Reshaped forever

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


Country Reports


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End notes

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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