Member: Daniela Elena Popa National Medicines Agency and Medicinal Devices of Romania48, Aviator Sanatescu Street, Sector 1011478 BucharestRomania

The version allows the selection of Reference Member State and Concerned Member State(s) when the type of authorisation is “National Authorisation” and the type of application is “Super-grouping”.

The ICH Q1 draft Guideline on "Stability Testing of Drug Substances and Drug Products" reached Step 2b of the ICH Process on 11 April 2025 and entered the public consultation period.

As ICH celebrates its 35th anniversary in 2025, DIA proudly honors its extraordinary impact on global health.

The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.9 reached Step 4 of the ICH process in March 2025.

In follow up to the publication of the ICH M11 Updated Technical Specification (TS) in March 2025, the M11 EWG has also prepared a Step 2 informational presentation.

Further guidance on eSubmissions can be found on the EMA website under eSubmission

The ICH M13B draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Additional Strengths Biowaiver reached Step 2b of the ICH Process on 13 March 2025 and entered the public consultation period.

The ICH M11 updated version of the Technical Specification document, which incorporates comments received during the first public consultation, reached Step 2b of the ICH process in March 2025 and now enters the second round of public consultation.

Act-HIB (Haemophilus type b conjugate vaccine (adsorbed))End of procedure: 21/10/2024Date of publication: 05/03/2025