The globalization of biomedical product development is prompting a new look at the barriers erected by divergent national
and regional data requirements and policies governing drug production and quality. While efforts to establish common standards
for drug testing and product quality through the International Conference on Harmonization (ICH) have streamlined biopharmaceutical
development and regulation in industrialized nations, the emergence of more active national regulatory authorities and regional
alliances illustrate the need for a broader international approach to setting regulatory requirements. The new goal is convergence
of policies and practices, if not total harmonization.
Pharmaceutical manufacturers regard common regulatory policies as key to facilitating access to foreign markets, to patients
from other regions for clinical trials, and to lower cost suppliers and operational support, observed Peter Honig, vice-president
global regulatory affairs at AstraZeneca. Honig noted the importance of standards in reducing the cost and time of drug development
in a February workshop organized by the Institute of Medicine (IOM) Forum on Drug Discovery, Development and Translation (1).
In recent years, IOM has examined clinical trial operations and development of medical countermeasures, new treatments for
tuberculosis, and drug-diagnostic combinations. This gathering of regulatory authorities and industry leaders from around
the world sought to take a fresh look at international regulatory issues in the face of uncertainty about the future of the
ICH standards-setting process, concerns about the growing cost of new drug development, and alarm over the increase in substandard
medical products in all regions.
In addition to highlighting problems created by divergent clinical research and data requirements, participants emphasized
the need for common technical standards to ensure drug quality, reduce redundant manufacturing plant inspections, and help
regulators detect substandard products and ensure the integrity of increasingly long supply chains. Individual countries differ
in how they implement ICH quality standards, adding specifications and content to the common dossier format for submitting
chemistry, manufacturing, and controls (CMC) information, reported Diane Zezza, vice-president and global head for regulatory
CMC at Novartis, in summarizing concerns related to manufacturing standards and processes. And postapproval changes are even
more divergent in terms of data requirements and timing of filings, a situation that can inhibit continuous improvement efforts.
The group urged harmonization efforts to target differing import-testing requirements, which can lead to product recalls and
shortages. A related goal is to reduce differences in how field inspectors apply and interpret GMPs and cite violations in
inspection reports. Multiple pre-approval inspections by different regulatory authorities are a perennial burden on manufacturers.
One encouraging sign is the willingness of more countries to accept inspection standards established by the Pharmaceutical
Inspection Convention and Co-operation Scheme (PIC/S) and to voluntarily share redacted GMP information and inspection reports
on active ingredients.