Overwhelmed with 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.

By: Courtney Stachowski

The USAID-funded Expanding Effective Contraceptive Options (EECO) project, led by Catalyst Global, developed a Product Registration Toolkit to help 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, and a selection of checklists, templates, and decision trees to help you navigate the product registration process from start to finish.

Check out the 2-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 through the inner workings of the process. You’ll get a glimpse of each step along the way, from start to finish, and will 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 registrations: 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 ([email protected]).

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