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1. Purpose of consultancy
The purpose of this consultancy is to review the legal provisions of the Jordan Food and Drug Administration (JFDA) related to the WHO Global Benchmarking Tool (GBT) for medicines and vaccines. The consultant will work closely with JFDA and WHO to reflect all required legislative amendments based on the Institutional Development Plan (IDP) review and WHO recommendations, to ensure full compliance with the legal requirements needed to achieve an advanced maturity level according to the WHO GBT. This includes reviewing, drafting, and following up on all necessary legislative amendments.
2. Background
The World Health Organization (WHO) plays a pivotal role in supporting countries in strengthening their regulatory systems and promoting equitable access to quality, safety, efficacy, and affordable medical products and health products. The WHO constitution affirms that enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being. Towards the achievement of such a noble objective, the WHO constitution states the functions of WHO, which include among others, assisting governments, upon request, in strengthening health services. Various world health assembly (WHA) resolutions encompass aspects of the need to promote the WHO role. It should be noted that regulators are an essential part of the health workforce and effective regulatory systems are an essential component of health systems and contribute to better public health outcomes. On the contrary, inefficient regulatory systems themselves can be a barrier to accessing safe, effective and quality medical products.
WHO mandated by resolution WHA 67.20, supports countries to strengthen regulatory systems by:
• building regulatory capacity in member states consistent with good regulatory practices, and
• promoting regulatory cooperation, convergence and transparency through networking, work-sharing, and reliance.
Benchmarking activities involve the evaluation of the medical products’ national regulatory system using the WHO Global Benchmarking Tool (GBT), generating and analyzing evidence of regulatory systems performance and facilitating the formulation of Institutional Development Plans (IDPs) as a set of recommendations for the National Regulatory Authorities (NRAs) of member states.
3. Work to be performed
Specific Objectives
Objective 1: Map all required legislative and regulatory amendments needed to align with the WHO Global Benchmarking Tool (GBT) requirements.
Objective 2: Based on the review of the JFDA Benchmarking Institutional Development Plan (IDP) and WHO recommendations, propose the necessary adjustments in accordance with Jordan’s legal and regulatory framework, ensuring full alignment and avoiding any inconsistencies or contradictions between existing provisions.
Objective 3: Submit the final consolidated version of all required legal provisions and amendments, fully ready for JFDA to present to the Government of Jordan through the appropriate official channels.
Deliverable 1: Prepare a methodological note outlining the proposed approach for providing legal support to the JFDA.
Deliverable 2: Review all existing legal provisions of the JFDA related to the WHO Global Benchmarking Tool (GBT) for medicines and vaccines— including relevant laws, bylaws, regulations, instructions, guidelines, and policies —based on the Institutional Development Plan (IDP) review, WHO recommendations, and international best practices, to ensure full compliance with the legal requirements for achieving an advanced maturity level under the WHO GBT.
Examples of existing legal provisions to be reviewed include, but are not limited to:
· Instructions for Implementing the Principles of Good Clinical Trial Practice and Laboratory Tests Related to Pharmaceutical Studies, 2024
· Clinical Trials Law, No. 2 of 2011
· Jordan Food and Drug Administration (JFDA) Law, No. 41 of 2008
· Drug and Pharmacy Law, No. 12 of 2013
· Additional relevant bylaws, regulations, instructions, guidelines, and policies
Deliverable 3: Draft and amend all required legal articles and statements for the necessary legal provisions, in close coordination with JFDA and WHO.
Deliverable 4: Submit the final consolidated version of all required legal provisions and amendments, fully ready for submission by JFDA to the Government of Jordan through the appropriate official channels.
Deliverable 5: Provide legal support and assistance to JFDA throughout the official approval pathway, as requested by the JFDA Director-General. This may include engagement with the Legislation and Opinion Bureau, the Prime Ministry, the House of Representatives, and the Jordanian Senate, as required.
Deliverable 6: Submit a final comprehensive report on the progress, outcomes, and implementation of all legal support provided, including all legislative amendments developed for JFDA.
4. Qualifications, experience, skills and languages
Educational Qualifications:
Essential: First University degree in Law from a recognized and accredited academic institution.
Desirable: Advanced University degree in International Business, Business Administration, or Quality Management Systems.
Experience:
Essential:
A minimum of 5 years of relevant professional experience in Jordanian legal provisions and legislative amendment processes.
Well-established knowledge of Jordan’s legal framework, legislative requirements, and approval pathways.
Desirable:
Previous experience working with the key national legal entities in Jordan, including the Legislation and Opinion Bureau, the Prime Ministry, the House of Representatives, and the Jordanian Senate.
A minimum of 5 years of experience in reviewing, drafting, and following up on legislative amendments.
Extensive experience in delivering similar international consultancies, with demonstrated and measurable results.
Skills/Technical skills and knowledge:
· Excellent communication skills and proven ability to work effectively in diverse cultural, institutional settings, and managing multiple tasks simultaneously with timely delivery.
· Advanced computer literacy, including proficiency in regulatory IT systems and databases.
· High-level drafting, analytical, and interpersonal skills, with the ability to convey complex concepts clearly.
· Report-writing skills.