- cess. The appropriate timing will typically vary for each company, for each situation, or even for each product in a company's portfolio. As with the prior question of whether a company should participate in monograph development, exploring the subsequent question of when to participate reveals there is not nec- essarily a consistent, single answer. Focusing on the question of tim- ing, two perspectives should be con- sidered: that of the pharmacopoeia and that of the industry. Pharmacopoeia timing T he process to develop a new monograph in the pharmacopoeia typically takes two to three years. Figure 1 shows the preferred tim- ing for new monog raph devel- opment f rom the v iew point of various pharmacopoeias, reflecting several considerations. Typically, the Ph. Eur. and USP monographs are the earliest to be elaborated, with the preferred Ph. Eur. tim- ing stated as five years post-ap- proval to take advantage of its P4 procedure (12), in which the nec- essary specifications and support- ing information are provided by a single company, usually the inno- vator, having regulatory approval for the product in Europe. This t i m i ng a l so cor resp ond s w it h the European Medicines Agency r eg u l ator y g u id a nc e conc e r n - ing mandatory renewal of a mar- keting authorization within five years of its granting in Europe (13). Under the P4 procedure, the Ph. Eur. Commission works to ensure that monographs are available a few years before the patent expiry date, thus making it possible for reg ulators to assess dossiers on generic drugs based on existing monographs in the pharmacopoeia (14). If the monograph submis- sion is too late to follow the P4 process, the Ph. Eur. monograph is developed (or revised) using the P1 process (15), in which multi- ple companies with approval for the drug product in Europe may participate in developing the tests, Regulatory Submission/Approval Marketing Exclusivity API Monograph Patent Expiration Product Monograph C o m m e r c i a l i z a t i o n S u p p l y Ea r l y D e ve l o p m e n t USP 7-8 Years Before Generic Entry BP After Ph.Eur. API Monograph Ph.Eur. 5-Years Post-Approval IP When 2-3 Local Manufacturers ChP/KP Timing? JP Timing? Figure 1. Monograph timing considerations for pharmacopoeias. IP is Indian Pharmacopoeia. Ph.Eur. is European Pharmacopoeia. USP is United States Pharmacopeia. BP is British Pharmacopoeia. JP is Japanese Pharmacopoeia. ChP is Chinese Pharmacopoeia. KP is Korean Pharmacopoeia.