Regulatory Affairs & Life Science

The new EU Packaging and Packaging Waste Regulation (PPWR) 2025/40 has introduced stringent rules across the entire supply chain. But what does it mean in practice for highly regulated industries?

In this episode, we break down the impact of the PPWR on:

• Pharmaceuticals (human & veterinary) and primary packaging exemptions
• Medical Devices & IVDs: eco-design, UDI labeling, and secondary packaging
• Food Supplements & Cosmetics: recyclability, labeling, and volume reduction
• Foods for Specific Groups (FSG & FSMP)

We also discuss the key roles of Manufacturer vs. Producer (EPR), technical documentation, and critical deadlines to ensure regulatory compliance.
Read the full article on the Di Renzo Regulatory Affairs blog:
https://en.direnzo.biz/ppwr-packaging-regulation/

In the regulatory landscape of medical devices in Europe, Spain is introducing significant updates. In this episode, we clarify the transition that led to the decommissioning of the old CCPS database and the introduction of the new RECOPS portal (Registro de comercialización de productos sanitarios) by AEMPS.

We will analyze what changes for manufacturers and economic operators, the fundamental link with the European database EUDAMED (specifically module 2), and the timelines and obligations to comply with for marketing MDs and IVDs in Spanish territory. We will also discuss notification procedures, exemptions for custom-made devices, and how to manage ministerial fees, updates, and maintenance costs.

A must-listen episode for pharmaceutical and regulatory affairs professionals, as well as companies operating or planning to expand their market in Spain.

https://en.direnzo.biz/recops-spain/

Generative Artificial Intelligence is transforming the way pharmaceutical companies create content and scientific information. But how can technological innovation be reconciled with the current regulatory framework?In this new podcast episode, we analyze the recent AIFA Guidelines published by the Drug Information and Advertising Vigilance Unit.What we cover in this episode:

• Responsibility remains unchanged: Why the use of AI does not alter the nature of promotional material nor the obligations of the Marketing Authorization Holder (MAH) and the Scientific Service Responsible Person (RSS).
• Certified sources and verifiability: The requirement to rely strictly on official sources (such as the SmPC) and to rigorously verify outputs to prevent hallucinations or incorrect citations.
• The Human-in-the-Loop principle: The central role of human oversight at every stage of the process and the requirements within the Quality Management System.
• Chatbots and Virtual Assistants: Information obligations toward healthcare professionals, transparency, and specific disclaimers for direct-interaction tools.
• Traceability in AIFA submissions: New mandatory information for the submission sheet and the required validation declaration from the Scientific Service Responsible Person.

Visit the original article on Di Renzo Regulatory Affairs to explore all the regulatory details.

The European Chemicals Agency (ECHA) has released a new draft guidance dedicated entirely to the identification and assessment of Substances of Concern (SoC) in biocidal products under the Biocidal Products Regulation (BPR - Regulation EU No 528/2012).In this episode, we break down this major regulatory update and what it means for the chemical and manufacturing industries.

A few years after the entry into force of Regulation (EU) 2017/745 (MDR), the European Commission is taking action to make the system more sustainable. With the amendment proposal COM(2025)1023, Europe aims to cut red tape and boost the competitiveness of the medical sector—without compromising the strict safety standards of medical devices.In this podcast episode, we analyze the impact of this upcoming revision on manufacturers and industry operators.What we discuss in this episode:

• Process Digitalization: How the transition to electronic documentation and digital workflows (linked to EUDAMED) will reduce the paperwork burden.
• Flexibility for the PRRC: New opportunities for regulatory outsourcing—a breath of fresh air, especially for SMEs.
• Streamlining vs. Safety: What is changing on the administrative front and why clinical evaluation and post-market surveillance requirements remain as strict and unchanged as ever.
• Ongoing Challenges: The limited capacity of Notified Bodies and the structural bottlenecks that have yet to be resolved.

🎧 Tune in to find out how to guide your business through this regulatory evolution!📌 To delve deeper into the topic, read our full blog post: Revision of Regulation (EU) 2017/745 (MDR): Impact on Manufacturers

A distanza di qualche anno dall'entrata in vigore del Regolamento UE 2017/745 (MDR), la Commissione Europea corre ai ripari per rendere il sistema più sostenibile. Con la proposta di modifica COM(2025)1023, l'Europa punta a ridurre la burocrazia e a migliorare la competitività del settore medicale, senza però intaccare i rigorosi standard di sicurezza dei dispositivi.In questo episodio del podcast analizziamo l'impatto di questa imminente revisione sui fabbricanti e sugli operatori del settore.Di cosa parleremo in questa puntata:

• Digitalizzazione dei processi: come l'uso di documentazione elettronica e flussi digitali (legati a EUDAMED) ridurrà il carico cartaceo.
• Flessibilità per la PRRN: le nuove opportunità di outsourcing regolatorio, una boccata d'ossigeno soprattutto per le PMI.
• Semplificazione vs Sicurezza: cosa cambia sul fronte burocratico e perché i requisiti su valutazione clinica e sorveglianza post-market restano severi e invariati.
• Le sfide aperte: la disponibilità degli Organismi Notificati e i nodi strutturali ancora da sciogliere.

🎧 Ascolta la puntata per scoprire come guidare la tua azienda attraverso questa evoluzione regolatoria!📌 Per approfondire l'argomento, leggi l'articolo completo sul nostro blog: Revisione Regolamento UE 2017/745: Impatto per i Fabbricanti

As deadlines approach and new European obligations take effect, the proper management of medical devices requires unprecedented attention. In this episode, we clear up everything you need to know to successfully navigate EUDAMED registration (registrazione eudamed) without running into compliance roadblocks.We will break down the system's operational phases, explaining how to structure your data and correctly assign the UDI code (codice udi)—from the Basic UDI-DI all the way down to individual commercial packaging—to ensure full traceability and compliance with MDR and IVDR regulations. Whether you are a manufacturer, authorized representative, or importer, discover practical tips and essential steps to optimize your company's workflow and avoid bureaucratic delays.Happy listening!Listen to the episode and leave a comment with your regulatory questions.

When does a distributor or importer become, for all legal purposes, the MANUFACTURER of a medical device?
In this episode, we shed light on one of the most complex, sensitive, and controversial aspects of the European Regulation on Medical Devices (MDR 2017/745) and the European Regulation on In Vitro Diagnostics (IVDR 2017/746): Article 16.
If you work in logistics, distribution, import, or compliance in the MedTech sector, you can't miss this episode.

Let's analyze together:

👉 The 3 key scenarios in which the automatic change of legal role is triggered.
👉 The key exceptions (when label translation and repackaging do not alter your qualifications).
👉 The strict additional obligations for those who repackage (28-day advance notification and Quality Management System Certification).

Avoiding sanctions or customs blockades on the market requires a thorough understanding of your economic roles. Listen to the episode to find out how to protect your business!

Enjoy!

What happens before a drug reaches our hands or those of our animals? In this episode, we explore the beating heart of safety and compliance: GMP (Good Manufacturing Practice) audits in the pharmaceutical industry.
Together with industry professionals, we analyze why these inspections aren't just bureaucratic procedures, but rather true safeguards for public health and business stability. We'll discover the concrete benefits for companies (and marketing authorization holders), what auditors really look for when they enter a manufacturing facility, and why—after the pandemic—on-site inspections have once again become an indispensable requirement compared to remote digital controls.
If you work in the regulatory or quality sectors, or simply want to understand the rigorous standards behind the production of a human or veterinary medicinal product, this is the episode for you!

Managing shortages is more than just a logistical challenge; it is a complex web of regulatory obligations. In this episode, we analyze the latest AIFA (Italian Medicines Agency) provisions and the specific responsibilities of Marketing Authorization Holders (MAH).In this episode, we dive into:

• Mandatory communication timelines and procedures.
• Penalties for failure to notify.
• Operational strategies to prevent disruptions in patient care.

Essential listening for Regulatory Affairs and Quality Assurance professionals.
🎧 Listen to the episode now to stay compliant and informed!