Value Added Medicines (VAM) Regulatory Expert

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Job Description

Short Term Consultant - Scope of Work

Position Title:

Component:

Export Unit

Reporting:

JCP Export Unit Director or Designee & JFDA Drug Registration Department Head

Period of Performance:

Jul 2017 – Mar 2018

Level of Effort (LOE): 6 LoE Onsite & 15 LoE Offsite (2 trips - 4 travel days)

Location:

Amman – Jordan

Background:

The USAID Jordan Competitiveness Program (JCP) works with policymakers, business associations, and the private sector to: 1) draft and advocate for enabling legislation and regulation; 2) leverage these policy interventions to stimulate exports and attract foreign direct investment, especially to Jordan’s specially designated development zones; and 3) ensure that these investments result in employment opportunities for Jordanians and, where appropriate, other residents of the Kingdom.

To these ends, JCP works closely with other USAID programs and relevant Government of Jordan entities to identify investment opportunities made possible by the Jordan Compact—which includes, among other stipulations, relaxed rules of origin for Jordanian exports to the European Union. By coordinating closely with the Compact’s Program Management Unit (PMU), which is housed at the Ministry of Planning and International Cooperation, JCP seeks to add value to the current efforts of the broader donor community.

The Jordanian pharmaceutical industry is considered as one of the pioneers and most competitive industry in the Arab countries. Pharmaceutical companies export 80 percent of their production to more than 60 countries worldwide, in addition to supplying 30 percent of all pharmaceuticals sold in the domestic market. The industry is primarily driven by branded generic exports.

The pharmaceutical industry is a backbone to the national economy, as it is the only Jordanian product with a positive trade balance In 2013, pharmaceuticals came in the first rank of Jordanian exports, representing 9 percent of total exports playing a pioneer and effective role at the macro-economic level. It strongly contributes to reducing the deficit in Jordan external trade balance. Human resources are the most important success factor in the pharmaceutical industry, and the Jordanian pharmaceutical industry has a well-established base in this field. The pharmaceutical industry hires well-educated employees; providing more than 11,000 jobs; it employs around 6500 directly in 20 pharmaceutical manufacturers (approx. 3.5% of the total workforce employed in Jordan’s industrial sector) with more than 5,000 additional employees working in supporting industries; nearly 40 percent of the sector’s workforce is female, approximately 99% of workers within the sector are Jordanians, of which more than 66% are highly skilled labor whose salary scale is high compared to other manufacturing industries in Jordan.

The pharmaceutical industry is a highly regulated industry. The “drug registration” in Jordan is the first step to move to export markets. Any pharmaceutical product has to be registered & priced by the regulatory authority to be approved for sale in the market. Jordanian Food and Drug Administration JFDA is the official body in charge of approving pharmaceutical products for sale in Jordan. There are multiple, long regulatory procedures that come before the drug registration and marketing, which requires supporting the Jordan Food and Drug Administration (JFDA) with the necessary experts and other resources to expedite drug registration process in Jordan, considering that every drug submitted to JFDA for registration is the result of a large investment of a given pharmaceutical company, and thus, represents a real opportunity for export and operation.

The USAID Jordan Competitiveness Program has continuously advised and played a consultative role in the Jordanian health care system by working closely with the Jordan Food & Drug Administration (JFDA) & the Jordanian Association of Pharmaceutical Manufacturers - JAPM, to develop and upgrade the pharmaceutical industry into world-class standards in order to become more competitive and increases their role in the global pharmaceutical market.

The growth of the pharmaceutical industry in Jordan highly depends on policy and regulatory reform that would lead to a regulatory environment that allows for the growth and expansion of pharmaceutical companies in Jordan. JCP will support JFDA in creating & identifying a clear regulatory pathway for Value-Added Medicines. This will help and support the pharmaceutical companies in Jordan to develop innovative products and depart from the conventional generic industry to a more promising future outlook. For this sake, a task force was formed which includes representatives from Jordan Food and Drug Administration (JFDA), the Jordanian Association of Pharmaceutical Manufacturers (JAPM) and representatives from the industry to focus on Value Added Medicines as a new horizon for the pharmaceutical industry in Jordan.

Objectives:

To develop regulations for the Value Added Medicines (VAM) including the Regulatory Guidelines that defines the regulatory requirements, a Scientific Advice system, an Industry Guide for preparation of VAM dossiers, an Evaluator Guide for review & evaluation of VAM dossiers and a Pricing Guidelines for the VAM. In addition, enhance the competencies of JFDA internal staff within the drug registration department on the review, assessment and evaluation of VAM dossiers.

Expected Results:

As a result of this project, we expect the following changes:

Issuance of VAM Regulatory Guidelines.
Enhanced competencies of JFDA internal staff in the implementation of the Value-Added regulation and review & assessment of VAM registration dossiers.
Enhance the pharmaceutical industry knowledge on the VAM requirements and their competencies in preparation of VAM registration dossiers that meet the regulatory requirements, addressing industry limitations and concerns in preparation of VAM registration dossiers.
Expedite the registration process of VAM through improving the quality of the registration dossiers, defining requirements of dossiers in general & module 5 in particular (clinical/BE studies) and highlighting acceptable degree of reliance on pre- clinical and clinical studies in originators’ dossiers or published data and minimizing deficiencies in registration dossiers.
Established Scientific Advice System in Jordan, to facilitate pre submission consultation advice from JFDA to the industry to guide the development process and minimize the waste of resources of the industry and JFDA.
Increased number of submissions and approved VAM.
Maintain sustainability of the pharmaceutical industry in Jordan moving to higher end products, giving it a competitive advantage in the region.
Issuance of Pricing Regulations for VAM; improving predictability of VAM prices in Jordan.

Eventually this would create more opportunities for the industry, moving into untapped investment areas, improve innovation climate in Jordan, enabling the industry to take better informed business decisions for investment in VAM development and production; bring JFDA at the forefront; having the first published guideline(s) for the VAM in the region.

For the sake of this SOW:

Value Added Medicines (VAM) represent a new form of R&D merging a pharmacological approach of well-known active substances with patients and/or healthcare professional insights, leveraging new technologies to transform existing molecules to address unmet needs and deliver relevant improvements for patients, healthcare professionals and/or payers. The added value may be achieved through a new indication for an existing drug (drug repositioning), improving the formulation (drug reformulation), developing a new dosage form or a new dose regime, developing a combined drug regimen or adding a new device (drug combination). The following is to further explain what can be considered as a Value Added Medicine; based on US FDA 505 B2 Guidance:

Dosage form: An application for a change of dosage form, such as a change from a solid oral dosage form to a transdermal patch that relies to some extent upon the authority finding of safety and/or effectiveness for an approved drug or any other oral forms that improve product compliance, adherence and bio availability such as buccal dosage form, oral films, etc.
Strength: An application for a change to a lower or higher strength.
Route of administration: An application for a change in the route of administration, such as a change from an intravenous to intrathecal route.
Substitution of an active ingredient in a combination product: An application for a change in one of the active ingredients of an approved combination product for another active ingredient that has or has not been previously approved.
Formulation: An application for a proposed drug product that contains a different quality or quantity of an excipient(s) than the listed drug where the studies required for approval are beyond those considered limited confirmatory studies.
Dosing regimen or different release profile: An application for a new dosing regimen, such as a change from twice daily to once daily.
Active ingredient: An application for a change in an active ingredient such as a different salt, ester, complex, chelate, clathrate, racemate, or enantiomer of an active ingredient in a listed drug containing the same active moiety, or polymorphism form.
New molecular entity (NME): In some cases a new molecular entity may have been studied by parties other than the applicant and published information may be pertinent to the new application. This is particularly likely if the NME is the pro-drug of an approved drug or the active metabolite of an approved drug. In some cases, data on a drug with similar pharmacologic effects could be considered critical to approval.
Fixed dose combination: An application for a new combination product in which the active ingredients have been previously approved individually.
Indication: An application for an indication which was not previously approved for a listed drug.
Naturally derived or recombinant active ingredient: An application for a drug product containing an active ingredient(s) derived from animal or botanical sources where clinical investigations are necessary to show that the active ingredient is the same as an active ingredient in a listed drug
Recombinant active ingredient: An application for a drug product containing an active ingredient(s) derived from recombinant technology where clinical investigations are necessary to show that the active ingredient is the same as an active ingredient in a listed drug.
A Drug Device Combination: is a product composed of any combination of a drug and a device or a biological product and a device.
Adding a device to improve drug intake for pediatrics or elderlies or to improve drug stability, or changing the originator’s device into a more convenient device that improves drug intake or stability of a chemical or biological product.
A biological conjugate is a drug and a biological product, or a drug, device and a biological product.
A combination product is defined to include:

A product comprised of two or more regulated components (i.e., drug/device) that are physically, chemically, or otherwise combined or mixed and produced as a single entity.
Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products.
A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where, upon approval of the proposed product, the labeling of the approved product would need to be changed (e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose); or
Any investigational drug, device or biological product packaged separately that according to its proposed labeling is intended for use only with another individually specified investigational drug or device or biological product where both are required to achieve the intended use, indication, or effect.[1]
A product with added material of vitamins, minerals or naturally derived material that is either within the recommended daily allowance or a traditional and well known herb.

Roles and Responsibility:

The consultant should:

Review the EMA, USFDA and the Health Canada Regulatory Guidelines for the Value Added Medicines. Provide those guidelines including the definitions for all sub categories of VAM, with references. (2 LoE – Offsite).
Provide real example (s) of product in each category listed in pages (3,4 & 5) of this scope approved by EMA, USFDA & regulatory authorities in reference countries recognized by Jordan, preferably with EMA PARs and any publically available assessment reports. (2 LoE- offsite).
Review the initial draft Regulatory Guidelines for the Value Added Medicines proposed by the task force, amend the draft based on the international regulations, provide a Proposed Regulatory Guidelines for VAM in Jordan. (2 LoE – Offsite). The proposed guidelines should highlight, but should not be limited to:
1. Type of information that the industry can rely on while developing VAM and JFDA can refer to and compare against while assessing, for the different sub categories under the Value Added Medicines (Published Literature, the safety and effectiveness for an already approved product, etc.).
2. Identify the Clinical or Bioequivalence studies necessary to support VAM applications; define cases where full safety and effectiveness studies may not be necessary if appropriate bridging studies can provide an adequate basis for reliance, based on JFDA’s findings of safety and efficacy of a previously approved product, similar to Annex II of EMA guidelines for BE requirements for Hybrid products.
Provide pricing guidelines for Value Added Medicines & pricing practices in the list of “Reference Countries for Pricing in Jordan” & propose a Pricing Guidelines for VAM in Jordan (1 LoE – Offsite)
Present the amended Regulatory Guidelines and the proposed Pricing Guidelines to the task force, discuss and collect feedback & comments. (1 LoE – Onsite)
Amend the two proposed guidelines based on the collected feedback & share the final proposals with JCP & the task force for final review. (2 LoE – Offsite)
Develop the Industry Guide to prepare VAM registration dossiers including a detailed checklist for the regulatory requirements. (1 LoE- offsite)
Develop the Evaluator Guide for the assessment of the of Value Added Medicines registration dossiers by JFDA; including SOPs & assessment template(s) to support the assessors (2 LoE – Offsite)
Propose a Scientific Advice System in Jordan based on international best practices and systems, to facilitate pre submission consultation advice from JFDA to the industry to guide the development process and minimize the waste of human and financial resources at industry and regulator’s sides. (1 LoE- offsite)
Deliver two workshops for JFDA staff and the industry – 2 day each, one day is joint and one day is separate- on the regulatory requirements for and assessment criteria of VAM registration dossiers. Development of the workshop material and presentations is the consultant’s responsibility. (2 LoE – Offsite & 4 LoE – Onsite).
Prepare a final report to USAID JCP and JFDA and end of mission report (1 LoE – Onsite)

Minimum Qualifications:

Healthcare background with a PhD degree in Pharmacy or related fields.
Current or previous assessor at EMA, USFDA or a highly recognized drug regulatory authority.
Minimum of 5-year experience in Value Added Medicine Regulatory and Practical Experience.
Expertise & Practical experience in pharmaceutical formulation and development of value added medicines is desirable.
Knowledge of electronic Common Technical Document (eCTD) is a plus.
Demonstrate a track record of developing, delivering and managing consultancy assignments.
Capable of conducting training on the preparation & assessment of the Value Added Medicines registration dossiers with proven track record.
Strong interpersonal, communication and problem-solving skills.
Excellent command of English (both written and verbal).

Deliverables Schedule:

Deliverable 1: Proposed Regulatory Guidelines for VAM
Deliverable 2: Proposed Pricing Guidelines for VAM
Deliverable 3: Industry Guide to prepare VAM registration dossiers including a detailed checklist for the regulatory requirements.
Deliverable 4: Evaluator Guide for the assessment of the of Value Added Medicines registration dossiers by JFDA; including SOPs & assessment template(s)
Deliverable 5: Provide a proposal for Scientific Advice System in Jordan.
Deliverable 6: Two 2-day workshops delivered and all material and ppt. prepared and distributed.
Deliverable 7: A de-briefing presentation for USAID Jordan Competitiveness Program (JCP) leadership and USAID Economic Growth Office (EGO) staff that focuses on major outcomes.
Deliverable 8: USAID-Mandated End of Mission Report summarizing and justifying all findings, assessment results and recommendations.
Deliverable 9: Identify and submit any resources (tools), in the technical area in which you’re working, that could benefit the understanding of best-practices and/or the reform efforts of the Jordanian organization(s) that are the primary focus of your consultancy. This could include templates, case studies, presentations, web links, white papers, online newsletters, assessments or checklists, etc. Please make note of any resources that may be subject to copyright or usage restrictions.

Deliverable #

Details

Due Date

Delivery Terms

Deliverable 1

Report on desk research for international Regulatory Guidelines for Value Added Medicines, with definitions and examples & publically available assessment reports.

Proposed Regulatory Guidelines for Value Added Medicines in Jordan.