Regulatory Requirements
Applicable for the Pharmaceutical Industry
FDA as regulatory agency for US
In the dynamic field of pharmaceuticals, compliance with global regulatory requirements is crucial for ensuring product safety, quality, and efficacy.
The Food and Drug Administration (FDA) is the regulatory authority in the United States, and is responsible for safeguarding public health by ensuring the safety, effectiveness, and security of pharmaceutical products marketed in the country.
They establish guidelines and regulations for drug development, manufacturing, labeling, and distribution within the United States.
The FDA Quality guidance documents are of high significance for GMP manufacturer.
ICH as global regulatory agency
The International Council for Harmonisation (ICH) is a global organization that works towards harmonizing regulatory guidelines for the development, registration, and post-approval of pharmaceutical products.
The guidelines developed by ICH cover various aspects, including quality, safety, efficacy, and multidisciplinary considerations.
In the Word of Particle Analytical the ICH Guidellines Q6, Q8 and Q9 is of great importance,
EMA as regulatory agency for EU
The European Medicines Agency (EMA) is the regulatory agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union (EU).
They play a crucial role in the approval process of new drugs and oversee the post-approval safety. We all still can remember longing for the EMA approval of the Covid-19 vaccine.
Find the latest EMA approvals on medicial products here.
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