Module 18 - Drug Device Combinations and Other Technologies

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MODERN ERA: INCIDENTS THAT HAVE HARMED PATIENTS…

Year

Region

Product and Harm Consequent Legislation

1937

USA

Sulphanilam ide syrup (100 deaths)

US 1938 Food,Drugsand C osm etics A ct

1959

EUROPE

Thalidom ide (foetalabnorm alities)

EU Directive 65/65/EC UK 1968 M edicinesAct

2008

USA & partsofEU Heparin adulteration (81+ deaths)

US 2012 Food and Drug Adm inistration Safety and Innovation Act(FD ASIA) EU Directive 2011/62/EU (FM D)

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TO MINIMISE POTENTIAL PATIENT HARM MEDICINES ARE REGULATED BY LAW

Intrinsic Quality factors

• Safety • Efficacy

MUST DEMONSTRATE:

Extrinsic Quality factors

• Quality, made to GMP

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