During the pandemic, national regulatory authorities (NRAs) and the biopharmaceutical industry agreed on regulatory agilities which facilitated the much-needed rapid increase in manufacturing capacity without compromising quality, safety and efficacy of products. 

IFPMA has efforts in identifying regulatory agilities used during the pandemic and learnings from this unique experience to improve pandemic preparedness and enhance standard regulatory processes. We reviewed 36 international publications and surveys and conducted interviews with four participants from member associations in Africa, Asia, Latin America and the USA. As a result, we published a manuscript , policy briefings and recommendations for three common areas where agilities were applied: regulatory processes, quality and supply, and clinical trials.

Facilitating inspections 

The pandemic forced stakeholders to change working practices, which was particularly evident in conduct of Good Manufacturing Practices (GMP) inspections. Travel restrictions hindered on-site inspections, and the industry had to find alternative means to guarantee compliance with regulations.  

Leveraging digital tools proved to be successful in this regard, allowing for remote and hybrid inspections. The benefits were multifold: physical presence of the inspecting agency was not required, personnel could be in different locations, and inspections could be conducted across non-consecutive days. Such inspection methods also presented some challenges and will certainly be optimized as they  become more integrated in standard regulatory practice. Based on experience to date, industry has outlined a series of points to consider for the conduct of virtual GMP inspections.  

To increase inspection efficiency, some NRAs used reliance, for instance considering inspection reports by other agencies via mutual recognition agreements. Waivers to inspections were also granted if memorandums of understanding between countries were in place, or if the pharmaceutical inspection authority was participating in the Pharmaceutical Inspection Co-operation Scheme (PIC/S), an international organisation which works to improve co-operation and harmonisation in the field of Good Manufacturing Practices. 

Risk-based approaches to evidence management 

NRAs were aware that making timely decisions and working efficiently was imperative during the emergency. Risk-based approaches were thus adopted during decision-making, such as accelerated processes for GMP certification. 

Due to the swift development of COVID-19 medicinal products, expedited review processes and the need to open additional manufacturing sites, numerous post-approval changes (PACs) were put in place to enhance manufacturing processes and maintain supply. NRAs applied risk-based approaches to Chemistry, Manufacturing, and Controls changes, such as concurrent process validation, a commitment to submit some information post-approval, or derogations from labelling requirements. These agilities supported the unprecedented manufacturing output of vaccines and therapeutics during the pandemic.  

What can we learn for the future? 

In case of a future pandemic, NRAs should agree on more streamlined global evidence requirements for maintaining quality of medicinal products to facilitate harmonisation and predictability.  

NRAs should leverage risk-based approaches to evidence management, such as accelerated processes for GMP certification and real-time data review.  

To speed up inspections, virtual tools such as remote livestreaming video and screen sharing should be utilised and integrated as tools NRAs have at their disposal to optimize the inspection process. Furthermore, reliance should be maximised to increase efficiency as much as possible, for instance by reviewing inspection reports by other agencies. 

Standard manufacturing and supply processes can also become leaner.  

The COVID-19 pandemic highlights the importance of having a solid and diverse global supply chain to avoid disruptions at all times. 

Efficiency in inspections can be also enhanced in normal times. Hybrid inspections can be carried out on a case-by-case basis, and reliance can help reduce redundancies and strengthen relations and trust among NRAs.  

Author

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  Sérgio Cavalheiro Filho Manager, Regulatory Affairs s.cavalheiro_filho@ifpma.org