Evolving Global Requirements for Signal Notification to Health Authorities: How to Standardize and Harmonize Signal Communication

• Published in: Drug safety 2022-10, Vol.45 (10), p.1223-1223
• Main Authors: Pruvot, F, Navarcikova, S, Ray, L, Fiddes, H, Isleem, D, Ha, T, Maier, K, Kaehler, S
• Format: Article
• Language: English
• Subjects: Communication; Pharmacology; Pharmacovigilance; Safety; Signal processing
• ISSN: 0114-5916; 1179-1942

Introduction: Globally, the requirements and guidance on signal communication provided to marketing authorisation holders (MAHs) have evolved, requiring a global and harmonised approach with the aim to provide all Health Authorities (HAs) with the same information on signals, ideally at the same time. Objective: Define a global end-to-end process to streamline the signal information provided to HAs of International Reference for authorized medicinal products for human use respecting all global HA requirements while maintaining high scientific standards of signal communication. Methods: The oversight role of the Qualified Person for Pharmacovigilance (QPPV) in European Union (EU) was expanded to play an active role in the harmonized signal communication to HAs. Upon receipt of an MAH- or HA-identified signal or a HA-imposed safety action in the scope of the process (Day 0), a QPPV Notification is drafted by the QPPV Office. This draft is subsequently reviewed by subject matter experts, who are the MAHs pharmacovigilance (PV) and regulatory professionals (Day 1). The decision to disseminate is made by the EU QPPV and is communicated to the MAH affiliates on Day 2. Country PV and regulatory personnel determine the appropriateness of notification to the country HA. This notification is performed in accordance with local regulatory requirements using the standard scientific wording provided in the QPPV Notification, ensuring that HAs worldwide receive the same information (Day 3). In the case of country-specific requirements, such as additional data (information, documents, etc.), these are provided to the HA as appropriate. The HA notification decision is independent of any subsequent regulatory activities. All HA notifications worldwide are internally tracked using the same unique identifier/code, provided by the QPPV Office to enable end-to-end oversight, from receipt (input) until notification (output) at the country level. Results: The implementation of the streamlined process ensures global regulatory requirements (e.g., EU [1], UK [2], Switzerland [3], Saudi Arabia, [4], and Australia [5]), are met and the MAH provides consistent and concise signal information to all HAs. Conclusion: The active role of the QPPV Office and the re-defined global process has been demonstrated to be effective in providing timely and consistent safety information to HAs around the world.