The COVID-19 pandemic has had a drastic impact on all the activities related to the development, assessment and approval of medicines and vaccines, unlocking opportunities to work in more agile and collaborative manners.

To accelerate R&D and ensure continuity of regulatory activities, national regulatory authorities (NRAs) and the biopharmaceutical industry successfully implemented regulatory agilities. These agilities, consisting of quicker, streamlined and more efficient ways of working, have been key to allow the rapid development, assessment and approval of safe, effective and quality medicinal products.

Between 2021 and 2022, IFPMA assessed regulatory agilities used during the pandemic and focussed on identifying learnings to improve both pandemic preparedness and standard regulatory processes. IFPMA 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.

Agilities in decision-making processes

Risk-based approaches to the evaluation and approval of medicinal products were applied by NRAs to enable rapid access to vaccines and medicines.

For example, NRAs implemented rolling reviews, which allow to assess data as it becomes available and request information or clarifications quicker than in a traditional review pathway. Moreover, exceptional authorizations such as EMA’s Conditional Marketing Authorization or US FDA’s Emergency Use Authorization also supported timely access to vaccines.

Communication and collaboration

Increased communication and coordination among multiple stakeholders, such as decision makers, multilateral organizations, the biopharmaceutical industry and NRAs, were crucial in the common fight against COVID-19. More frequent and spontaneous interactions among NRAs and the industry were observed during the first steps of the regulatory review process, facilitating alignment and data requirements for submissions.

To maximize efficiency in product evaluations, some NRAs conducted collaborative assessments. For example, the EMA’s OPEN Pilot allowed WHO and NRAs from outside the EU to take part in EMA’s scientific evaluations, sharing scientific expertise and promoting transparency.

It is reasonable to think that the collaborative consultations between industry and regulators, as well as among regulators, allowed safe and effective vaccines to be available as of the first year of the pandemic, saving an estimated 20 million lives.

Labelling and packaging

Regulatory agilities related to labelling and packaging of medicinal products, such as waivers for some labelling requirements, were granted to speed up their availability to patients. In the EU for example, a single language format (in English) for COVID-19 products was approved.

Electronic labelling (e-labelling), such as the use of QR code instead of a physical label to access medicinal product information) was also increasingly adopted globally, eliminating risks of supply delays due to printing of ‘traditional’ labels.

How could regulatory systems be improved in the future?

Many regulatory agilities have been introduced as a temporary solution to the pandemic’s challenges. However, learnings from this experience can help us in the long-term to not only better combat a future pandemic, but also to enhance day-to-day regulatory activities.

In case of new pandemic, NRAs should agree on a global framework of streamlined regulatory requirements to guarantee better convergence and predictability. Divergent regulatory requirements among countries (for instance on data and approval processes) represented a challenge for the industry in their attempt to quickly provide access to medicines during the COVID-19 pandemic. When facing a new pandemic, risk-based approaches should be encouraged and, when appropriate, waivers for regulatory requirements granted, to speed up regulatory decisions whilst maintaining acceptable levels of quality and safety.

In times of crisis, unity is strength. Therefore, collaboration among NRAs should be maximized. This can be done, for instance, by engaging in collaborative assessments or relying on other NRAs’ regulatory decisions to increase efficiency. Increased alignment among NRAs and the industry will also be beneficial to ensure clarity on requirements and speed up processes.

Ample scope remains to also improve standard regulatory processes regionally and globally. Risk-based approaches in normal times can help address urgent unmet needs. Collaborative approaches, joint initiatives and reliance can improve efficiency and build trust among NRAs.

New practices enabled by digitalization should also be embraced. For example, e-labeling facilitates sharing of updated information in a timely and efficient manner, minimizing risks to patient safety linked to time-lag from when the information is updated to when it is made available. Additionally, e-labelling also promotes environmental sustainability, eliminating need for printing.

To sustain innovation and increase efficiencies in the development, evaluation, production and distribution of medicines, it is key to keep strengthening and innovating regulatory systems. The use of regulatory agilities, during both normative processes and health emergencies, can help reach this objective and facilitate timely patient access to safe, efficacious and high-quality medicines.

Author

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  Janis Bernat Director, Scientific and Regulatory Affairs j.bernat@ifpma.org