Regulatory acceptance
The third principle of compendial globalization is not focused on the pharmacopeias, but rather on the regulatory agencies.
Compendial globalization can only succeed if the regulators are willing to accept the outcomes based upon the standardized
pharmacopeial practices and pharmacopeial collaboration. Having harmonized compendial processes and interchangeable standards
will aid in the regulators' efforts to ensure the quality of medicines, in light of the challenges created by the increasingly
complex global supply chain.
Acceptance of compendial globalization by the regulatory agencies will be facilitated by their participation in the development
of the underlying principles of standardized pharmacopeial practices and pharmacopeial collaboration. The existing framework
for regulatory review and comment on compendial standards (monographs and general chapters) provides further assurance of
appropriate quality for drug products and ingredients. It is envisioned that harmonized and interchangeable compendial standards
could help to harmonize compendial information in regulatory submissions, reducing the number of postapproval changes submitted
by industry, thereby removing the need for this additional review and approval by health authorities. Regulatory acceptance
of the outcomes of compendial globalization will also provide a baseline for the regulatory expectations for compendial testing
that are reviewed during inspections. These aspects will ultimately provide consistent quality medicines for global patients
without an additional regulatory burden.
Benefits of compendial globalization
The ultimate beneficiaries of compendial globalization are patients worldwide through the increased availability of affordable
medicines with appropriate, consistent, and globally applicable quality standards. This benefit is achieved through the harmonized
compendial requirements which facilitate drug development, specification setting, global drug product registrations, and inspection
of facilities. Additional benefits come from the simplification of the supply chain and quality assurance processes for global
medicines.
Figure 2: Current state of monograph development.
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Another practical benefit is the improved utilization of resources by global stakeholders (i.e., industry, pharmacopeias,
and regulators) who are directly impacted by compendial standards. This benefit is achieved by eliminating redundancies in
industry, pharmacopeial, and regulatory processes. For the pharmaceutical industry, there is direct benefit in harmonized
quality requirements which eliminate redundant testing that provides no additional benefit to the patient. Both the industry
and pharmacopeias also benefit from simplification of processes for developing compendial standards (see Figures 2 and 3).
Figure 3: Proposed state of monograph development.
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The current process for developing a new monograph for a single drug substance or product (see Figure 2) requires parallel
and redundant work activities. A company may develop and submit multiple proposals to several different pharmacopeias. Each
pharmacopeia then follows the steps of its own process for monograph elaboration, typically resulting in different outcomes
that are published for review and comment in pharmacopeial forums. The company must monitor each of the respective forums,
and respond to the different drafts. Once the pharmacopeias take account of the comments from all impacted stakeholders, including
those from other companies and regulatory agencies, the different monographs are published as official. All impacted companies
must then complete appropriate change control to their testing standards, as needed, to ensure compliance with the disharmonized
monograph requirements.
The work for all stakeholders is simplified by compendial globalization (see Figure 3), where a harmonized monograph results
from a single submission by the company. Using the standardized practices and collaboration, one pharmacopeia is able to develop
the harmonized monograph and other pharmacopeias are able to adopt this standard, based on collaboration between the pharmacopeias
and with the submitter of the monograph. This frees up resources for the other pharmacopeias, enabling them to develop other
standards, rather than duplicating the effort for the first monograph. The resulting harmonized compendial standards reduce
the complexity of regulatory review of registrations and inspection of facilities. One globally applicable quality standard
would exist, regardless of which pharmacopeia might be referenced in a registration or used for release testing. These outcomes
provide global patient benefit and make the pursuit of compendial globalization a worthwhile effort.
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