CRED 8 Presentations

01/07/2024

Common objections regarding WEU applications

• The applicant has not demonstrated that the active substance in the claimed therapeutic indication has been in well-established medicinal use within the Union for at least ten years, with recognised efficacy and an acceptable level of safety (see Chapter 1 of Volume 2A of the NtA).  Medicinal use outside the Union cannot be used. Waiver for this requirement is not possible, e.g. for diseases that are not an endemic disease in the Union.  Reference to treatment Guidelines not sufficient. Actual data on use in the Union needed • Bridging data to the products described in literature have not been provided.  Bridging should be direct data versus product described in literature related to the pivotal studies or comparison with a product representative for product used in literature.  In case no information is available on the composition used in literature an application based on WEU might not be feasible • The applicantuses data from literature which stillfall under data exclusivity

The Organisation for Professionals in Regulatory Affairs

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Generic/hybrid applications-important points to take into account:

 Legal basis chosen e.g. different salt compared to reference product: 10(1) or 10(3)?  Choice Reference product in all MSs (should belong to the same GMA for RMS and CMSs)  Abridged applications of chemically manufactured generics of innovator products (recombinant manufacturing process); e.g. teriparatide, which legal basis is appropriate  Non- EU reference products (NB UK not an EU MS anymore!) not acceptable also bio-equivalence study should be performed with reference product sourced in the EU  Whether data exclusivity period has expired NB: Not possible to change the legal basis/Reference product after start of the procedure!

The Organisation for Professionals in Regulatory Affairs

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