In total, EMA published four draft documents this week. Two of the documents address aspects of communicating with HCPs. EMA is proposing multiple changes to the template letter used by marketing authorization holders (MAHs) to inform HCPs of safety concerns. Many of the changes amount to a reordering of existing elements, but EMA has also added new lines, such as the need to frame the alert in the context of the therapeutic indication.
EMA has also provided a communication plan and checklist to guide MAHs through the process of informing HCPs of safety issues. The plan recommends that when multiple companies are authorized to market the same active pharmaceutical ingredient, the businesses collaborate to craft one letter each of them can send to HCPs. EMA also offers advice on the value of using the title of the letter to outline the safety concern.
Further guidance on safety communication is provided in an updated version of module XV, a text that goes into greater detail about the structures and processes used in communications about the safety of products. EMA has made multiple changes to the text, which now places greater emphasis on the need to deliver “relevant, clear, accurate and consistent messages” while also softening language about the use of graphical presentations of the risk posed by a product.
The final draft document proposed by EMA covers specific considerations for biologics. EMA wants to update the text to reflect the release of other documents of relevance, such as the Guideline on Similar Biological Medicinal Products. All of the documents are open for comment until the end of February. EMA then plans to make any necessary changes quickly and have final texts in place by the end of the second quarter.
More Information on RAPS