|
|
 |
| Your
monthly regulatory affairs update |
|
{Anrede},
Welcome to the July 2025 edition of our Regulatory Affairs Newsletter.
In this issue, we provide you with a comprehensive overview of the key regulatory developments from the past few weeks. In addition, you find a summary and partial feedback from participants of the German-language seminar “GMP meets AI: Increasing efficiency with ChatGPT & Co.“ on June 24, 2025, experts: Dr Karl-Heinz Bauer and Dr Cornelia Hunke.
If you have any requests or suggestions, please feel free to contact us. We look forward to hearing from you!
|
|
|
 |
Editorial |
|
|
News from ICH |
|
|
News from European Commision |
|
|
News from CMDh |
|
|
News from EMA |
|
|
News from BfArM and PEI |
|
|
Veterinary news |
|
|
Monthly reports |
|
|
|
|
|
|
|
|
Editorial
|
|
„GMP meets AI: Increasing efficiency with ChatGPT & Co.“ on June 24, 2025
Artificial intelligence meets regulatory practice: a seminar that shows new ways.
How can modern AI tools such as ChatGPT, Claude or Gemini be used sensibly and in compliance with regulations in the strictly regulated GMP environment? This central question was the focus of the 1-day online seminar. […]
... Read more
Don’t miss the “second edition” of the German-language course “GMP trifft KI: Effizienzsteigerung mit ChatGPT & Co.“ on December 9, 2025.
Details
|
|
|
|
|
|
|
|
|
News from ICH |
|
The ICH E20 Draft Guideline on “Adaptive Design for Clinical Trials” has reached Step 2b of the ICH Process on 25 June 2025 and has entered the public consultation period.
Details
The ICH E21 draft Guideline on “Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials” reached Step 2b of the ICH Process in May 2025 and has entered the consultation period.
Details
|
|
|
|
|
|
|
|
|
|
|
|
News from European Commision |
|
The Stakeholders’ Consultation on EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 4, Annex 11 and New Annex 22 has started and is open until 07 October 2025.
Details
As an employee in Regulatory Affairs/CMC, would you like to master cooperation and communication at the interface with the quality department safely, efficiently and sustainably? Knowledge of quality-relevant facts, basic GMP knowledge and knowledge of the processes at the interface are essential for this.
Get all the necessary essentials during the German-language seminar “GMP- und Qualitäts-Know-how für Regulatory Affairs/CMC” on 11-12 November 2025.
Details
The Commission invites health stakeholders to submit proposals for a new cycle of Thematic Networks under the EU Health Policy Platform. The deadline for submissions is 22 August 2025.
Details
As part of the COMBINE programme, the European Commission and EU Member States have launched a pilot project to test a new, more efficient way of approving combined studies.
Details
|
|
|
|
|
|
|
|
|
|
|
|
|
News from CMDh |
|
The CMDh summarises the information on the new Variation rules:
Following the revision of the Variation Regulation applicable since 1 January 2025, the European Commission (EC) has now published a draft version of the new EC guidelines on the details of the various categories of variations and operation of the procedures.
The EC expects these guidelines to apply from 15 January 2026, as provided in the published draft version of the Variations Guidelines.
Details
Our seminar "Variations in Europe" on 08-09 September offers an in-depth understanding of the regulatory landscape. Our expert team will provide insights into the variation regulation, submissions, quality-related changes, and all practical implications of the 2025 update.
Details
| |
|
|
|
|
|
|
|
|
|
News from EMA |
|
EMA and the HMA has published a recommendation paper to address vulnerabilities in the supply of critical medicines used during pregnancy.
Details
The Network Data Steering Group (NDSG) published recommendations for human Product Master Data implementation and data management.
Details
EMA published its annual activity report for 2024.
Details
EMA published an infosheet with a review of real-world data studies from September 2021 to February 2025.
Details
The use and “impact” of Real World Data (RWD) during the development of herbals is one of the hot topics of the online conference “Hot Topics Related to Quality in Herbal Medicinal Products” on November, 27 2025.
Details
The revised chapter 9 of the Guideline on epidemiological data on blood transmissible infections can be commented on by 31 August.
Details
The concept paper on the new reflection paper on the clinical investigation of medicinal products for the treatment of Systemic Sclerosis can be commented on by 30 September.
Details
The PLM Portal FHIR XML has been upgraded to version 2.2.3. The next update (version 2.2.4), planned for the end of July 2025, will modify all FHIR message links from HTTPS to the recommended HTTP protocol.
Details
The electronic Common Technical Document (eCTD) v4.0 team is pleased to launch Step 2 of the eCTD v4.0 Technical Pilot, for Centrally Authorised Products (CAP).
Details
Get the latest news on EMA-IT systems, IDMP/PMS and eCTD also in this training: Regulatory Submission Update.
Details
|
|
|
|
|
|
|
|
|
|
News from BfArM and PEI |
|
The COMBINE 1 ‘all-in-one’ pilot project starts: Call for participation is open until 31 August 2025.
Details
The newest bulletin on drug safety (German-language) has been published.
Details
|
|
|
|
|
|
|
|
|
|
Veterinary news |
|
The concept paper on the need for Revision of the Note for Guidance on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water can be commented on by 31 Octobre 2025.
Details
|
|
|
|
|
|
|
|
|
|
|
|
Kind regards,
|
Jean-Marie Bayhurst
Your contact for
Regulatory Affairs (Human)
+49 6221 500-685 |
Dr C. Michaela Gottwald
Your contact for
Regulatory Affairs (Veterinary)
+49 6221 500-610 |
Dr Birgit Wessels
Your contact for
CMC
+49 6221 500-652 |
|
Verena Planitz
Your contact for
Global Regulatory Affairs
+49 6221 500-655
|
|
|
|
|
|
