Regulatory Affairs

Author: Dr Henriette Wolf-Klein

On 11 May 2026, the webcast 'Accelerating Authorisation Procedures in Europe' took place, with Ms Beate Schwalenberg as the speaker.
 
In the first part of the webcast, Ms Schwalenberg provided information on the recent restructuring of the BfArM (Federal Institute for Drugs and Medical Devices). The most significant change was the dissolution of the decentralised structure of procedure management within authorisation divisions 2, 3, and 4, as well as division 7, in favour of a single, centralised procedure management unit within division 4.

Division 4 now comprises five units:

• Unit 41 has two main areas of work: a. regulatory IT and b. a coordination office. Through this coordination office, the requirements of the Medical Research Act for a central interface between BfArM and PEI have been implemented. Work is ongoing to achieve greater harmonisation of procedures between the two authorities and to intensify their exchange. Joint applications for rapporteurships are already taking place, along with mutual support in cases of resource bottlenecks.
• Unit 42 takes on project management and the coordination of all MRP and DCP procedures.
• Unit 43 handles Type IA variations and national change notifications. Validation of variations also takes place here. All other validations (authorisation procedures and further variation types) have remained in division 1.
• Unit 44 manages the procedure handling for Type IB and Type II variations. Renewals are currently also located here, but are expected to be phased out under the EU Pharmaceutical Legislation.
• Unit 45 takes a holistic approach to all topics relating to centralised procedures. This also applies to PRAC procedures, which have been moved from the PV into division 4.

 
In the second part of the webcast, it became clear how many open implementation questions remain regarding the EU Pharmaceutical Legislation. The overarching goal is to shorten the duration of the various authorisation procedures.
One topic that was discussed in depth was the opt-in mechanism: in the future, member states will be able to join both MRP and DCP procedures within 30 days if a supply shortage exists. Whether and who must provide proof of the supply shortage remains unclear.
Overall, Ms Schwalenberg emphasised that the restructuring at BfArM has so far put the authority on a good track to effectively implement the upcoming regulatory requirements as well.

Author: Dr Birgit Wessels

On 18 March 2026, Dr Cornelia Hunke, Head of the Quality and Risk Management Department at the Evangelical Hospital Göttingen-Weende and a consultant for GxP and ISO, led an on-site in-house training lecture on the topic of “Artificial Intelligence in GxP”.
 
Under the guiding principle “Quality over Hype: Using AI and Digital Tools in Compliance”, Dr Hunke first provided a comprehensive overview of current digitalisation trends in the pharmaceutical and medical industries, including cloud infrastructures, automation, digital health, and the growing use of AI in drug development. She made it clear that digitalisation and AI are tools, not magic bullets, and that their use does not improve unstructured processes; at best, they simply lead to chaos more quickly.

A key topic of the presentation on regulatory issues was the EU AI Act, whose requirements will apply from 2026, particularly to high-risk AI applications in the pharmaceutical and medical sectors, and which requires, among other things, sound AI expertise and demonstrable oversight at management level. In addition, the GDPR, the EU Data Protection Act, as well as the MDR and the IVDR were discussed as relevant regulatory frameworks.

In the practical session, Dr Hunke used concrete case studies and interactive exercises to illustrate how risk assessments can be carried out in a structured manner and how criticality matrices can be applied consistently to avoid compliance gaps and costly corrective measures.

A key focus was on the topic of supplier assessment: participants learnt which questions need to be asked when selecting cloud-based AI tools with regard to data protection, certifications, data storage location and contractual safeguards.

In the concluding presentation on governance and secure use, Dr Hunke presented an AI governance framework based on four pillars, encompassing policies and guidelines, processes and workflows, roles and responsibilities, and technical monitoring systems.
The training session concluded with an open discussion in which participants were able to share their own challenges from business practice and work together to develop possible solutions.

 
Are you also looking for a customised training solution for your employees or team? We offer the right solution, either on-site at your location or as an online seminar.

Author: Dr Henriette Wolf-Klein

The online conference on 11 March 2026 examined current regulatory and economic developments in the biosimilars market – with a focus on Germany.

Regulatory developments regarding ‘Aut idem’

Dr Petra Nies (G-BA) presented the new Section 40c of the Medicines Directive, which comes into force on 1 April 2026 and regulates the automatic substitution of finished medicinal products by pharmacies. Pharmacies are generally obliged to dispense a lower-priced medicinal product if the following conditions are met: same strength and pack size, same or interchangeable dosage form, authorised for at least the same routes of administration as the prescribed medicinal product, and at least one identical indication. Interchangeable dosage forms must in future be described in Annex VII of the Medicines Directive. Thomas Müller (BMG) did, however, indicate that amendments to the regulations might be made, particularly with regard to discount agreements within the framework of the pharmacy reform.

Streamlining biosimilar development

Dr Elena Wolff-Holz (Biocon Biologics) provided an update on regulatory developments in Europe, the US and globally, which aim to streamline biosimilar development and, in most cases, make Phase III trials unnecessary. There was heated debate as to whether this would lead to more biosimilars across all indications or merely a wider choice of different biosimilars in the blockbuster segment. Currently, two-thirds of products due to lose patent protection in the near future lack a biosimilar in development.

Market access strategies

Tim Steimle (Techniker Krankenkasse) favours a regional multi-partner model over open-house approaches for future biosimilar tenders and advocates binding supply contracts. The Critical Medicines Act will introduce further binding tendering rules from 2027 onwards. Dr Christopher Kirsch (Sandoz) and Dr Michael Soldan (Zentiva) discussed the implications of the new Section 40c for the pharmaceutical industry and the growing importance of partnerships and in-licensing.

Practical challenges

Markus Kerckhoff (Schloss Apotheke) highlighted the high demands placed on the supply chain for biologics, which are not always met, particularly in cases of passive rather than active cooling and in the return processes.

Author: Dr Henriette Wolf-Klein

On 26 February 2026, Dr Barbara Müller-Jakic, Head of Regulatory Affairs DACH at Sanofi-Aventis Deutschland GmbH, presented in a webcast of the Online Pharma FORUM how artificial intelligence is transforming regulatory work.

Sanofi-Aventis is pursuing a three-pillar strategy comprising Expert AI for research and manufacturing, Snackable AI for data-driven prioritisation in day-to-day work, and enterprise-wide generative AI, which is currently delivering the greatest productivity gains in Regulatory Affairs.

Specific use cases include the automated creation of clinical study reports with efficiency gains of up to 65 percent, the HAQA tool for drafting responses to authority questions based on more than 100,000 historical questions and answers, field-specific prompts for EU briefing packages, and the specialised translation system OneTranslate, which has reduced translation cycle time by around 75 percent.

The internal assistant “Concierge” provides a closed language model trained on company data and equipped with agentic capabilities. Throughout, the principle of “human in the loop” applies: AI produces drafts, and humans review and approve them. The internal governance framework RAISE ensures ethical standards, data protection, and risk management.

On the regulatory side, the EU AI Act with its risk-based classification, the EMA reflection paper on the regulatory relevance of AI, and the joint EMA/FDA guiding principles provide the framework. For each AI application in a regulatory context, companies should assess three questions: Does it generate data relevant to marketing authorisation? Does it affect patient safety? Does it influence regulatory decisions? If the answer is yes, an early dialogue with the regulatory authorities is recommended.

Author: Dr Helmut Vigenschow

Navigate the latest stability testing topics related to drug products with this comprehensive overview on the regulatory requirements during product development and lifecycle. This includes aspects covered by the new draft ICH Q1 guideline. This resource clarifies regulatory expectations for marketing authorisation applications, covering essential topics like accelerated testing conditions, shelf-life determination, climatic zone requirements, and stability commitments. Understand how to design compliant studies, interpret results, and prepare CTD documentation effectively. A practical reference for pharmaceutical professionals seeking current guidance to support regulatory submissions and ensure compliance.

Download now the white paper 'Stability Testing of Drug Products – Focus: EU and ICH Requirements'.

We wish you many valuable insights as you read.

The recent online Pharma FORUM (19 November 2025) explored key topics in Regulatory Operations, including XEVMPD, SPOR, PMS, PLM-eAF and ePI.
 
Part 1: Insights into SPOR PMS with Dr Georg Neuwirther (AGES)
Dr Neuwirther provided valuable recommendations for working with the SPOR PMS guidances:

• Practical starting point: He advised participants to begin reading with Chapter 8, as it contains practical application examples.
• Central reference: Chapter 2 serves as the “bible of database elements” and is an essential reference.
• Transition phase: Although PMS will eventually replace XEVMPD, no decommissioning date for XEVMPD has been set. Therefore, maintaining both systems in parallel remains necessary.

 
Part 2: The transition to PLM eAF
In the second part of the session, Dr Neuwirther and Karl-Heinz Loebel (Cencora PharmaLex) encouraged participants to actively shape the shift towards the PLM Portal:

• Preferred submission route: Variation submissions should from now on primarily be made via the PLM Portal.
• Alternative solution: Submission via PDF form should only be used as a fallback in case of technical issues, as this option is expected to be phased out during 2026.
• Risk-free testing: It was highlighted that test eAFs can be created in the system to familiarise oneself with the new processes without risk, as these have no impact on existing authorisations.

 
Author
Dr Henriette Wolf-Klein
Department Manager Pharma & Healthcare
h.wolf-klein@forum-institut.de