Request for consultation in accordance with SGB V section 35a with the participation of the BfArM
Since the introduction of the Act on the Reform of the Market for Medicinal Products (AMNOG) in Germany in 2011, new medicinal products with the new active substances are required to undergo an early benefit assessment immediately after market entry. Pharmaceutical companies can request consultation by the G-BA on documents and studies to be submitted (SGB V, section 35a, paragraph 7). A consultation before the start of phase 3 authorization studies should involve the BfArM. The pharmaceutical company must pay the costs of the consultation.
Conversely, upon request experts from the G-BA can be involved in the consultation meeting at the BfArM.
More information about the procedure and relevant documents can be found on the webpage of the G-BA: http://www.english.g-ba.de/benefitassessment/information/#9 and in the Guidance for Applicants.