The pandemic put unprecedented pressure on drug and medical device production, underlining the growing challenge of monitoring, analyzing, reporting and acting on quality. It became clearer than ever before that the more fragmented processes become, the more critical it is that they can be assessed and managed for consistent quality. At the same time, innovative tools and best practices have emerged.
After a series of delays and false starts, EMA is now progressing its ISO IDMP agenda with firm intent. The first implementation guide is out now for consultation, to be followed by a second actionable version by next year. Life sciences companies targeting Europe will have a year to comply with all the measures—but this will be a lot of work.