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EMA Provides an Outlook on the Product-Specific Bioequivalence Guidelines Expected in 2026
Recommendation
23/24 June 2026
Development / Quality Control and in vivo Relevance
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EMA’s product-specific bioequivalence guidances describe, in a standardised format, how bioequivalence (BE) should be demonstrated.
On 19 May 2026, the EMA added the item “Product-specific guidelines that can be expected for 2026” to its website.
The following products are listed:
- Aripiprazole
- Cladribine
- Etonogestrel
- Fidaxomicin
- Ivacaftor
- Liraglutide
- Naproxen
- Niraparib
- Piribedil
- Raltegravir
- Rifaximin
- Semaglutide (tablets + SC solution)
- Tafamidis
- Tofacitinib
Further information is available on the EMA website.
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