Regulatory affairs teams are expected to manage global expansions and bring trusted products to market faster while also navigating the complexities of keeping existing products on the shelf.
Achieving market access for a new product reference is one of the key use cases we at Veeva see regulatory affairs teams struggle with. But did you know that more than 50% of a product portfolio is made of product variations?
When new products are planned to be sold in a market, the teams must search through potentially hundreds, or even thousands, of existing active registrations that the company holds in order to determine if that product can be registered under an existing active registration.
A recent Veeva survey highlighted that existing product maintenance was the biggest regulatory challenge for 45% of regulatory affairs professionals, and almost 50% cited brand maintenance as a source of increasing workload and stress.
3 Principles for Streamlining Product Registration Reviews
It’s not an easy task to understand the local impacts among a myriad of product registrations. Product changes are legion and of different magnitude (change of formula, change of product name, change of packaging, change of claims, etc…), which do not always trigger a reformulation but always raise questions around whether there’s a need to amend the registration.
How can regulatory affairs streamline internal registration review and reduce time to market? Here are three principles we see market leaders adopting in their regulatory transformation strategies:
Aggregate All Registration Content on a Single Platform
When a new product registration is expected, regulatory affairs teams must lean on critical registration data (location, Formula, Product Name, Pack Size, Made in, etc…) to perform a regulated category assessment. By populating key product data on a unified product registration management software, regulatory affairs can easily find existing registrations for which data matched with the new product registration request and quickly assess if any registration can be reused, saving countless hours of manual searching.
Institutionalize the Knowledge
Due to the varying regulatory requirements across countries and regions, the task of determining the impacts on existing product registrations is typically a time-consuming, highly manual process. By defining for each type of registration the factors to assess if the registration can be reused, as well as their impact, regulatory affairs can focus on strategic work to meet evolving customer needs.
Leverage Automation for Registration Requirements
Once the content and data is consolidated, we’ve seen companies committed to digitizing regulatory compliance move ahead to link existing registrations to new product registration requests. Want to know what pending requirements regulatory affairs need to fulfill before registration can be completed? Automation capabilities like those found in RegulatoryOne can help teams to identify the requirements for each product registration, quickly collect missing documents to complete the registration, and increase overall efficiency and visibility.
Update Product Registrations Faster and with Confidence
Local impact assessment capabilities allow regulatory affairs teams to have reliable data and content at their fingertips to assess registration updates confidently and keep existing products on track.
By giving regulatory affairs teams the tools to bring trusted products to market faster, regulatory affairs can better support company goals for global expansion into new product categories and markets.
To learn how Veeva can help you implement a world-class registration management process at your organization, contact us to talk with an expert.