UK's MCA To Drop Data Sheets

16 October 1994

Britain's Medicines Control Agency has indicated that it will abolish the need for data sheets to be produced by pharmaceutical companies for their products. Instead, drugmakers will be required to provide Summaries of Product Characteristics, which are already submitted with all new drug approval applications under European Union's procedures.

The objective is to avoid duplication and to rationalize the present situation where a company is required to produce two separate but similar information sheets in order to comply with existing regulatory requirements. A letter from the MCA to "interested organizations" says this measure, which is to be the subject of consultations with pharmaceutical trade and medical representatives, is expected to reduce the cost to industry by removing a duplicate requirement. The estimated cost of preparing and distributing a data sheet for a single product is in excess of L30,000.

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