The regulatory affairs team is critical to CEPI’s mission and has two key components:
- Provide regulatory support and oversight to our funded programmes, ensuring that developers have built regulatory strategies that will meet the programme’s objectives and ultimately achieve regulatory approvals;
- Shape the regulatory environment by engaging with regulators worldwide, identifying regulatory challenges and bottlenecks; building solutions and driving the regulatory community to alignment.
The regulatory function will work across multiple workstreams in connection with CEPI 2.0 as well as identify opportunities for accelerating vaccine development and working with local and regional regulators to ensure greater epidemic preparedness.
Practical strengthening of regulatory and ethics oversight on clinical trials in West Africa using Lassa Fever vaccine development projects and increase regulatory maturity level in targeted countries
This project (101103241 — ECOWAS-RegECs), which is directed to the Economic Community of West African States (ECOWAS) Member States, is coordinated by CEPI and Funded by the European Union under the Global Health EDCTP3 Joint Undertaking. With CEPI acting as a Project Coordinator, the implementing partners are Food and Drugs Authority, Ghana (G-FDA), West African Health Organization (WAHO), and the Paul Ehrlich Institut (PEI).
The first main objective of the project is to improve the capabilities of Regulators and Ethics Experts in vaccines clinical research oversight, with initial focus on the early stages of vaccine development. For this objective the African Vaccine Regulatory Forum (AVAREF) will be a key partner as we intend to conduct simulations and observations of the AVAREF joint procedures. More specifically, the project team prepares simulation and observation modules making use of applications of Lassa Fever vaccine developers and running them through the AVAREF platform. This will strengthen the ECOWAS Regulators’ and Ethics Experts’ ability to provide scientific advice and assess clinical trial dossiers based on risk-benefit analysis in joint procedures. By exposing National Regulatory Authorities (NRAs) and Ethics Committees (ECs) to the assessment of Lassa Fever vaccines during the vaccine’s development cycle, the project aims to prepare them for licensure and for the case of a possible need for emergency use approval.
This work will promote collaboration between NRAs, ECs and AVAREF for efficient and reliable management of clinical research in West Africa and aims to create a Lassa disease-related regulatory and ethics network.
The second main objective of the project is to enhance the Maturity Level of selected ECOWAS NRAs by focused support through FDA Ghana on regulatory systems and clinical trial oversight. The WHO Global Benchmarking Tool (GBT) indicators for regulatory systems and clinical trial functions will be used to map the status of ECOWAS countries and develop a strengthening plan for the region.
For further details, please follow the weblink: https://www.ecowasregecsproject.com/about
Expanding Master Files for human medicinal products in the EU/EEA
CEPI and EFPIA collaborated to author a regulatory position paper on master files in the EU. A new “Pharmaceutical Master File” overarching model is proposed that encompasses existing master files procedures as well as expanded approaches not in place today. The flexible and modular Pharmaceutical Master File aims at enabling faster access to novel medicines, including vaccines.