Written by: Kelly Dannucci, Sr. Manager, Global Access, Medicines360/Impact RH360
Harmonizing pharmaceutical product labeling (i.e., using identical labeling across multiple countries) can create time and cost efficiencies that benefit stakeholders across the value chain. Despite the clear benefits, there is little publicly available information for manufacturers and suppliers who want to pursue harmonized labeling of their products.
Under the Learning about Expanded Access and Potential of the LNG-IUS (LEAP) Initiative, Impact RH360, WCG Cares, and FHI 360 developed a strategy to implement harmonized labeling for Impact RH360’s hormonal IUD, Avibela*. As part of this effort, the project team conducted extensive desk research on the labeling requirements issued by regulators in 21 low- and middle-income countries (LMICs) and conducted 12 interviews with subject matter experts (SMEs) and stakeholders from procurement agencies, donors, manufacturers of similar products, and independent global regulatory consultancies.
Key project findings include:
Harmonized labeling is preferred by both procurement agencies and manufacturers because it generally reduces lead time and cost.
While procurement agencies prefer multi-language labeling, other long-acting reversible contraceptives (LARCs) with single-language labeling have been procured in large volumes.
Some level of harmonization is possible for most LMICs assessed.
Approved harmonized labeling of similar products differs from guidelines published by national medicines regulatory authorities (NMRAs).
Manufacturers generally do not believe that there is an advantage to proactive engagement with NMRAs about labeling guidelines. Instead, a strong value proposition is required to advance regulatory approval of harmonized labeling; NMRAs are more willing to make allowances for products that are readily available, inexpensive, and respond to critical health needs.
World Health Organization (WHO) pre-qualification of a product is helpful, as NMRAs generally accept standard labeling that has been approved by the WHO.
Global contact information for pharmacovigilance (PV) reporting appears to be acceptable to NMRAs and procurement agencies, instead of providing local contact information.
Some country-specific requirements exist to reduce the risk of fraudulent or diverted product, which must be considered in harmonization efforts.
Achieving and maintaining harmonized labeling is complex and resource intensive, and “over harmonization” can result in diminishing returns.
These findings led Impact RH360 to develop a phased strategy for harmonized labeling for Avibela in order to benefit from some level of harmonization in the relative short-term (i.e., single-language labeling) while allowing adequate time to assess the more extensive changes that would be required for multi-language labeling (e.g., redesign of artwork and validation of new labeling sizes for some components).
One key component of the harmonized labeling strategy for Avibela was the creation of a webpage where Impact RH360 maintains current contact information for all local parties responsible for PV reporting in each country (i.e., distributors and local technical representatives) in addition to contact information for the local NMRA, where appropriate. The URL for this webpage is listed in the new harmonized package insert, along with a QR code that opens the URL upon being scanned by a smart phone. To our knowledge, the inclusion of a QR code for this purpose is a novel approach.
Across the countries where Avibela is currently registered, it is estimated that Impact RH360’s harmonization strategy would reduce the number of unique labeling components by half, from 16 to 8. Impact RH360 is actively implementing its harmonization strategy across existing Avibela registrations and upcoming submissions.
For questions, please contact Kelly Dannucci at kdannucci@medicines360.org.
The CTI Exchange will be are hosting a webinar on Harmonizing Product Labeling on March 22 at 10am EST in partnership with the Reproductive Health Supplies Coalition and the Hormonal IUD Access Group. Learn more and register here.
*Avibela is a registered trademark of Medicines360 in select LMICs.