Paula Barbosa
Associate Director, Vaccines Policy, IFPMA
Over the past few decades, the global regulatory environment has become more stringent and demanding to consistently guarantee the quality, safety and efficacy of medicines and vaccines.
The increase in requirements by regulatory authorities has not been implemented equally across the world. Nowadays, we have a high heterogeneity in terms of dossier review, approval processes and timelines, with each country having specific data requirements and processes which often differ between countries. As such, it is virtually impossible for every country in the world to have access to medicines and vaccines at the same time.
Regulatory requirements under COVID-19
Unfortunately, while vaccines are widely recognised as the most important tool to exit the COVID-19 pandemic, regulatory requirements have not been harmonised and simplified across the world to expedite access.
It has highlighted some weaknesses in the system, more precisely in the regulatory management for manufacturing and controls. For instance, the processes to validate, approve and recognise new manufacturing facilities, an essential step in scaling up vaccine production, are still not agile enough.
There are multiple changes in process that can happen after a vaccine is first approved, such as new types of fridges used or tests performed. We can see dozens of changes each year, which you need to multiply by the number of countries where the vaccines are approved, resulting in thousands of variation dossiers. This will become even more significant for COVID-19 vaccines as data will change at a faster pace than for regular vaccines.
The processes to validate, approve and recognise new manufacturing facilities, an essential step in scaling up vaccine production, are still not agile enough.
Several countries perform testing on vaccine batches which is redundant and time-consuming, and not always using the same test method and applying the same specifications. Initial COVID-19 vaccine batches have limited expiration dates. Therefore, redundant local testing reduces the remaining shelf life for a vaccine, potentially resulting in discarding expired doses.
The emergence of variants has led to the need to react quickly by developing, manufacturing, and approving new vaccines against those variants, for whom most of the above challenges will also apply.
The way forward
There are four areas which provide solutions for the regulatory concerns, which are:
1. Science and risk based approaches.
2. Global regulatory harmonisation.
3. Use of reliance, work-sharing, and recognition processes.
4. Digitalisation.
These solutions are not new and, whilst this pandemic has witnessed some progress at authority level, a lot needs to be done. Ultimately, quick and widespread access to medicines and vaccines is most important.