Driving the harmonization of regulatory requirements – one country at a time
Regulations play a significant role in assessing marketing authorizations for drug products that are submitted for approval. Yet, regulatory agencies often differ in their degrees of harmonization. This has created an environment of divergence, in which countries each have unique standards, requirements, submissions and review processes.
The potential consequences of this situation can be seen in the context of the COVID-19 pandemic, where each vaccine developed has regulatory compliance issues related to different files, requirements and approval processes.
Despite recent progress – for example, some agencies have proactively changed their regulations to accept a ‘global dossier’ for COVID-19 products and are working closely with industry to ensure fast-track approvals – there is much work to do.
The complex global nature of biopharmaceuticals sometimes means that progress is not always as smooth as it could be. Industry and regulators should form a coordinated, streamlined process that delivers much-needed medicines around the world.
All of these issues, and more, are discussed in BioPhorum’s article The power of industry collaboration: driving harmonization of regulatory requirements. This outlines the strategy of its Regulatory Governance Team, which is a collaborative one working together towards a common goal of regulatory harmonization.
The pandemic has shown that swift changes can happen when all industry groups work together. The Team has a similar collaborative strategy for harmonizing what biomanufacturers write in their dossiers and working with different agencies so that their requirements are aligned with those in other countries.
Published in BioProcess International, the article also discusses three successful examples of BioPhorum’s approach to harmonization in China, Brazil and Russia (all three have been documented in free-to-download papers).
The case studies include hands-on, detailed reviews and recommendations so that agencies and biomanufacturers can work toward the common goal of harmonization. Doing this one country at a time within an overall framework is crucial to developing and implementing solutions that are tailored to each country’s needs.
BioPhorum imagines the future as a harmonized environment in which there is a high level of collaboration among regulatory agencies and industry, and digitization of data enables immediate decisions on product lifecycle management. It also looks ahead to where accelerated development is the norm and new therapies are implemented quickly and are compliant with standards – all on a global basis.
The Team aims to move the regulatory environment away from its current state of divergence. Successful global harmonization would lead to having one product, one globally accepted set of standards, one submission and one review process. That will take many years to achieve, but it would be transformative for the industry and patients worldwide.