Regulatory Agencies Flashcards
Who are MHRA and what are they responsible for?
Medicines and Healthcare products Regulatory Agency
An executive agency of the department of health and social care in the united kingdom which is responsible for ensuring that medicines and medical devices work and are acceptable safe.
Who are EMA and what are they responsible for?
European Medicines Agency.
A centralized agency of the European Union responsible for evaluating the marketing authorization of drug products
Who are PIC/S?
A collaborating regulatory agency of 40 participating health authorities that leads the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products
Who are PMDA and what are they responsible for?
Pharmaceuticals and medical devices Agency.
An independent administrative institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan.
Who are FDA and what are they responsible for?
United States Food & Drug Administration.
A federal agency responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics and products that emit radiation
What are HPRA and what are they responsible for?
The Ireland Health Products Regulatory Authority.
A government agency that used scientific and clinical expertise to review and monitor health products pertaining to people and animals, available in Ireland or exported abroad
Who are ICH and what do they do?
International conference for harmonisation.
A collaborative effort to bring regulatory authorities from Europe, Japan and the united states as well as industry experts together to facilitate discussions on the scientific and technical aspects of the product lifecycle
