CRED NPM

05/11/2024

Challenges in the German switch process

Process not optimal

• Application 2x a year, overall timeline sometimes difficult to predict • Limited involvement of applicant, decisions sometimes not transparent

Improvement 2020: Right to be heard for applicant, BfArM scientific opinion provided to applicant

No product-specific switch

• OTC status granted for all MAs, which fulfill conditions

• Can be a challenge in case of unharmonized labelling for DCPs

Limited market exclusivity

The Organisation for Professionals in Regulatory Affairs

17

Sucessful Triptan Switches in Germany

Year

Active ingredient

2006

Naratriptan

2009

Almotriptan

2020

Sumatriptan (tablets)

2024

Rizatriptan

The Organisation for Professionals in Regulatory Affairs

18

9