FDA and EMA Drug Approval Pipelines
Drug development follows a strict pathway. However, each region applies its own rules.
The FDA oversees the US system. Meanwhile, the EMA regulates medicines across Europe.
Research begins with discovery. Afterwards, scientists test early compounds in the lab.
Only a few candidates show promise. Therefore, they move to preclinical studies.
Animals are used to assess toxicity. Subsequently, researchers analyze dosage and risk.
This stage determines whether human trials may proceed. In many cases, only the safest drugs advance.
Clinical trials unfold in three phases. Initially, Phase 1 checks basic safety.
Phase 2 explores effectiveness. Later, Phase 3 confirms results in larger populations.
Companies prepare extensive applications. For the FDA, this is the New Drug Application.
The EMA reviews a Marketing Authorisation Application. During review, both agencies examine all data.
Some treatments qualify for faster pathways. For instance, the FDA offers Priority Review or Accelerated Approval.
The EMA provides PRIME or Conditional Approval. In turn, these programs speed access for critical conditions.
Independent advisory committees support decision-making. Occasionally, they evaluate complex safety issues.
Their opinions inform regulators. Even so, final approval remains with the agencies.
Post-market surveillance continues after launch. Over time, real-world data reveals long-term risks.
Manufacturers must report problems. If necessary, authorities can modify or revoke approval.
Both agencies share knowledge globally. As a result, standards often align.
This cooperation strengthens patient safety. Ultimately, rigorous oversight ensures that new medicines are both safe and effective.