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1. academic.oup.com › jmp › articleOn Drugs | The Journal of Medicine and Philosophy: A Forum ...

   academic.oup.com › jmp › article

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   Jun 23, 2023 · III. PHARMACOLOGICAL DEFINITIONS. A basic definition of medical drugs should thus include all the substances taken to be medical drugs and exclude all the substances that are not. An obvious place to begin our search for an overarching definition of the drug concept is pharmacology.

2. www.ncbi.nlm.nih.gov › pmc › articlesDefinition and Classification of Generic Drugs Across the World

   www.ncbi.nlm.nih.gov › pmc › articles

   Jun 20, 2015 · Our aim was to systematically identify and compare how generic medications, as defined by the US Food and Drug Administration (FDA), World Health Organization (WHO), and European Medicines Agency (EMA), are classified and defined by regulatory agencies around the world.

   • Author: Rafael Alfonso-Cristancho, Tatiana Andia, Tatiana Barbosa, Jonathan H. Watanabe
   • DOI: 10.1007/s40258-014-0146-1

   • Publish Year: 2015
   • Published: 2015

3. People also ask

   What makes the European medicines regulatory system unique?

   • The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 30 EEA countries (27 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA. This network is what makes the EU regulatory system unique.

   The European Regulatory System for Medicines

   www.ema.europa.eu/en/documents/leaflet/european-regulatory-system-medicines_en.pdf

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   What is a'substandard' drug?

   • In 2009, the World Health Organization (WHO) defined ‘substandard’ drugs (also called ‘out of specification products’) as ‘genuine medicines produced by manufacturers authorized by the NMRA [national medicines regulatory authority] which do not meet quality specifications set for them by national standards’ [ 6 ].

   Substandard drugs: a potential crisis for public health - PMC

   www.ncbi.nlm.nih.gov/pmc/articles/PMC4137817/

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   What is a substandard medicine?

   • Substandard medicines are pharmaceutical products that do not meet their quality standards and specifications.’ The WHO defines ‘counterfeit’ drugs as ‘medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source’ [ 8 ].

   Substandard drugs: a potential crisis for public health - PMC

   www.ncbi.nlm.nih.gov/pmc/articles/PMC4137817/

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   Are substandard drugs affecting the effectiveness of drugs?

   • Effective drugs are now available for some of the most prevalent and destructive diseases in the developing world, including tuberculosis, malaria and HIV/AIDS. However, the effectiveness of drugs in treating these diseases, as well as many other illnesses, is compromised by the distribution of substandard drugs.

   Substandard drugs: a potential crisis for public health - PMC

   www.ncbi.nlm.nih.gov/pmc/articles/PMC4137817/

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4. www.ncbi.nlm.nih.gov › pmc › articlesHow defensive medicine is defined in European medical ...

   www.ncbi.nlm.nih.gov › pmc › articles

   Jan 20, 2022 · BMJ Open. 2022; 12 (1): e057169. Published online 2022 Jan 20. doi: 10.1136/bmjopen-2021-057169. PMCID: PMC8783809. PMID: 35058268. Original research. How defensive medicine is defined in European medical literature: a systematic review.

   • DOI: 10.1136/bmjopen-2021-057169
   • Published: 2022

   • Publication: BMJ Open. 2022; 12(1): e057169.

5. www.ncbi.nlm.nih.gov › pmc › articlesSubstandard drugs: a potential crisis for public health - PMC

   www.ncbi.nlm.nih.gov › pmc › articles

   Nov 29, 2013 · In 2009, the World Health Organization (WHO) defined ‘substandard’ drugs (also called ‘out of specification products’) as ‘genuine medicines produced by manufacturers authorized by the NMRA [national medicines regulatory authority] which do not meet quality specifications set for them by national standards’ [ 6 ].

   • Author: Atholl Johnston, David W. Holt
   • DOI: 10.1111/bcp.12298

   • Publish Year: 2014
   • Published: 2014/08

6. onlinelibrary.wiley.com › doi › 10Different regulatory framework for medical devices and drugs ...

   onlinelibrary.wiley.com › doi › 10

   Jun 14, 2023 · Different regulatory framework for medical devices and drugs in the European Union: Impact on clinical research and health technology assessments - Albuquerque de Almeida - The International Journal of Health Planning and Management - Wiley Online Library.

7. www.tandfonline.com › doi › fullInsights into the definition of terms in European medical ...

   www.tandfonline.com › doi › full

   Aug 25, 2016 · The aim is to give insights on the correct definition these terms in order to contribute to build the desired synergy between scientific and regulatory fields and promote a correct interpretation of the European regulatory framework as well as sustainable health and innovation.

8. www.ema.europa.eu › en › documentsThe European Regulatory System for Medicines

   www.ema.europa.eu › en › documents

   The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 30 EEA countries (27 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA. This network is what makes the EU regulatory system unique. The network is supported by a pool of over 4,000 experts drawn ...