EMA Provides an Outlook on the Product-Specific Bioequivalence Guidelines Expected in 2026
Recommendation
Tuesday, 10 November 2026 9 .00 - 17.00 h
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
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.
Related GMP News
05.11.2026Eurachem Publishes Webinar Recording on the Fitness for Purpose of Analytical Methods Guide
05.11.2026Recent Publications Highlighting Topics to be Discussed at PharmaLab 2026
05.11.2026Meet the AQCG Board Members at PharmaLab 2026
05.11.2026FDA Warning Letter: When Test Procedures Allow Retesting Until an Acceptable Result is Obtained
21.10.2026EMA Updates Information Page on Bioequivalence Guidelines
21.10.2026BP Publishes new Draft Texts