EMA Provides an Outlook on the Product-Specific Bioequivalence Guidelines Expected in 2026
Recommendation
6/7 October 2026
Dealing with different compendial methods
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
28.09.2026The Relationship between the BP and the Ph. Eur.
28.09.2026New Japanese Pharmacopoeia Drafts (September 2026) Open for Public Comment
28.09.2026EMA publishes final ICH M13B Guideline and Q&A on Bioequivalence
16.09.2026USP-NF Publishes Responses to Comments on Stimuli Article on Apex Vessel Geometries