Universal acceptance of electronic regulatory submissions
As noted above, we have seen a wide range of flexibility by regulators to avoid delays in patient access to new and existing treatments. Regulators around the world have permitted electronic files for Certificates of Pharmaceutical Products and Good Manufacturing Practices, and accepted all regulatory filings electronically (e.g., meeting packages and annual reports). This reduction in administrative burden—without reduction in quality of information being provided—has simplified regulatory processes while maintaining compliance, and facilitated more efficient use of resources.
Moreover, COVID‐19 has revealed the advantages to having real‐time and accurate product information for all countries. Electronic labeling provides the opportunity to immediately share with patients and healthcare providers changes in approved product information. While we recognize many regulators have already taken steps toward implementing electronic labeling, it is important to do so in a consistently accessible manner, seeking standards and interoperable solutions. 9