Abstract
The aim of regulation in drug safety is to state as clearly as possible and to enforce the legal responsibility of the involved parties (regulators, marketing authorization holders and health care professionals where applicable), and to provide guidance on how the respective duties should be complied with. The guidelines issued have as a significant impact on the outcome as the law itself, as they determine the stakeholders’ compliance and performance.
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- 1.
Pharmaceutical regulation up to the middle of the twentieth century focused mainly on manufacturing and sales issues, documentation of efficacy, as is standard nowadays, was not required. A medicine was considered unsafe if contaminated with known toxic agents, but the concept that an active ingredient itself could cause damage to certain patients was not current.
- 2.
The US Food and Drug Administration (US FDA) did not approve thalidomide due to safety concerns, which leads to the conclusion that data pointing at a safety issue were available at the time.
- 3.
The program started in 1968 with 10 countries willing to share their reports on adverse reactions to medicines and counts 121 full members and 29 associate member as per September 17th 2015. For further information see http://www.who-umc.org/DynPage.aspx?id=98080&mn1=7347&mn2=7252&mn3=7322&mn4=7324
- 4.
Temafloxacin was licensed in Europe and Latin America at the end of 1991. Shortly after approval by the US FDA in February 1992 serious, and in some cases fatal ADRs describing a multiorgan disease involving the hematological, hepatic and renal systems were reported with alarming frequency. After several meetings with the US FDA, the MAH agreed to withdraw the drug On June 5th 1992. Between February and June the sales representatives were not only not informed about the discussions with the regulators but pushed to continue selling the product, according to J. O’ Donnell in his book Drug Injury. Liability, Analysis and Prevention, 1st ed 2001. The withdrawal was followed by several claims of wrongful death and personal injury filed in the USA and not settled until 1997.
- 5.
In 2002 Switzerland introduced the legal requirement for HCP to reports ADRs and this was broadly communicated to the medical community. The number of reports from HCPs increased rapidly over a short time. When the authority stopped actively promoting ADR reporting on a large scale, the number of reports stabilized more or less, while reports from industry kept increasing significantly. See https://www.swissmedic.ch/ueber/00134/00441/00445/00568/index.html?lang=en
- 6.
The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency is composed of representatives of the Member States, scientific experts and one representative of healthcare professionals and of patients’ organizations respectively. http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000537.jsp
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Caduff-Janosa, P. (2017). Lost in Regulation. In: Edwards, I., Lindquist, M. (eds) Pharmacovigilance. Adis, Cham. https://doi.org/10.1007/978-3-319-40400-4_2
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DOI: https://doi.org/10.1007/978-3-319-40400-4_2
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