Deadline: 2-Sep-25
The European Commission is accepting project proposals to support the Egyptian Drug Authority (EDA) to reach WHO Global Benchmarking Tool (GBT) Maturity Level 4 for Medicinal Products, including vaccines, and to comply with WHO Good Regulatory Practices up to the level of a Stringent Regulatory Authority (SRA).
The overall objective is to improve the enabling regulatory environment for medicinal products including vaccines in Egypt and promote Egyptian Drug Authority to become a World Health Organisation (WHO) – listed Authority (WLA).
Components
- To achieve the overall objectives, the twinning partners will engage with EDA on the following aspect but not limited to:
- Improvement of the national regulatory system in line with good regulatory practices and international standards;
- Marketing authorisation for medicinal products, including vaccines and life cycle management (renewals and variations);
- Import, Manufacturing and Wholesale distributor authorisation.
- Regulatory inspections, specifically Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) for medicinal products, including vaccines;
- Quality control testing of medicinal products, including vaccines;
- Official batch release for specific medicinal products such as vaccines;
- Post-marketing surveillance and pharmacovigilance, including support for a pharmacovigilance center;
- Oversight of clinical research/trials, including testing of vaccines.
Funding Information
- Grant Amount: EUR 1,500,000
- Maximum project duration: Execution period of the project shall be 27 months (24 months of implementation + 3 months closure period).
Geographical Area
- Arab Republic of Egypt
Who may apply?
- Only Public Administrations and Mandated bodies as per Twinning Manual of European Union Member State may apply through European Union Member States National Contact Points.
- The project will be implemented in the form of a Twinning between the Beneficiary Country and EU Member State(s). The implementation of the project requires one Project Leader (PL) with responsibility for the overall coordination of project activities and one Resident Twinning Adviser (RTA) to manage the implementation of project activities, Component Leaders (CL) and a pool of short-term experts within the limits of the budget. It is essential that the team has sufficiently broad expertise to cover all areas included in the project description.
- Profile of the PL:
- Basic Skill Requirements:
- University degree in public health, health economics, pharmacy, epidemiology, international health, or other relevant discipline
- Professional experience of 10years in pharmaceutical regulatory, public health or other sectors relevant to this twinning;
- Minimum 3 years of specific experience, at a senior management level, in human medicines- related regulatory functions in EU MS relevant national administrations;
- Very good spoken and written English (at least level 2 on a scale of 1 [excellent] to 5 [basic]).
- Assets:
- Experience in EU-funded project management, preferably twinning;
- Specific professional experience in vaccine regulatory oversight.
- Basic Skill Requirements:
- Profile of the RTA:
- Basic skill requirements:
- University degree in health economics, public health, or other relevant discipline (such as physician, pharmacist, regulator, ..) or equivalent professional experience of 8 years in the public health sector;
- Minimum 3 years of specific experience in human medicines-related regulatory functions in EU MS relevant national administrations;
- Very good spoken and written English (at least level 2 on a scale of 1 [excellent] to 5 [basic]).
- Assets:
- Experience in project management, preferably twinning;
- Experience in implementation of relevant EU legislation and EU instruments related to the project components.
- Basic skill requirements:
- Profile of Component Leaders:
- Basic skill requirements
- University degree in relevant discipline or equivalent professional experience of 8 years in a sector relevant to the component of the twinning for which the candidate is proposed;
- Minimum 3 years of professional experience at an operational level in relevant EU MS health administration or mandated body in a field relevant to the component for which the candidate is proposed;
- Very good spoken and written English (at least level 2 on a scale of 1 [excellent] to 5 [basic]).
- Assets:
- Experience in capacity building and, ideally twinning projects
- Basic skill requirements
- Profile of other short-term experts:
- Basic Skill Requirements:
- University degree or equivalent professional experience of 8 years;
- At least 3 years of professional experience as an expert in a respective field related to the purpose of the mission foreseen in the work plan;
- Very good spoken and written English (at least level 2 on a scale of 1 [excellent] to 5 [basic]).
- Assets:
- Experience in delivering capacity building activities;
- Experience in providing inputs to policy/regulatory documents, methodological guides and/or handbooks.
- Basic Skill Requirements:
- Profile of the PL:
Language
- The official language of the project is the one used as contract language under the instrument (English). All formal communications regarding the project, including interim and final reports, shall be produced in the language of the contract.
For more information, visit EC.