The FDA, the Federal Drug Administration, is the regulating body that is to protect public health by ensuring drugs, food, cosmetics, and medical devices are safe and effective. They are to protect the United States citizens. How does it work in Europe?
European Medicines Agency (EMA)
The European Medicines Agency (EMA) is the decentralized body that is responsible for ensuring medicines for human and veterinary for those in the European Union. It is also commonly called the European Medicines Evaluation Agency (EMEA).
From a high level, the approval process for a company to produce and sell a drug in Europe is very similar to the FDA. The EMA completes a scientific evaluation of the drugs safety and efficacy which includes audits of the company’s procedures, manufacturing spaces, and drug trial data. The approval is called “marketing authorization”. Once a company receives it, the drug can be marketed and sold to the members of the European Union.
To get approval, the EMA is analyzing how the company is following the guidelines and rules. The EMA’s Committee for Medicinal Products for Human Use (CHMP) publishes their guidelines as EudraLex – Volume 4 of “The Rules Governing Medicinal Products in the European Union” and is broken up into Parts and several Annexes.
Part 1 and the included chapters cover the basic requirements such as quality systems, documentation, quality control, self inspection, complaints and product recall. Part 2 covers the the requirements for active substances as starting materials. Part 3 contains several GMP documents and templates to be used.
Now also included in Volume 4 are annexes. These cover different sections within the pharmaceutical industry. For example, Annex 1, Manufacture of Sterile Medicinal Products, covering sterile drug manufacturing, was recently revised and released in August, 2022 with implementation starting August, 2023 (1 year). It is also the annex I am most familiar with.
The EudraLex – Volume 4 is equivalent to the FDA’s Title 21, but have important differences. For one, they use SI units versus Imperial units. I find that the EudraLex provides more direct guidance with more simple language. The FDA’s presents their’s to be up to interpretation. What differences do you find?