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Overwhelmed by Health Product Registration? We’re Here to Help!

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.

The USAID-funded Expanding Effective Contraceptive Options (EECO) project, led by Catalyst Global, developed the Product Registration Toolkit. It helps guide regulatory experts and non-experts alike through the process of registering health products, like contraceptives, in low- and middle-income countries (LMICs). The digital collection of adaptable resources includes:

  • An introductory video.
  • A primer on product registration basics.
  • A selection of checklists, templates, and decision trees. 

Each will help you navigate the process of product registration from start to finish.

Check out the two-minute overview of the toolkit below.

Preparing for product registration is a daunting task, but we’re here to help. The Product Registration Toolkit is a tour of the inner workings of the process. You’ll get a glimpse of each step along the way and leave with adaptable tools to support your own registration in an LMIC.

Take a peek at what you’ll find inside the Product Registration Toolkit:

  1. Primer on product registration basics. The goal of this guide is to demystify regulatory affairs for non-experts. Readers will learn the basics of product registration and how this information can support good decision-making by program managers in consultation with regulatory experts. 
  2. Checklists to guide the registration process. Managing the many processes involved in product registration requires constant juggling. Use this series of checklists to help you stay organized and plan ahead.
  3. Templates of common documents required for product registration. While each registration application is slightly different, there are some standard documents required for most applications. Use these templates to jumpstart the process.
  4. Quick reference glossary. Confused by all the regulatory jargon? This glossary is a one-stop shop for definitions of frequently used terms in regulatory work.

You can find the full toolkit, with downloadable copies of the resources, here.

For any questions or inquiries regarding EECO’s Product Registration Toolkit, please reach out to Shannon Bledsoe.

EECO Product Registration Toolkit Image
Courtney Stachowski

Program Manager, Catalyst Global

Courtney Stachowski is a Program Manager with over 10 years of experience in public health and reproductive health. She currently serves as a Program Manager at Catalyst Global (formerly WCG Cares), managing its portfolio of regulatory affairs activities. Prior to joining Catalyst Global in 2016, Courtney earned her Masters in Public Health at Emory University and worked in various research capacities at Dartmouth College, Brigham and Women’s Hospital, and Johns Hopkins University.

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