FDA Approved

Regulatory agencies perform a number of important roles in the pharmaceutical industry. Among the most important is that of ‘Watchdog’, ensuring that pharmaceuticals entering a given market meet the required safety and efficacy standards. Included among the responsibilities that these agencies assume are:

  1. Assuring that ethical standards are adhered to for human and animal testing e.g. Good Clinical Practices (GCP).
  2. Ensuring that Good Manufacturing Practices (GMP’s) are adhered to by domestic manufacturers.
  3. Verifying that drugs entering the territory of responsibility have been manufactured under GMP-compliant conditions.
  4. Assessing whether drugs entering the territory of responsibility meet the required quality, efficacy & safety standards.
  5. Protecting against counterfeit medicines.

While not an extensive list, these responsibilities highlight the critical importance of these agencies in securing the safe supply of drugs to the public.

This section of CaribbeanBiopharma.com will therefore support dissemination of information on Pharmaceutical Regulations.


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