WHO collaborative registration procedure using stringent regulatory authorities’ medicine evaluation: reliance in action?

ABSTRACT

Introduction

The regulatory approval of medical products in countries with limited regulatory resources can be lengthy, which often compromises patients’ timely access to much-needed medicines. To improve the efficiency of regulatory systems, reliance is being used. Reliance allows an authority to leverage the work performed by other authorities, such as scientific evaluations, to decide on medical products approval within their jurisdiction. This reduces duplication of regulatory efforts, resources and time, while maintaining national sovereignty.

Areas covered

This article analyzes the outcomes and stakeholders’ experience of using medicines assessments performed by Stringent Regulatory Authorities (SRA) in the Collaborative Registration Procedures (CRP). Since its establishment in 2015, 59 approvals were granted to 16 medicines in 23 countries through SRA CRP. Results show that the procedure is delivering on the intended benefits of access and speed, with long-term positive impact for resource-limited countries. The article concludes with recommendations on the need for guidance on management of post-approval changes, wider promotion of the procedure, and increased collaboration between authorities.

Expert opinion

The SRA CRP provides a mechanism for the use of reliance by strengthening communication and promoting the exchange of information among regulators. This fosters faster regulatory approvals and, consequently, earlier access to medicines.

KEYWORDS:

• Reliance
• global health
• patient access
• WHO
• marketing authorization
• medicines
• international collaboration
• regulatory authorities

Article highlights

• The SRA CRP is a regulatory procedure that aims to facilitate and accelerate the regulatory approval of quality-assured, safe and effective medicines, relying on the expertise of SRAs.

• Reliance enables a regulatory authority to use assessments performed by other regulatory authorities while remaining accountable for the final decision.

• The evaluation of the SRA CRP pilot showed that this procedure improves the efficiency of regulatory processes, expediting the regulatory approval of medicines.

• Given the benefits of the SRA CRP, more regulatory authorities and pharmaceutical companies should consider participating in this procedure.

• The use of the SRA CRP contributes to the ultimate goal of facilitating earlier access to medicines for patients worldwide, improving global public health.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Disclaimer

The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agency or organization with which the authors are employed.

Additional information

Funding

This paper was not funded.