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25 January 2018

Essentials of European Pharmaceutical Regulatory Affairs

Setting the Scene

Dolorès Edmont, L2D Consulting 34 Telmar Hodzi, Regulatory Affairs Officer

ENABLINGANDPROMOTINGEXCELLENCE INTHEHEALTHCAREREGULATORYPROFESSION

How Regulations Arise

In This Presentation We Will Cover

 How regulations arise  EU Legislations  Medicinal Products - definition  Medical devices - definition  Key Directives, Regulations, Guidelines  EU Regulatory Bodies  ICH

How Regulations Arise As with most laws, the rules are often written or tightened in response to one or more disasters: 1937 - Elixir of Sulfanilamide - USA ● Food and Drugs Act (1938) 1957 - Introduction of Thalidomide ● FDA introduced tightened approval requirements, regulation of advertising, and GMP inspections (1962) ● UK Committee on Safety of Drugs (1963) ● European Medicines Directive (1965) ● UK Medicines Act (1968) 1980-1990 – the contaminated Blood affair ● French Health Agency (Agence du médicaments (1993), Afssaps, then ANSM)

EU Legislations

Types of legislation  Primary legislation… TREATIES

 Secondary legislation  REGULATIONS… immediate effect  DIRECTIVES… to Member State laws  DECISIONS… binding on organisations  RECOMMENDATIONS/OPINIONS

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