What’s in, what’s out, what’s relevant? – Towards a sensible label At the June 20th workshop of the Regulatory Science Netwerk Nederland (RSNN), we will gather experts from academia, the patient community, regulatory authorities, the (bio)pharmaceutical industry and the medical profession, to share experiences and explore regulatory improvement opportunities for the label.
The Summary of Product Characteristics of a pharmaceutical product (SmPC, or the ‘label’) is a key document in the regulatory process and reflects the outcomes of the discussions between regulatory authorities and the (bio)pharmaceutical industry (the applicant). The label serves as a basis of information for many other documents, such as patient leaflets and physician handbooks. A wide range of indirect ‘users’ of the label are thus exposed to the information contained in it, and not exposed to information not contained in the label. These indirect users are excluded from the interactions between an applicant and the regulatory authorities that shape the content of the label.
Evolving scientific insight into a medicinal product’s benefit/risk profile does not always find its way into the label. No formal regulatory pathway exists, for example, for including clinically meaningful research results in the label that are generated by independent academic groups or clinicians. On the other hand, some information currently included in the label may not be considered relevant for the intended patient population by some stakeholders.
What’s in the label, what’s out, what’s relevant? During the RSNN workshop on June 20th, we will discuss the information that would ideally be included in the label to match patients’ and prescribers’ needs. Additionally, we will consider the current challenges with amending an existing label. The identified gaps in the content of the label, and the restraints in the possibilities to amend the label, are expected to serve as the basis for the workshop discussions and potential future research in the field of regulatory science.
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Laan van Nieuw Oost-Indië 131-133
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Laan van Nieuw Oost-Indië 131 E
2593 BM Den Haag