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  2. List of Guidances for Statistics in Regulatory Affairs

    en.wikipedia.org/wiki/List_of_Guidances_for...

    ICH E6(R2): Good clinical practice [1] is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. FDA: Good Review Practice: Clinical Review of Investigational New Drug Applications. [2]

  3. Guidances for statistics in regulatory affairs - Wikipedia

    en.wikipedia.org/wiki/Guidances_for_statistics...

    This directive provides guidelines for ensuring the highest standards of quality and integrity in clinical research. In the European Union, a parallel guideline exists for clinical trials involving medical devices. This guideline is known as the international standard ISO 14155, and it serves as a harmonized standard within the European Union ...

  4. European Medicines Agency - Wikipedia

    en.wikipedia.org/wiki/European_Medicines_Agency

    The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. [8]

  5. European Directorate for the Quality of Medicines & HealthCare

    en.wikipedia.org/wiki/European_Directorate_for...

    The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).

  6. Good laboratory practice - Wikipedia

    en.wikipedia.org/wiki/Good_Laboratory_Practice

    The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]

  7. International Council for Harmonisation of Technical ...

    en.wikipedia.org/wiki/International_Council_for...

    In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.

  8. GxP - Wikipedia

    en.wikipedia.org/wiki/GxP

    GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP. A "c" or "C" is sometimes added to the front of the initialism.

  9. European Centre for Disease Prevention and Control - Wikipedia

    en.wikipedia.org/wiki/European_Centre_for...

    Former seat of ECDC, the Tomteboda School, Solna As EU economic integration and open frontiers increased, cooperation on public health issues became more important. While the idea of creating a European centre for disease control had been discussed previously by public health experts, the 2003 SARS outbreak and the rapid spread of SARS across country borders confirmed the urgency of the ...