Introduction - Uppsala Monitoring Centre

These postulates governed toxicological work for the following
decades. Some of the drug disasters that followed were because of
neglect of these principles (Hodel & Bass, 1992).
The Food and Drugs Act (UK) made it illegal to sell a drug labelled in
a misleading way or to publish an advertisement which did so
(RPSGB).
1939 An improved standard for measuring the safety margin for drugs was
proposed, based on the determination of the dose-effect relationship.
The ‘standard safety margin’ was defined as the zone between the
surely effective dose and the lowest lethal dose (Foster, 1939).
1941 First patient treated with penicillin (Ellis 1997).
The major French law of 11th September 1941 on pharmacy
stipulated in article No.1: the preparation of medicines intended for
use in human medicine are reserved to pharmacists.
The UK Pharmacy and Medicines Act legislated against ‘secret
remedies’ making the disclosure of the active drugs compulsory. ‘Not
derived primarily from a concern to protect consumers’ interests, but
rather from the conflicts of interest within the drug trade with respect
to tax exemptions and related privileges.’ (Abraham, 1995).
The Winthrop Chemical Co. despatched 12 shipments of
sulfathiazole, which contained no sulfathiazole, but were filled with
phenobarbital. Eighty-two people died. The same tabletting machine
had been used for both drugs.
1943 February: Nazi government banned all new drugs except those
granted special approval by Defence Ministers (Stop-Verornung).
This ban continued on into the 1950s (Abraham & Smith, 2003).
The Drafting of the French Pharmacopoeia was placed under the
jurisdiction of a National Pharmacopoeia Commission under the
authority of the Minister of Public Health (Kassel,1996).
The Japanese ‘Pharmaceutical Affairs Law’ was introduced to
implement regulations necessary for ensuring the quality,
effectiveness, and safety of drugs and medical devices.
Streptomycin discovered by Dr Selman Waksman’s team from
Rutgers University (see under marker drugs).
1946 The UK Medical Research Council set up the first formal randomised
control trial (see under marker drugs).
1948 First modern randomised clinical trial of streptomycin/placebo by the
Medical Research Council (MRC). This reported damage to the inner