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20 BioPharm International eBook March 2020 www.biopharminternational.com Regulatory Sourcebook Pharmacopoeia Compliance Series Industry timing The other timing perspective to consider for monograph develop- ment is that of an individual com- pany, and this, in turn, may vary based on whether the company is in the innovator or generic sector of the industry ( Figure 2). After an innovator company (Manufacturer 1 in Figure 2) receives regulatory approval for a new drug applica- tion containing a new chemical entity, there is a period of patent protection and marketing exclu- sivity during which the innovator is the single source for the prod- uct. During this time period, gener- ic-drug companies begin to develop similar versions of the drug sub- stance and product, in terms of pharmaceutical and therapeutic equivalence. One goal is to become the first company (Manufacturer 2 in Figure 2) to market a generic version of t he produc t, rea liz- ing all the business benefits that accompany this position. Once the first generic version has been approved, which may occur per- haps 10 –15 years after the inno- vator's approval, followed by the approval of other generic versions, potentially from many other com- panies around the world, the prod- uct situation changes to reflect this multi-source availability. At some point during the prod- uct's lifecycle, the possible devel- opment of a monograph emerges, at which point the need and value of this specific public standard is weighed against the existing reg- ulatory approval for the product. The monograph will contain the specifications—tests, analy tical procedures, and acceptance cri- teria—that help ensure the iden- tity, strength, quality, and purity of the drug substance and product. It becomes necessary for all com- panies with regulatory approval to comply with the requirements established in the monographs for the drug substance and product. Additionally, as stated in the GPhP guidance, "Specifications that limit market access by, for example, favor- ing one manufacturer to the exclu- sion of others should be avoided" (8). This statement is intended to maintain focus on the benefit to patients worldwide in having pub- lic standards that support access to medicines from innovator and generic-drug companies with con- sistent and appropriate quality. T he ea rliest oppor t unit y for monograph submission belongs to the innovator company having the initial regulatory approval, during the period of patent protection and marketing exclusivity. Once the decision has been made whether to submit the necessary informa- tion for monograph development, consideration then turns to when to submit the information. Many product-specific points are import- ant in this consideration, including ongoing manufacturing and ana- lytical changes that may impact the applicable specifications, as well as the timing for potential entry of generic competition. Manufacturer … Manufacturer 3 Regulatory Approval Official Monographs (Drug Substance / Drug Product) Manufacturer 1 • Identity • Strength • Quality • Purity Prospective Manufacturer 2 • Identity • Strength • Quality • Purity Single-Source Product Multi-Source Product Harmonization Monograph Change Control? Regulatory Approval Figure 2. Monograph timing considerations for industry.