Swissmedic updates regulations on drug information changes for manufacturers

Swissmedic has published amendments to regulations for drug manufacturers when highlighting changes to manuscripts of medicinal product information relating to their products.

The Swiss Agency for Therapeutic Products, which regulates medicines in the European country, says drugmakers will now be required to make changes to such documents entirely electronically, using Microsoft Word’s ‘Track Changes’ function, as the agency itself has been doing when processing these manuscripts since April 2015.

Effectively, this outlaws other forms of highlighting, such as colored highlighting and text strike- throughs, in the documents giving information on medicines to healthcare professionals including doctors, and also patients. The agency says the adoption of these standards will ensure “efficient working”.