I believe that the FDA moves at a faster pace due to the fact that you have so many options to speed up the process. If there are already other clinical trials for a material that is being used in the device and you can prove that it will be used in the same manner, most of the time the process is smoother. Even though the approval is only a few months faster than the EMA, the years that it takes to create the device and get that data to prove that your device would be safe and effective within patients is what takes the most time. The EMA also has applications to do an accelerated approval. Since it is only a few months apart, I believe that it could be possible the EMA might be allowing more time for the applicants to get more data to answer their questions and provide ample supporting data to show that their drug would be safe for the public as well as show its efficacy. With the FDA, there are several options that you can use to speed up your approval process such as accelerated approval,  providing a breakthrough therapy, requesting a priority review, requesting a fast track or becoming part of the orphan drug program. Even though the approval is slightly faster, all these drugs still have additional work after such as patent disputes, issues with manufacturing, and even getting a controlled substance designation. 

I think to answer the question, it is most likely neither. It cannot be that the EMA is working more effectively or in detail, due to what our professor said at the end of the lecture this week, that Europe's EMA is lacking in a stable regulatory office, hence why jobs in Regulatory is so high in demand in Europe currently. However, I cannot say if that entails that the FDA is working better, because the only strategy the FDA has to approve of drugs is to review all the materials and ensure that the drug performs as intended. EMA on that note, has 4 different methods on how to properly approve of new drugs; national, mutual recognition, centralized and decentralized processes of authorization. Among these, studies have shown that the centralized process of authorization is most similar to that of the FDA, however only 10% of the drugs approved go through this process. As a result, because the process most similar to the FDA is used the least, the EMA does not approve of as many drugs as the FDA, however, I cannot for certain say that is because they are less qualified, when not speaking of their regulatory department. This is because the differences in generic drug approvals are simply a little too large. For example, in the year 2020 the EMA approved of 15 generic drugs when compared to the FDA's 754 generic drugs. These numbers cannot attain to whose method is superior or not, considering the FDA has come under fire many times for unauthorized drugs or drugs that are not fully functional. 

I believe that the process of both the FDA and the EMA is justified by both companies. Within the United States, a company would submit their drug approval application to the ANDA which is then reviewed so that no possible harm can come to the consumer after ingesting the product. On the other hand, the EMA has four possible routes for approval for applicants, which can derail the time for marketization but can reassure that the product is safe for the consumer. While they have been successes and failures that have occurred in the FDA process, the EMA process doesn't benefit consumers who are in dire need of the medication that needs approval, especially if it's a drug already approved by the FDA. All in all, I believe that combining both the FDA and EMA processes could benefit consumers everywhere as it can lead to a better streamlined and thorough process of approving drugs safely.

A good way to look at this question would first be to examine the two places these companies govern. The FDA regulates everything inside the United States and the EMA regulates everything inside Europe. The US and Europe have very different atmospheres when it comes to producing and developing new products/goods that would fall under the regulations of these administrations and it would be unfair to purely judge the work quality by the speed at which things get approved. While I am not too familiar with how things go in Europe, I do know that capitalism in the US encourages new and existing companies to create new products and bring them to the market. The sheer amount of patents and document regulations that the FDA deals with on a regular basis means that they do not have a choice other than working quickly and efficiently through everything. It does not make them the superior agency, but rather is just a reflection of the environment that they regulate over. There might be statistical evidence that one company might be working more in detail over the other but as long as the tasks are getting completed and they are making sure these companies are following regulations, a comparison like this is a moot point. Both organizations play a vital role in this age of new developments and it is important that the process of going through them before anything hits the market is very valuable and must be maintained.

To bounce off of the ideas from the poster above me, the fact that the FDA is only managing the drug/device development process within a single country while EMA must govern the entire continent of Europe I think we can see where one agency may be able to speed up the process than the other. I think also with the difference in the approval process between the two agencies there comes another reason why the FDA may pull ahead. The FDA has the drug/device development applications and process reviewed by the staff under the FDA. The EMA product review process is done by multiple agencies belonging to the states in the European Union. When having many parties involved in the review process, it can be tricky to push the approval process along.

Posted by: @mert

While FDA provides drug regulation in the United States, EMA provides it in Europe, and EMA is the short form European Medicines Agency. According to a study done in 2017 (DOI: 10.1056/NEJMc1700103
), the FDA approves more drugs and approves them more quickly than the EMA.

Do you think this rapid and more drug approval situation shows that the FDA is working better? Or is the EMA working in more detail and extending the approval period?

The FDA's rapid work rate can be due to more employees working for the FDA. A quick google search shows that there are about 10,000 employees for the FDA and only 900 employees for the EMA. The FDA has over ten times the amount of employees as the EMA showing that the FDA can work ten times faster than the EMA. So this does not necasirilly mean the FDA is working better than the EMA, but it means that there are more people to get the jobs done faster. Another reason it is taking longer for the EMA to get its drugs approved is because of the longer review process done by the EMA. The EMA review process is checked by multiple agencies, as stated above. So it can be challenging to pass products if everyone is not in agreeance.

I agree with what @AJY6 has to about the fact that the FDA is able to accomplish more at a faster rate than the EMA simply because they have over 10,000 employees working for them while the EMA has 897 employees. Additionally, the FDA covers a wider variety of fields such as food, drugs, devices, biologics, etc. while the EMA's primary focus stays within drugs and biologics. The output from the FDA is at a much higher pace because of the demand as well as the ability to process these requests with the size it has. Furthermore, when looking at the various processes that may be taken whether you are creating a drug, device, or biologic, each pathway has specific steps that can help people bypass certain approvals when they are unnecessary for their proposed idea. For example, if the proposed idea is a device that is safe and predicted to be effective while being a last resort type of treatment, one can file for a Humanitarian Device Exemption (HDE) and be able to have less than 4000 patients per year and be able to test their device. With a system like this in play, experimental devices can be tested and further innovation is promoted in fields where there may not be many effective treatments.

I agree with points made above by previous users including the difference in review process. I particularly want to expand on the point regarding the difference in protocol for review of data. Each agency has different standards for determining data strength. Conclusions about data strength in supporting drug efficacy are a major factor in the review process. The differing standards for acceptable ranges of drug performance and preparation can lead to differing conclusions regarding the final decision. This factor can better explain the difference in approval rate between the FDA and EMA. In addition, the approval rate that was recorded may be affected by the timing of submission to each agency, if they are not simultaneous. If the first submission is sent to FDA, it is possible the application sent to the EMA has more up to date data. Separate data sets can greatly impact how data is interpreted.

The regulation of medical drugs and devices involves competing goals of assuring safety and efficacy while providing rapid movement of innovative therapies through the investigative and regulatory processes as quickly as possible.  The United States and the European Union approach these challenges in different ways. Whereas the United States has always relied on a strictly centralized process through 1 agency, the Food and Drug Administration (FDA), the European Commission synchronized the regulations of 28 different countries as they combined to create the European Union.  The FDA historically developed as a consumer protection agency, whereas the regulations from the European Commission arose out of a need to harmonize inter-state commercial interests while preserving national “autonomy.”  Thus, whereas the FDA has the advantages of centralization and common rules, the European Union regulates medical drug and device approvals through a network of centralized and decentralized agencies throughout its member states.  A new study published by the New England Journal of Medicine compared the review times by the FDA and the European Medicines Agency (EMA) for new drugs approved between 2011 and 2015.  The authors gathered a list of drug approvals for both agencies and grouped the drugs by therapeutic area and orphan status.  Then, the investigators examined key regulatory dates and compared median review times.  Between 2011 and 2015, the authors discovered that the FDA approved 170 new drugs, while the EMA only approved 144 new drugs. The therapeutic areas of approved drugs were observed to be similar between the agencies, according to the study.  The authors also discovered that the FDA designated 43.5% of new approvals as orphan drugs, while the EMA only designated 25%.  At the FDA, the median review time was 306 days, compared with 383 days at the EMA, confirming that the FDA reviews drugs faster, according to the study.  The authors found that the FDA had quicker reviews for drugs that treat cancer, hematologic disorders, and orphan diseases.  Differences in review time were also found among drugs that were approved by both agencies.  For the 142 drugs approved by the FDA and EMA, the median total review time was 303 days for the FDA and 369 days for the EMA, according to the study.  The authors discovered that for the approved drugs, the FDA’s regulatory reviews were typically 60 days shorter than the other agency.  These findings were similar to those discovered by the authors when examining the review process between 2001 and 2010, according to the study.  While there has been an increased focus on speeding up the drug approval process, these study results indicate that the FDA reviews and approves drugs faster than the EMA, which may not require regulatory reform.  “Our analysis provides reassurance that the FDA continues to complete regulatory reviews more quickly than the EMA and has the potential to inform discussions regarding the reauthorization of the PDUFA,” the authors concluded.  Globally, the largest share of medical drugs and devices are investigated and approved in the United States and in the EU.   Although the regulatory processes in the United States and Europe share common goals and have many similarities, the different histories of drug and device regulation in both regions contribute to significant regulatory dissimilarities.  Whereas the FDA was founded as a centralized consumer protection agency, the current European systems were driven out of a need to standardize commercial rules across the European member states.  As a result, the FDA is sometimes seen as overplaying safety concerns at the cost of commercial enterprise, whereas the European systems are sometimes characterized as being primarily concerned with preserving commercial interests to the detriment of patient safety.  Despite assertions that drugs are approved more slowly in the United States, analysis indicates that they actually reach the public more quickly in the United States than Europe.  Whether there is a true “device lag” between Europe and the United States is less clear.  Nevertheless, device safety concerns and device failures on both sides of the “pond” have lead both the United States and EU to seek greater mutual cooperation, and to explore tightening regulation regarding device approvals.  Legislative efforts in both the United States and EU are currently underway to promote transparency and mutual standardization of drug and device approval processes.

In this scenario I do not believe that one is necessarily working better or more in detail than the other, it is more-so a matter of a difference in priorities and regulatory philosophies between the two agencies. When looking at the FDA in the United States, they tend to place an emphasis on speed and innovation. In order to do so, the FDA has implemented several programs aimed at expediting drug approval, particularly for treatments that address unmet medical needs or life-threatening conditions. Programs such as Accelerated Approval, Breakthrough Therapy Designation, and the Priority Review system allow the FDA to approve drugs faster based on surrogate endpoints. This focus on speed can get promising treatments to patients faster but also raises concerns about longer-term safety data and the potential for unexpected side effects.

As for the EMA that is provided in Europe, they tend to place an emphasis on thoroughness and caution. The EMA typically takes a more conservative approach, conducting thorough evaluations of safety, efficacy, and quality before granting approval. While they still have similar expedited pathways as the FDA, they prefer to wait for more clinical data results before placing the drug on the market. This cautious approach helps mitigate the risk of safety issues down the line, but it also slows patient access to potentially beneficial treatments. Whether this signals that one is “working better” than the other depends on how one evaluates the balance between speed and safety, patient access, and rigorous review standards.