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Regulatory Agilities During the COVID-19 Pandemic:
Observations from a Multinational Pharmaceutical Company
Julie O’Brien
Pfizer
Rebecca Lumsden
Pfizer
M

uch has been written about the experience and learnings from a regulatory point of view during the COVID-19 pandemic. Large multinational innovative pharmaceutical companies developing COVID-19 vaccines and therapeutics, and supplying critical medicines, are experiencing this reality daily. The following practical actions were deployed by regulatory authorities and collectively experienced by industry to ensure the continued smooth functioning of regulatory systems during the pandemic. We propose that there is an imperative to continue to build on many of these actions to accelerate regulatory strengthening even further in international markets and to make some of these practices permanent.

During 2020, we internally documented the practical application of newly created regulatory agilities in relation to our specific products. Countries within scope included those in Africa, Asia (excluding China and Japan), Middle East, and Latin America. Clinical trial-related practices were out of scope. Four primary categories of regulatory agilities were identified as described in the attached table. Whilst not comprehensive, collected examples spanned 30 countries and more than 30 products, and more than 65 individual examples were recorded, demonstrating the widespread use of regulatory agilities deployed during the pandemic. These agilities were applied to ensure that patient access to non-COVID-19 medicines was maintained despite the challenges posed by the pandemic. In many countries, the regulatory agilities observed were not limited solely to COVID-19-related products. The product-specific examples collected spanned the breadth of our portfolio and included products across different therapeutic areas.

While many agilities served the purpose of ensuring that product access was maintained during the pandemic, an impact on the speed of submission, review, and approval was noted in a number of countries. Electronic provision of ancillary documents provided time savings of up to six months, dependent on national processes; it must be acknowledged, however, that the examples in this study were collected in real time and can only serve as an indication of potential time savings.

Given the limited scope of our observations, it is likely that many more regulatory authorities are also deploying similar types of regulatory agilities in practice. Although not product specific, Rei Bolislis et al. have reported extensive deployment of regulatory agilities by regulatory authorities during the COVID-19 pandemic.

Categories
Examples

Examples Collated from These Regions and Countries1

Certificate of Pharmaceutical Product (CPP)
  • For new submission, extension, variation before end of 2021: Active Pharmaceutical Ingredient/Drug Product (API/DP) specification: API manufacturers not required on CPP
  • Acceptance of electronic CPP (eCPP)
  • Acceptance of unlegalized CPP
  • Acceptance of 1 CPP (from European Medicines Agency) instead of 2 CPPs (as usually required) 2
  • Acceptance of eSigned/eLegalized CPP
  • Approval of new indication without CPP
  • CPP verification in parallel to review and after approval
Africa: Ethiopia, Nigeria, Tanzania, Uganda
Asia: India, Macau, Pakistan, Taiwan, Thailand, Vietnam
Middle East: Bahrain, Oman, Qatar, United Arab Emirates
Latin America: Costa Rica, Peru, Uruguay
Waivers, including manufacturing (variety of areas outside of CPPs)
  • Local sterility testing waiver
  • Acceptance of nonlocal product/language 3
  • Provision of ancillary documents as a post-approval commitment
  • Copies of documents accepted for manufacturing site licence renewal
  • Site legal entity name change application made without legalized GMP Certificate
Asia: India, Indonesia, Malaysia, Pakistan, Singapore, Taiwan, Thailand, Vietnam
Middle East: Bahrain, Oman, Qatar, United Arab Emirates
Latin America: Brazil, Colombia, Costa Rica, Ecuador, Uruguay
Digital
  • Multiple examples of online submission of Common Technical Dossiers (CTD)
  • Query response permitted by email
  • Submission of new registration via digital platform
  • Post-approval commitment submission via digital platform
  • First electronic CTD (eCTD) submission in a particular country
Africa: Nigeria, South Africa
Middle East: Bahrain, Qatar
Latin America: Ecuador, El Salvador, Honduras, Panama
Good Manufacturing Practices (GMP)
  • Acceptance of electronic GMP (eGMP) Certificate
  • Extension of validity of GMP Certificate
Asia: Thailand, Vietnam
Middle East: United Arab Emirates
Latin America: Argentina, Colombia, Ecuador, Peru
1 For each category of agilities, all listed examples were not necessarily implemented by every country listed.

2 Examples in italics demonstrate elements of reliance on other regulator’s activities.

3 Examples include importation into a market of a product that was approved in and manufactured for another market.

Certificate of Pharmaceutical Product (CPP)
Examples
  • For new submission, extension, variation before end of 2021: Active Pharmaceutical Ingredient/Drug Product (API/DP) specification: API manufacturers not required on CPP
  • Acceptance of electronic CPP (eCPP)
  • Acceptance of unlegalized CPP
  • Acceptance of 1 CPP (from European Medicines Agency) instead of 2 CPPs (as usually required) 2
  • Acceptance of eSigned/eLegalized CPP
  • Approval of new indication without CPP
  • CPP verification in parallel to review and after approval
Examples Collated from These Regions and Countries1

Africa: Ethiopia, Nigeria, Tanzania, Uganda
Asia: India, Macau, Pakistan, Taiwan, Thailand, Vietnam
Middle East: Bahrain, Oman, Qatar, United Arab Emirates
Latin America: Costa Rica, Peru, Uruguay

Waivers, including manufacturing (variety of areas outside of CPPs)
Examples
  • Local sterility testing waiver
  • Acceptance of nonlocal product/language 3
  • Provision of ancillary documents as a post-approval commitment
  • Copies of documents accepted for manufacturing site licence renewal
  • Site legal entity name change application made without legalized GMP Certificate
Examples Collated from These Regions and Countries1

Asia: India, Indonesia, Malaysia, Pakistan, Singapore, Taiwan, Thailand, Vietnam
Middle East: Bahrain, Oman, Qatar, United Arab Emirates
Latin America: Brazil, Colombia, Costa Rica, Ecuador, Uruguay

Digital
Examples
  • Multiple examples of online submission of Common Technical Dossiers (CTD)
  • Query response permitted by email
  • Submission of new registration via digital platform
  • Post-approval commitment submission via digital platform
  • First electronic CTD (eCTD) submission in a particular country
Examples Collated from These Regions and Countries1
Africa: Nigeria, South Africa
Middle East: Bahrain, Qatar
Latin America: Ecuador, El Salvador, Honduras, Panama
Good Manufacturing Practices (GMP)
Examples
  • Acceptance of electronic GMP (eGMP) Certificate
  • Extension of validity of GMP Certificate
Examples Collated from These Regions and Countries1

Asia: Thailand, Vietnam
Middle East: United Arab Emirates
Latin America: Argentina, Colombia, Ecuador, Peru

1 For each category of agilities, all listed examples were not necessarily implemented by every country listed.

2 Examples in italics demonstrate elements of reliance on other regulator’s activities.

3 Examples include importation into a market of a product that was approved in and manufactured for another market.

Conclusions

Even while acknowledging that all stakeholders were working on an emergency basis during the pandemic, it is evident that these agilities have resulted in new efficiencies in regulatory systems. These efficiencies extend beyond COVID-19 vaccines and therapeutics. Key areas such as digitization of regulatory work practices, acceptance of electronic ancillary documents, regulatory authority acceptance of electronic copies in lieu of paper submissions, and waiving legal certification, as well as the greater use of reliance on other regulators’ activities, have served to strengthen and protect the functioning of regulatory systems globally. We propose that all stakeholders should continue to build on these areas to accelerate regulatory strengthening in international markets, thus supporting approvals of new medicines as well as ensuring continued supply of already approved medicines.

In contrast, we have observed that multiple administrative post-approval commitments have accompanied these agilities; e.g., provision of hard copy and legalized documents post-pandemic, negating these efficiencies to some extent. We propose that these do not serve a scientific, regulatory, patient safety, or efficacy purpose, and we urge regulators to consider waiving the requirement to provide these hard-copy documents as future post-pandemic commitments.

The authors wish to acknowledge and thank all colleagues who contributed to this work and reviewed this report.

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