A goal of this toolkit is to stimulate conversations between government, partners, and communities on new product introduction. Please feel free to share any thoughts, questions, or additional resources for consideration by contacting us via email at any time: HIVToolkit@clintonhealthaccess.org.

Copyright © 2017

Registration

Ensuring all new products are registered for use in-country

In order for products to be used in national programs, they must comply with national or donor regulatory requirements. While suppliers take responsibility for submitting dossiers for product registration, processes can often be subject to bottlenecks that cause delays in access to new products. National treatment programs and partners may be able to assist with communication and addressing challenges in the regulatory process.

Registration Checklist

Ensure suppliers have filed dossiers with the National Drug Regulatory Authority (NDRA) to register new ARV products 
 

Monitor registration status and progress with NDRAs 
 

When appropriate, apply for a registration waiver or expedited review process while national registration is pending 
 

Ensure the new product is included in the country’s essential medicines list and standard treatment guidelines, where applicable 
 

Support Ministry of Health (MoH) and NDRA collaboration to communicate public health priorities and address common registration bottlenecks (as outlined in the HIV New Product Introduction Guidebook)

Use the links below to download the entire HIV New Product Introduction Guide 
or the Registration chapter only

Registration Tools and Resources

MoHs and implementing partners should monitor product development timelines and dossier submissions for products required for use in the national program, Stringent Regulatory Authority (SRA) approvals, and product registrations with National Drug Regulatory Authorities (NDRAs). Clear communication of national program priorities to NDRAs can help NDRAs to prioritize the many dossiers they receive to accelerate review and registration of those products which offer the greatest public health benefits. In addition to NDRA registration, program implementers should also ensure that the product is included in the country's essential medicines list if that is a requirement for importation.  This section outlines resources that can be useful in the product registration process. 

Featured Resource: New Product Development Timelines

Having a clear view of upcoming regulatory submissions allows countries to monitor dossier submissions to NDRAs and plan introduction based on expected product availability.  This resource shows the latest understanding of targeted regulatory filings for key ARVs. Please note that these timelines  are very dynamic and can change from month-to-month. This resource will be updated as information of timelines changes. Another resource for reference is a slide deck on "Drug Development 101" that provides a high-level overview of the drug development process:

Last Updated: August 2017

 

Stringent Regulatory Authority (SRA) Approval

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Stringent Regulatory Authority (SRA) is a medicines regulatory authority that enforces and ensures medicines developed by manufacturers and suppliers are up to international standards. Some donors require specific SRA approvals to be in place before products can be procured (e.g. Procurement from U.S. President's Emergency Plan for AIDS Relief (PEPFAR) requires approval from the United States Food and Drug Administration (FDA)).  This database can be referenced for information on all current SRA approved products across suppliers:

 

WHO Prequalification Program (WHO PQ) and Expert Review Panel

WHO Prequalification Program (WHO PQ) and Expert Review Panel

The WHO Prequalification of Medicines Programme (WHO PQ) helps ensure that medicines supplied by procurement agencies meet acceptable standards of quality, safety, and efficacy.  WHO maintains a list of Prequalified products on their website accessible here.  Please note that while WHO PQ is not a Stringent Regulatory Authority, products with WHO PQ are also listed in the CHAI SRA approval database above.

The Expert Review Panel (ERP) is an independent body of technical experts hosted by the WHO’s Quality and Safety of Medicines Department. This information note provides a high-level overview of the ERP, including the program’s basic principles, eligibility criteria, and dossier review process.

Resources:

The WHO Prequalification of Medicines Programme (WHO PQ) helps ensure that medicines supplied by procurement agencies meet acceptable standards of quality, safety, and efficacy.  WHO maintains a list of Prequalified products on their website accessible here.  Please note that while WHO PQ is not a Stringent Regulatory Authority, products with WHO PQ are also listed in the CHAI SRA approval database above.

The Expert Review Panel (ERP) is an independent body of technical experts hosted by the WHO’s Quality and Safety of Medicines Department. This information note provides a high-level overview of the ERP, including the program’s basic principles, eligibility criteria, and dossier review process.

Resources:

 

National Drug Regulatory Authorities (NDRAs)

National Drug Regulatory Authorities (NDRAs) are mandated to ensure that all medicines and medical devices used in country are safe, effective, and of high quality. It is important to ensure that the drug is registered in-country through an NDRA. It may be possible to obtain an import waiver to enable importation of SRA approved products prior to NDRA review and approval to avoid delays in patient access to new products.  This document outlines an illustrative process and requirements for national programs to request a waiver to make products accessible while national registration is underway:

 

Global Fund Sourcing and Management of Health Products

This section of the Global Fund website provides updates on ARVs found to be quality assured, including by the Expert Review Panel, as well as updates on any quality assurance issues or changes to procurement guidance: