A discussion paper(1)

Conditional release is the approval of a new drug onto the market, subject to specific conditions that, if achieved, will lead to full approval. The conditions may relate to effectiveness and/or safety but are not necessarily limited to these factors. The conditional approval for the marketing of a new drug, during which time the product is used in normal medical practice (rather than the highly selective world of randomized clinical trials), should allow the collection of data on effectiveness and safety to provide information for a real cost effectiveness evaluation. asthma inhalers

Conditional release is not a new concept. Schemes to monitor the safety of new drugs that included conditional approval of the drugs were proposed over 20 years ago when the United Kingdom postmarketing voluntary reporting system failed to identify the adverse effects of practolol. Only four reports of psoriasis and one of conjunctivitis were submitted to the Committee on Safety of Medicines before the publication of reports linking practolol with a psoriasiform rash , a ‘dry-eye’ syndrome that could lead to blindness and an unusual form of peritonitis that could lead to death . Following these publications, the Committee on Safety of Medicines received more than 200 notifications of patients with eye reactions, a larger number with skin reactions, and almost 40 cases of sclerosing peritonitis, most relating to observations made many months, even years, previously (Because therapeutics in North America were some six to seven years behind European therapeutics , practolol was not approved for maketing on this continent in 1974).