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The ongoing evolution of life sciences regulation in the wake of COVID-19

Although the seismic tremors of the COVID-19 pandemic have subsided, aftershocks are still being felt. To address the health crisis, industry and regulators collaborated to create a variety of new life sciences regulations, partnerships, and procedures. These efforts were aimed at both expediting the development of COVID-19 vaccines and treatments and ensuring a smooth flow of essential products always needed for the maintenance of healthy populations.

Advancing the assessment


The life sciences industry and its regulators face the challenges of deciding which of these relationships and processes were effective, efficient, and valuable, worthy of adoption into an evolving medical ecosystem as they return to business as usual.

In December 2021, Global Regulatory Intelligence Team (GRIT) at Deloitte published Never the same again: How COVID-19 created seismic change in life sciences regulations,1 a broad look at the global pandemic response. That report offered a deep exploration of how the relationships and collaboration among life sciences companies, national health authorities, and supranational organizations had changed—and how those changes might affect the future of the life sciences industry.

This new report is an update and expansion on that effort. It chronicles developments since the those described in Never the same again, including the end of health emergencies in several jurisdictions and the continuing process of moving new vaccines, drugs, and biological products from emergency use authorization (EUA) to full commercial authorization. And it expands the scope of GRIT’s analysis beyond the original five jurisdictions (China, the European Union, India, Japan, and the United States) by reporting on five additional nations—Argentina, Canada, Colombia, Mexico, and the United Kingdom.

The new shape of the global regulatory landscape

The way countries declared public health emergencies during the COVID-19 pandemic varied greatly across the globe, and this variability persists even as emergency conditions are improving and official declarations are being ended.

Of the 10 jurisdictions reviewed in this report, three countries—Canada, China, and the United Kingdom—did not declare national health emergencies. Instead, they relied on other existing authorities or new legislation to address the pandemic. Three countries declared emergencies but have since revoked them or allowed them to expire—Colombia, Mexico, and Japan. Three countries still had emergencies in place as of the first quarter of 2023 (Argentina, India, and the United States). On May 5, 2023, the World Health Organization (WHO) declared the end of the pandemic. In the United States, the emergency ended on May 11, 2023, after repeated extensions.

In the European Union (EU), member states took different approaches to declaring emergencies. The EU has taken more action than other jurisdictions to address emergency powers. New life sciences regulations that became effective in March 2022 reinforce the role of the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices. These regulations also formally establish the Emergency Task Force (ETF) as an advisory and support body for public health emergencies. The ETF is responsible for accelerating the assessment of scientific evidence on vaccines and medicines that target emergencies.

Read more for steps to consider moving forward

During the first wave of the pandemic in 2020, health authority inspections were reduced in many places. Since then, inspections have increased, but some countries still have fewer inspections than before the pandemic.

To adapt to pandemic conditions, regulators have changed the way they inspect. They now use remote inspections that include document production, remote access to data and electronic systems, video tours of facilities, and video interviews with personnel. Hybrid inspections that mix remote and in-person techniques have also become more common, even in countries that didn’t do virtual inspections before, like Japan. Regulators in Argentina, Canada, China, the United States, and the United Kingdom have issued new guidance on remote or hybrid inspections. These new approaches are especially helpful for smaller markets like Colombia, where faraway, rural facilities make it difficult to inspect.

Read more for steps to consider moving forward

Prior to the pandemic, jurisdictions’ procedures for granting accelerated approval to new vaccines, drugs, or treatments—a status generally known as emergency use authorization (EUA)—varied widely. Those countries that lacked EUA procedures (e.g., Colombia) quickly adopted new regulations specifically for COVID-19 vaccines and treatments. All 10 of the jurisdictions discussed in this report ended up approving vaccines and, in some cases, treatments under EUA-type processes. The average number of EUA-approved vaccines, drugs, and biological products in the 10 jurisdictions was 11, with numbers ranging from five vaccines in Colombia to 18 products (four vaccines, 14 drugs or biologics) in the United States. Smaller countries tended to rely upon the WHO and its Emergency Use Listing Procedure or on approvals in peer or larger jurisdictions in granting EUAs.

In many jurisdictions, relatively few EUA products have transitioned to regular commercial approval: Argentina, China, Colombia, and Mexico—for example—have not approved any EUA products for commercial use, and the United States has transitioned only five EUA products (two vaccines and three drugs or biologics) to commercial approval.
Conversely, revocations of drug and vaccine EUAs have been rare, as have been recalls or compliance problems for EUA vaccines or treatments. Those low rates of revocation or recall are a testament to the risk–benefit analysis that, in most cases, preceded the invocation of EUA procedures.

Many countries have intensified their surveillance for adverse reactions. Colombia and India, for example, launched new online platforms for adverse reaction reporting.

Read more for steps to consider moving forward

The COVID-19 pandemic acted as a catalyst on efforts in many jurisdictions to accelerate drug approvals, modernize clinical trials, and advance the use of telemedicine.

Canada and other jurisdictions are applying lessons of the pandemic to efforts to make drug licensing more agile. The European Commission is preparing to enact legislative revisions to improve timelines and speed patient access to new medications by removing unnecessary steps and reinforcing expertise-driven assessments. The UK government has announced a Life Sciences Vision Program intended to apply lessons learned from the COVID-19 response to other daunting health problems, including dementia, cancer, and aging. In India, the government has issued guidelines directing states and union territories to build buffer stocks of drugs used for COVID-19.

In each of the 10 jurisdictions discussed in this report, efforts to modernize clinical trials were launched or accelerated in response to pandemic conditions. Techniques included use of digital tools for finding trial subjects, obtaining subject consent, and monitoring trials; home delivery and administration of trial drugs; and streamlining of trial design and approval. In Europe, EMA launched an online platform to facilitate multinational clinical trials, for which sponsors can seek authorization to conduct trials in up to 30 countries with one application.2 The US Food and Drug Administration (FDA) has issued draft guidance on use of digital health technologies for gathering data remotely in clinical investigations.3

Telemedicine also gained greater regulatory flexibility, particularly in countries (e.g., Japan) where adoption had been low. In India, the government released a national telemedicine platform, called eSanjeevani, for patient-to-provider and provider-to-provider consultations.4

Read more for steps to consider moving forward

The urgent need to respond to the COVID-19 pandemic broke down barriers and spurred a wave of collaborative efforts among players in the life sciences ecosystem—health authorities, global bodies, life sciences companies, and others in the health care system. These collaborations were a major focus of Deloitte’s 2021 report, Never the same again.

As pandemic conditions eased, many of those collaborative relationships appear to have persisted and deepened, including:

  • Transnational collaborations among regulators and health authorities
  • Collaborations between regulators and industry
  • International collaborations involving health authorities and life sciences companies
  • Industry collaborations

Read more for further details regarding collaborations and steps to consider moving forward

Country reports

Canada did not declare a national state of emergency in response to the COVID-19 pandemic.5 Provinces declared health emergencies, and some are still ongoing.6 The government addressed urgent needs for health products through measures implemented in a series of one-year “interim orders” (IOs). Continuation of measures was ensured through subsequent IOs or updates to the regulations. These measures authorize a wide range of actions, including prohibiting exportation of certain drugs if those products are in short supply in Canada, facilitating COVID-19-related clinical trials, and granting flexibility to makers of certain products, including drug-based hand sanitizers.7

Download the full report for more details regarding:

  • Modernizing inspections
  • Emergency use authorization developments
  • Changes in drug regulation
  • Collaborations

The United States continued to operate under a COVID-19 public health emergency until recently.8 In January 2023, the White House announced plans to lift the state of emergency effective May 11.9 In August 2022, the US Centers for Disease Control and Prevention streamlined its COVID-19 guidance to help people cope with continuing outbreaks.10

US health authorities continue to stress the value of vaccination against COVID-19, with recent efforts focusing on bivalent boosters to address both the original and omicron strains of SARS-CoV-2.11 In September 2022, the US FDA began authorizing bivalent boosters, culminating in approval in December 2022 for children as young as six months old.12

Download the full report for more details regarding:

  • Modernizing inspections
  • Emergency use authorization developments
  • Changes in drug regulation
  • Collaborations

Argentina declared a public health emergency after early cases of COVID-19 were detected in March 2020; the emergency was extended twice and remains in place until December 2023.13

Download the full report for more details regarding:

  • Modernizing inspections
  • Emergency use authorization developments
  • Changes in drug regulation
  • Collaborations

Colombia declared a health emergency under constitutional powers in March 2020.14 The emergency was lifted in June 2022.15 More than 800 health-related administrative orders were issued under the emergency.16

Download the full report for more details regarding:

  • Modernizing inspections
  • Emergency use authorization developments
  • Changes in drug regulation
  • Collaborations

The General Health Council of Mexico declared a sanitary emergency and lockdown in March 2020.17 The lockdown was lifted in April 2020, but other measures (e.g., school suspensions, social distancing, and use of face masks18 ) persisted into 2022 in various states. States have since lifted the emergency.19

Download the full report for more details regarding:

  • Modernizing inspections
  • Emergency use authorization developments
  • Changes in drug regulation
  • Collaborations

The European Commission has stated that the EU is in a “post-emergency” phase.20 The EU’s formal emergency status follows the World Health Organization (WHO), which declared that COVID-19 was no longer a public health emergency on May 5, 2023.21 Each member state has pursued its own emergency status.

New regulations in the EU have sought to codify lessons learned from the COVID-19 response. Regulation (EU) 2022/123, effective in March 2022, provides a reinforced role for the EMA in crisis preparedness and management for medicinal products and medical devices.22 The regulation also formally established the ETF as an advisory and support body for public health emergencies. The ETF is tasked with accelerated assessment of scientific evidence on vaccines and medicines targeting an emergency.23

Download the full report for more details regarding:

  • Modernizing inspections
  • Emergency use authorization developments
  • Changes in drug regulation
  • Collaborations

The government of the United Kingdom did not declare a national health emergency in response to COVID-19.24 Instead, Parliament enacted the Coronavirus Act 2020, with a wide range of temporary provisions, most of which expired in March 2022.25

Download the full report for more details regarding:

  • Modernizing inspections
  • Emergency use authorization developments
  • Changes in drug regulation
  • Collaborations

While China never declared a national emergency in response to COVID-19, several regions of China have maintained the highest level of response (level 1) to the pandemic. Prevention and control measures have evolved significantly, however, since spring 2021. Quarantine periods and testing requirements were reduced in stages.26 Most notably, China dropped its “Zero COVID” approach in December 2022, as economic concerns and widespread public protests of lockdowns outweighed fears of a renewed outbreak.27

Download the full report for more details regarding:

  • Modernizing inspections
  • Emergency use authorization developments
  • Changes in drug regulation
  • Collaborations

In India, the COVID-19 emergency declared under the Disaster Management Act of 2005 ended in November 2021.28 The government of India established working groups in March 2020 to address 11 different aspects of COVID-19 management, ranging from medical emergency planning to ensuring availability of essential medical equipment to coordination with the private sector.29 The government also implemented measures to contain the spread of COVID-19, which it adjusted as the pandemic evolved.30 The Ministry of Health and Family Welfare issued guidelines for management of COVID-19 in children in June 202131 and for management of post-COVID sequelae in October 2021.32

Inbound travelers from designated high-risk countries remained subject to testing requirements as of January 2023.33

Download the full report for more details regarding:

  • Modernizing inspections
  • Emergency use authorization developments
  • Changes in drug regulation
  • Collaborations

Japan declared four states of emergency between April 2020 and September 2021, each one lasting one to four months.34 The process for emergency declarations has not changed.

Download the full report for more details regarding:

  • Modernizing inspections
  • Emergency use authorization developments
  • Changes in drug regulation
  • Collaborations

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1Terence Yifan Cai et al., Never the same again: How COVID-19 created seismic change in life sciences regulation, Deloitte, December 23, 2021.
2European Medicines Agency (EMA), “Clinical trials information system,” accessed February 7, 2023.
3US Food and Drug Administration (FDA), “Digital health technologies for remote data acquisition in clinical investigations,” December 2021.
4Government of India Ministry of Health and Family Welfare (MoHFW), “Telemedicine regulations,” press release, July 30, 2021.
5Department of Justice Canada, “Canada’s Emergencies Act,” updated February 25, 2022.
6CP24, “A timeline of events in Canada’s fight against COVID-19,” December 15, 2020; Mia Rabson, “WHO decision on COVID-19 emergency won’t affect Canada’s response: Tam,” CTV News, January 27, 2023.
7Health Canada, “Regulations amending certain regulations concerning drugs and medical devices (shortages): Notice,” February 26, 2022.
8Xavier Becerra, “Renewal of determination that a public health emergency exists,” US Department of Health and Human Services (HHS) Administration for Strategic Preparedness & Response (ASPR), January 11, 2023.
9Juliette Cubanski et al., “What happens when COVID-19 emergency declarations end? Implications for coverage, costs, and access,” Kaiser Family Foundation, January 31, 2023.
10Spencer Kimball, “CDC eases COVID guidance as U.S. has more tools to fight the virus and keep people out of the hospital,” CNBC, August 11, 2022; US Centers for Disease Control and Prevention (CDC), “CDC streamlines COVID-19 guidance to help the public better protect themselves and understand their risk,” press release, August 11, 2022.
11Alice Park, “FDA experts vote to make all COVID-19 vaccines and boosters bivalent,” Time, January 26, 2023.
12US FDA, “Coronavirus (COVID-19) update: FDA authorizes updated (bivalent) COVID-19 vaccines for children down to 6 months of age,” press release, December 8, 2022; CDC, “COVID data tracker: COVID-19 vaccinations in the United States,” accessed February 6, 2023.
13Información Legislativa y Documental (InfoLEG), “Social solidarity and productive reactivation law in the framework of public emergency,” accessed February 7, 2023; InfoLEG, “Decree DNU 260/2020 National Executive Branch,” March 12, 2020; Official Bulletin of the Republic of Argentina, “Health emergency: Decree 867/2021,” December 23, 2021; Argentina National Executive Branch, “Decree 863/2022, Public emergency in sanitary matter: Extension,” December 29, 2022.
14Government of Colombia, Single Regulatory Information System (SÚN), “Decree 457 of 2020,” March 22, 2020.
15Ministry of Health and Social Protection (MSPS), “Resolution No. 385,” March 12, 2020 (in Spanish).
16MSPS, “Resolution No. 666 of 2022,” April 28, 2022 (in Spanish); MSPS, “Measures against the COVID-19 pandemic,” accessed February 10, 2023.
17General Health Council of Mexico (CSG), “AGREEMENT by which the General Health Council recognizes the epidemic of disease caused by the SARS-CoV2 virus (COVID-19) in Mexico, as a serious disease requiring priority attention, as well as establishing the activities for preparation and response to said epidemic,” March 23, 2020 (in Spanish).
18Government of Mexico City, “Health emergency,” accessed February 9, 2023 (in Spanish).
19CSG, “AGREEMENT declaring a health emergency due to force majeure, the epidemic of disease generated by the SARS-CoV2 virus (COVID-19),” March 30, 2020 (in Spanish).
20Francesco Guarascio, “Exclusive: EU to move away from emergency phase of COVID pandemic – document,” Reuters, April 26, 2022.
21WHO, Statement on the fifteenth meeting of the International Health Regulations (2005) Emergency Committee regarding the coronavirus disease (COVID-19) pandemic,” May 5, 2023.
22EUR-Lex, “Regulation (EU) 2022/123,” January 25, 2002.
23EMA, “Emergency Task Force (ETF).”
24University of Cambridge, Bennett Institute for Public Policy, “The history of emergency legislation and the COVID-19 crisis,” April 28, 2020.
25UK Parliament, House of Commons Library, “Expiry of the Coronavirus Act’s temporary provisions,” March 2, 2022; Legislation.gov.uk, “The Coronavirus Act 2020 (Delay in expiry: Inquests, courts and tribunals, and statutory sick pay) (England and Wales and Northern Ireland) regulations 2022,” March 24, 2022.
26National Health Commission, “Notice on printing and distributing the diagnosis and treatment plan for novel coronavirus pneumonia (ninth trial version),” March 14, 2022 (in Chinese).
27Selina Cheng, “China scraps most COVID testing, quarantine requirements in policy pivot,” Wall Street Journal, December 7, 2022.
28Government of India National Disaster Management Authority, “Order for extending the lockdown period,” April 14, 2020.
29MoHFW, “Ministry of Health & Family Welfare 2020 achievements,” December 30, 2020.
30MoHFW, “Effective response in the face of a pandemic: Measures adopted by the government of India to combat COVID-19,” December 24, 2021; MoHFW, “Ministry.”
31MoHFW, “Guidelines for management of COVID-19 in children (below 18 years),” June 18, 2021.
32MoHFW, National comprehensive guidelines for management of post-COVID sequelae, accessed February 14, 2023.
33MoFHW, “Guidelines for international arrivals,” December 29, 2022.
34Government of Japan, “Report on the status of implementation of the state of emergency declaration,” June 2020 (in Japanese); “Report on the status of implementation of the state of emergency declaration,” October 2021 (in Japanese).

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