Preparing for Regulatory Success in 2021
As we all begin to wrap up the year and look ahead to 2021, it is critical to make sure your team is prepared for what is coming in the weeks and months that lay ahead. Preparation and preparedness are key to ensuring regulatory success at any point, but especially as we approach a new year.
It is no secret that 2020 has been a very different and challenging year for all of us. There have been a lot of changes and even more unknowns that have been thrown at us, derailing any plan and preparation that was done at this time last year. With that in mind, it is still critical to have a plan and to look ahead and prepare for the road ahead, but if we have learned anything this year, we just need to make sure these plans are nimble and adaptable.
To assist you in the preparation process, we have compiled a list of five things to keep consider as you prepare for 2021.
- Realize that COVID-19 will continue to have an impact on development
As the year has unfolded, it has become abundantly clear that COVID-19 is not going anywhere anytime soon. With that being said, the pandemic will continue to have a significant impact on product development. Specific impacts that may be experienced due to the global pandemic include:
- Patient recruitment will be challenging as hospitals and clinics respond to COVID-19
- Agency review times may be increased, and formal meetings may be delayed
- Because of this, now more than ever, it is extremely important to be well-rehearsed when conducting virtual meetings with the Food and Drug Administration (FDA) and European Medicines Agency (EMA)/local national agencies.
The best way to overcome these potential challenges and impacts is to simply make sure you are prepared as far in advance as possible. Approach the agencies as early as possible giving yourself extra time to avoid delays in your overall development timeline.
- Thoroughly understand the regulatory requirements of each transaction with regulatory agencies
Each type of submission and meeting with FDA has specific requirements as described in 21 CFR and in associated guidance documents. Make sure that you understand precisely what is expected of you by FDA and/or the EMA/local national agencies.
- Success with the FDA and EMA/local national agencies is driven by scientific arguments and supported by data
FDA reviewers are scientists who make decisions based on your arguments backed up by relevant data. All of your interactions with the regulators should be based upon a transparent scientific approach, so now is the time to be preparing for that and making sure any and all data and information necessary will be available for the meetings, submissions, etc. that you have planned for 2021.
- Make sure that any submission to FDA and/or EMA is flawless
FDA continues to insist on higher levels of quality. Submissions should be proofread for the following:
- Was the foundational work done and was it successful (e.g. was the stability test completed and acceptable)?
- Are the reports from that work complete?
- Are the sections of the submission well-written?
- Does the entire submission tell a cogent story? Are the proper hyperlinks in place to connect sections?
- Is the formatting, spelling, grammar, etc., perfect?
As you think about the submissions that you are planning to file with the regulators next year and the timelines and related activities to be completed, it is critical to factor in ample time for review and proofing of the content before it is sent off to the applicable Agency.
- Prepare thoroughly for formal meetings with the regulators
The differences between great and mediocre meetings are measured in years of time and millions of dollars. When preparing for formal meetings with the regulators, here are a few things to keep in mind:
- Gain an understanding of the key issues of the review group you will be addressing
- Make sure that the Meeting Request Letter and Briefing Document are flawless
- Have the meeting at the right time. If you will have a more productive after receiving critical data, then wait for that data.
- Script the meeting and rehearse. Make sure that you are adept at teleconferences and that your team members can communicate with each other in the background during the meeting
- Prepare to change course upon your receipt of the Agency’s responses prior to the meeting, e.g. you may want to focus the meeting on just a few questions.