When it comes to the approval of new drugs for consumer use, almost every nation or group of nations worldwide will have a dedicated government agency which is responsible for scrutinizing these new medications. In the United States, this is carried out by the Federal Drug Administration, and in the EU, by the European Medicines Agency. Both carry out intensive testing and scrutinize every proposed product that comes before them. Those aspiring to become regulatory professionals will want to know how current political and market factors are influencing these key agencies.
They Regulate the Two Biggest Drug and Medicine Markets in the World
When it comes to the pharmaceutical industry, few organizations hold as much clout as these two organizations, due to the huge markets they regulate. The US pharmaceutical market’s worth is estimated at $339 billion USD ($431 billion CAD), while the 28 member countries of the EU constitute a market of just over $200 billion USD ($254 billion CAD). Together, these two organizations represent the first and second largest global markets respectively.
This ultimately makes interaction between any sizeable pharmaceutical producer and these two administration bodies almost inevitable. Professionals working in both drug development and regulatory affairs in any nation worldwide, including Canada, will therefore often work towards making sure their products meet the strict requirements of these organizations.
Those With Regulatory Affairs Careers Know There Are Differences in Approval Times
Professionals with a pharmaceutical regulatory affairs diploma know that both the FDA and EMA decide on the admission of new products to their respective markets. However, the history and evolution of each agency has shaped the speed and priorities of the approval process.
The FDA’s role has always been more focused on consumer protection, while EMA was founded to ease cross-border commercial activity while preserving the autonomy of individual EU state regulations. The more centralized nature of the FDA has played a role in creating its more rapid decision-making process, generally delivering a review on new drugs in 306 days, compared to EMA’s 383 days. Currently, the US government is seeking even speedier decisions from the FDA, citing public demand for “orphan” drugs to tackle diseases that don’t yet have established treatments. Meanwhile, EMA is undergoing a historic re-location due to Britain’s impending exit of the European Union, and is currently flagging expected disruption to new drug review processes. This points to a dynamic and changing regulatory environment, as external pressures exert themselves on these key organizations.
Pros With a Pharmaceutical Regulatory Affairs Diploma Know Rigorous Safety Is Still the Priority
Part of what makes pursuing regulatory affairs careers so rewarding is that these paths can truly allow you to make a difference, ensuring that patients around the world can trust that their pharmaceuticals are both safe and effective. The industry’s commitment to safety can be felt at all levels, including the highest branches of the FDA and EMA.
These administrations are made up of teams of professionals who have dedicated their careers to the safety and health of others. These include scientists, chemists, administrators, and legal professionals, who are all tasked with scrutinizing a litany of newly submitted drugs every month. The current FDA Commissioner, Scott Gottlieb, has stressed that while he supports speedier action on decision-making, he fully appreciates that “people’s lives are literally on the line when it comes to the decisions FDA makes, its oversight…”, while EMA’s Deputy Executive Director, Noel Wathion, has said that the agency will strive to ensure the standard of assessment is “not disrupted” by current events. Robust examination and clinical thoroughness will always be applied to every application that comes before these agencies.
Despite a changing environment, all parties point to rigorous safety as being a core aim
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