Regulatory requirements for product registration can be overwhelming. They’re complex, vary by country, and frequently change. We know they’re important (safe medicines, yes!), but what does it actually take to get a product from the manufacturing plant onto the shelves in your local pharmacy? Let’s take a look together.
LACTIN-V is being registered in South Africa for use in the FRESH clinical study. FRESH follows young women at risk for HIV and, among other objectives, regularly checks the parameters of their vaginal microbiome. Many women in the study have microbiota depleted of normal Lactobacillus strains, which leaves them vulnerable to infections, including HIV. One arm of the study hopes to show that LACTIN-V could decrease genital tract inflammation and lower their HIV acquisition risk.
Catalyst Global’s regulatory support includes regulatory planning, facilitation of the pre-registration (Type C) meeting with the South African regulatory authority, preparation and submission of the clinical trial application to the regulatory authority and the ethics committees, and subsequent protocol amendment submission and ongoing support.
Our team communicates with the regulatory authority and the ethics committees throughout the study to facilitate the finalization of the regulatory processes needed prior to clinical trial initiation. We also provide assistance for the submission and renewal of clinical trial insurance, including reviewing drafts of study documents such as the protocol and informed consent to ensure compliance with requirements and communicating with the sponsor, UCSF.
2017 – 2022
University of California, San Francisco (UCSF)
Biotherapeutic product aimed at reducing HIV transmission (LACTIN-V)
“As an academic researcher from the US with limited expertise in navigating global drug regulatory pathways, the excellent guidance by WCG’s team (now Catalyst Global) was foundational for the planning and implementation of our clinical study in South Africa. It is critical to have local regulatory experts on your team, even more so when a global pandemic is slowing everything down.”
Anke Hemmerling, MD PhD MPH, Professor,
Department of Obstetrics, Gynecology & Reproductive Sciences; UCSF
The Product Registration Toolkit is a digital collection of adaptable resources to guide the process of registering health products, like contraceptives, in low- and middle-income countries.
The goal of the Market Access Accelerator is to support commercial partners to bring new, innovative sexual and reproductive health products to market in low- and middle-income countries.