EMA releases guidance on medicine formulation strength
The European Medicines Agency (EMA) has released guidance defining the concentration of active ingredients in medicines marketed as being "strong" versions of a product.
The European Medicines Agency (EMA) has released guidance defining the concentration of active ingredients in medicines marketed as being "strong" versions of a product.
It has unveiled formulae helping manufacturers assess the strength of their medicines in EU market approval applications. For instance, with tablets or capsules, companies should measure the total active substance within a pharmaceutical; and with liquid preparations, companies should measure concentration of active ingredient.
EMA said that for main labels, strength declarations should henceforth be "based on user/prescription criteria, rather than on quality/analytical criteria", although detailed explanations on dosing should be included in product notes. It added: "The design applied by the pharmaceutical company should ensure the prominent and unambiguous identification of the key information for the correct use of the product".
It is supposed to "give the most relevant information" to aid a medicine's "use, easy identification and distinction from other presentations, and prescription by the physician", added the guidelines.
That said, EMA stressed that decisions on the most appropriate "strength" should still be taken on a case-by-case basis, albeit following its general advice. It added that percentages should not express strength, except for authorised medicinal products (or a new strength of such products) sold with percentages in the past.
