For a new medicine to reach patients, it must achieve both regulatory marketing authorisation and reimbursement from the payer. Because regulators assess the benefits and risks of a medicine while the health technology assessment (HTA) bodies assess its value to the system, their informational needs differ. Two different but potentially aligned dossiers are therefore required: the regulatory dossier and the HTA submission dossier. The medical writer must be prepared to contribute to both. Herein we review the basic elements of the regulatory dossier, the Global Value Dossier and the HTA submission dossier. For the medical writer, an important challenge is how to determine whether there can be alignment and synergies between regulatory data and HTA data to support the respective decision-making processes. Practical approaches to the construction of the submission documents are provided here. These approaches bring consistency to the documents, serve as a checklist for relevant information, and facilitate the review by the assessor.
Editor-in-Chief
Co-Editors
Managing Editor
Victoria White
Associate Editors
Section Editors
Biotechnology
Digital Communication
EMWA News
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
In the Bookstores
Manuscript Writing
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Out on Our Own
Pharmacovigilance
Regulatory Matters
Regulatory Public Disclosure
Teaching Medical Writing
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Lay out Designer
Chris Monk