April 19, 2021
On March 11, 2020, after months of researching, strategizing, and meeting with various leaders and medical experts globally, the World Health Organization (WHO) declared COVID-19 to be a global pandemic. Since then, a lot has happened in the world of COVID-19, especially as it relates to the development of vaccines and treatments for this novel coronavirus. Here are a few of the most significant regulatory-related milestones from the past year.
In March 2020, both FDA and EMA and local national agencies announced that all scheduled face-to-face meetings would be converted to virtual meetings conducted via teleconference. Furthermore, the agencies also announced that all meetings moving forward would be held virtually until otherwise stated. Although extremely necessary given the severity of the global pandemic, this has had a significant impact on the regulators as well as the Sponsors (and naturally, their consultants).
While this has presented many challenges that Sponsors were forced to deal with and overcome quickly, ProPharma Group’s team of regulatory experts were here to help from the very beginning. With a number of our client’s meetings being converted to virtual in the early days of the pandemic, our experts obtained firsthand experience figuring out the best way to prepare for and conduct these meetings extremely early on. Although there is more information available at this point, we remain better equipped to assist clients with their virtual meetings, as we had the advantage of learning from our early experiences and perfecting the approach we take to the preparation and conduct of meetings with both the FDA and EMA during this unprecedented time.
Furthermore, one of the silver linings of all agency meetings being conducted virtually is that we have been able to do away with the onerous desk copies of meeting packages. In addition, the United States government recently joined forces with Zoom, and will now be using it as their meeting platform. Prior to this, FDA always looked to the Sponsor to provide call-in numbers. The Zoom contract may be a signal that FDA is finally going to embrace videoconferencing, as it has been strictly teleconferencing for the most part, with only some divisions being open to conducting videoconferences. Finally, this could also be an indicator that they may be preparing to eliminate or significantly limit face-to-face meetings even post-COVID restrictions.
Over the course of the last six months, there have been a number of COVID-19 vaccines authorized for use across the globe. So far, FDA has granted emergency use authorization (EUA) to three companies that have developed COVID-19 vaccines. These include Pfizer-BioNTech, which was authorized on December 11, 2020; Moderna, which was authorized on December 18, 2020; and Janssen, which was authorized on February 27, 2021. However, it is also important to note, that in a statement released on April 13, 2021, the FDA & CDC recommended “a pause in the use of the Johnson & Johnson (Janssen) COVID-19 vaccine” while they review data from six reported cases of rare but serious type of blood clot in people who received the vaccine in the US. The product is still authorized, but the agencies do not recommend that the product be given to any patients until an updated statement has been issued.
There are three vaccines available for FDA and the EMA authorized the use of numerous COVID-19 vaccines.
In the EU, there are four vaccines that have been granted conditional marketing authorization. These include COVID-19 vaccines developed by Pfizer and BioNTech, which was granted authorization on December 21, 2021; Moderna, which was granted authorization on January 6, 2021; AstraZeneca, which was authorized on January 29, 2021; and Janssen, which was authorized on March 11, 2021. However, earlier this week, the European Commission announced that it will not be renewing its contracts with AstraZeneca or Johnson & Johnson next year amid concerns regarding the safety of the products and significant risks associated with the use of these vaccines.
As health officials around the world were working to learn as much as they could about the virus that was wreaking havoc across the world, in April 2020 the FDA launched a new program called the Coronavirus Treatment Acceleration Program (CTAP). The goal of CTAP is “to move new treatments to patients as soon as possible, while at the same time finding out whether they are helpful or harmful.” Today, the FDA is still using the CTAP program to continue developing products to treat and prevent the spread of COVID-19.
Since it was initiated over a year ago, we have assisted a number of clients with CTAP-related projects and are uniquely qualified to help with any and all of your COVID-related regulatory needs.
Shortly after the start of the pandemic, rapid antigen tests were developed, allowing healthcare professionals to test patients and provide the results in a much shorter timeframe. However, it was not until December 2020 that a formal framework for the use of these tests was laid out by the European Commission (EC). At the same time, the EC also announced that it was purchasing more than 20 million rapid antigen tests for use across all of the EU’s member states.
Also in December 2020, FDA authorized “the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual two years of age or older.”
Another action taken by the agencies that has had a significant impact on Sponsors across the world was the move to conducting on-site inspections virtually. Prior to the COVID-19 pandemic, both the FDA and EMA were hesitant to allow Good Clinical Practice (GCP) audits to be conducted virtually. The reason for this resistance was mainly due to concerns about maintaining confidentiality and credibility for remote inspections. However, when the pandemic took over and nearly the entire world went to doing as much remote work as possible, this changed rapidly.
In March 2020, the FDA issued a guidance document entitled Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency, where it provided “general considerations to assist Sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency.” As there has been additional information learned about the novel coronavirus and the world has learned to function in these unprecedented times, the FDA has updated the guidance document. The most recent version of the guidance document was issued on January 27, 2021 and contains the Agency’s current and updated recommendations.
In May 2020, the EMA provided guidance on the conduct of remote GCP inspections in the face of the pandemic. Shortly after, they issued an additional guidance regarding the conduct and management of clinical trials during this time.
Throughout the past year, our GCP and quality and compliance experts have not slowed down! We have continued conducting remote inspections for clients across the globe. Falling behind on your compliance obligations during this time could be detrimental to the success of your product and company. Our experts can help ensure continued compliance with all regulatory requirements.
Regardless of what your product is or where you are in the product lifecycle, the COVID-19 pandemic has impacted everyone in some way. Whether you are developing products to treat or prevent COVID-19, are in the process of developing a non-COVID related drug or medical device, are seeking assistance to ensure your approved product maintains compliance with all regulatory requirements, or anywhere in between, we are here to help with all of your regulatory-related needs.
With a team of experts located in various geographic regions across the world, we are uniquely qualified to assist with any and all of your EMA and/or FDA-related projects. Whether you need assistance with just the development of your regulatory strategy or you’re looking for a partner to assist through the entire approval process in both the US and the EU, our experts have the knowledge and experience you need to obtain successful interactions with the regulatory agencies. Interested in learning how we can help you? Contact us today to learn more about a global regulatory services.
TAGS: Regulatory Sciences
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