Final answer:
In 2009, the FDA adopted the ICH Guidelines to harmonize global pharmaceutical regulations, ensuring safety, quality, and efficacy of medicines and aligning FDA's practices with international standards to streamline drug development and registration.
Step-by-step explanation:
In 2009, the FDA, in an attempt to embrace global harmonization, adopted the ICH Guidelines.
The ICH (International Conference on Harmonisation) works towards uniform standards for the pharmaceutical sector, which helps in ensuring the safety, quality, and efficacy of medicines.
This move towards harmonization benefits international trade and regulation as it creates consistent standards for drug development and registration in different countries, streamlining the process and aiding scientific breakthroughs.
It was a significant step as it aligned the FDA's regulations closer with international partners, intending to facilitate a more effective and efficient regulatory framework for medicines globally.
It is also a reflection of the need for scientific bases in regulations mandated by the WTO rules, which require that health and safety standards must not discriminate between countries arbitrarily, particularly when identical or similar conditions prevail.
These guidelines cover various aspects, including clinical trials (E8), validation of analytical procedures (Q2), and safety studies (CPMP/ICH/286/95), among others.