When weighing post-approval changes, many health authorities go it alone
Post-approval changes, whether to product information, manufacturing processes or dosing and administration, are a routine part of lifecycle management for life science companies. However, a lack of consistency in country-by-country classification systems, data requirements and processes makes managing these changes a sometimes dauting endeavor for pharmas and biotechs operating in multiple global markets.
Clarivate recently partnered with the IFPMA on a study looking at how different countries and regions regulate post approval changes (PACs) and how closely they align with the World Health Organization guidelines. The study found some alignment among the countries studied – and a lot of room for improvement. We unpacked the findings in a recent webinar, Addressing global challenges of inconsistent classification systems.
In the webinar, Clarivate Director of Regulatory and Clinical Consulting Regina Galera outlined some of the challenges for companies working across markets, which include inconsistent classification systems, data requirements and processes, resulting in unpredictable approval timelines and extended implementation periods post-approval.
“There are multiple consequences to this,” said Galera, “from duplicated efforts by both industry and regulators to divergent interpretation and decisions by health authorities in different markets. The end result is extended review timelines, larger backlogs and staggered submission planning and approval times. These repercussions can prevent companies from focusing on critical or major changes related to safety and efficacy.”
Dr. Karim Kacimi, Senior Specialist for Global Regulatory Affairs, Policy and Intelligence at Novo Nordisk, said the fragmented global regulatory landscape places a significant administrative burden on companies and requires time-consuming documentation and coordination. He noted that one of the survey’s findings was that many health authorities do not fully utilize reliance mechanisms that could reduce redundancy and streamline the management of PACs.
“To streamline the management of PACs, an immediate action could be to unleash the power of reliance,” said Kacimi. “It would reduce redundancy and spare health authority resources to focus on the most critical tasks.”
The IFPMA/Clarivate study, which utilized Clarivate Cortellis CMC Intelligence data, found that just 43% of the 21 countries studied had reliance for PACs, meaning that they referenced competent authorities and international organizations (e.g., FDA, EMA, PMDA) in weighing approvals of PACs.
Among the other key recommendations of the study were:
- Global regulatory convergence via a science- and risk-based regulatory framework to enable more efficient management of PACs
- Implementation of national or regional variation guidelines in accordance with international standards such as the European Medicines Agency’s ICH Q12 guidelines or the World Health Organization’s Guidelines on changes to biotherapeutic products in order to allow consistency in handling of changes without the need for additional local requirements
- Expanding reliance practices to include life cycle management in order to speed approval of changes and facilitate patient access to innovative, safe and efficacious treatments.
You can download the study here, and you can view the webinar here. Learn more about how Clarivate helps companies ensure compliance in global markets using Cortellis CMC Intelligence.
