Introduction - Uppsala Monitoring Centre

Despite these actions the prescribers may not heed them and the regulatory
authority will be forced to withdraw the drug, e.g. amidopyrine, bromfenac, cisapride,
ebronidine and troglitazone (Smalley, 2001; NAO 177 , 2003). The whole area of
regulatory response to adverse events was secret ‘The CSM’s policy on nondisclosure
of adverse drug reaction data, agreed at a meeting in June 1989, is itself
an official secret’ (Medawar, 1990); ‘data handled by regulatory authorities are
highly confidential.’ (Hancher, 1989). The confidentiality laws are included within the
1968 Medicines Act.
Regulatory authorities
The dates when different countries have undertaken some kind of control of drugs
on the market have been given earlier in the book, but for many countries it is
unknown. Many of the drugs mentioned in Part 3 were removed after 1960 and their
removal from a specific market depended on whether there was an active regulatory
authority in that country at the time of the drug problem. As a marker for the date
when a country’s regulatory system was viable I have taken the year of entry to the
WHO programme. For those countries where there was an active system prior to
joining the WHO programme the earliest date known for that country is in brackets.
1968: Canada (1965), Denmark, Germany (1958), Ireland, Netherlands (1963),
Sweden (1934), UK, USA (1938)
1971: Norway (1928)
1972: Poland, Japan
1973: Israel
1974: Finland (1966), Yugoslavia
1975: Italy, Bulgaria
1976: Romania
1977: Belgium
1984: Spain, Thailand
1986: France (1975)
1987: Turkey
1990: Greece, Hungary, Iceland, Malaysia, Indonesia
1991: Switzerland, Australia, Austria, Costa Rica
1992: South Africa, Republic of Korea, Morocco, Croatia, Czech Republic
1993: Tunisia, Portugal, Singapore, Slovakia, Tanzania
1994: Cuba, Argentina
1995: Oman, Philippines, Venezuela
1996: Chile
1997: Bangladesh set up an ADR advisory committee.
177 NAO = National Audit Office (UK)