NOTICIAS

This guidance provides FDA’s current thinking on the scope and application of 3-year exclusivity under section 505(c)(3)(E)(iii) and 505(j)(5)(F)(iii) of the FD&C Act for drug products approved with new clinical investigations (other than bioavailability studies)...

“Formação bastante esclarecedora, em que a informação foi apresentada de forma clara e bem resumida servindo de bom ponto de partida para aprofundar conhecimentos no papel da IA na indústria farmacêutica. Foram também apresentados exemplos práticos o que permitiu...

A Formiventos apresentou no passado dia 27 uma nova edição da formação : GESTÃO da DISPONIBILIDADE do MEDICAMENTO ✅Foi uma formação com uma forte componente prática, com o objetivo de alargar a experiência e o conhecimento relativo aos pontos críticos das...

The information in this document applies to all medical devices, including IVD medical devices. Unless otherwise specified, the principles discussed can be applied to any phase of the product lifecycle (e.g., technical documentation2 review, evaluation of quality...

MDRF International Medical Device Regulators Forum. Considerations for the selection of IMDRF Adverse Event Terminology A Guide for Industry Partners and Healthcare Providers. 25 February 2026 Scope: This document is intended to provide guidance on the correct...

A concept paper on the revision of Annex 15 has been published on the EMA's website. One of the main objectives of the revision is to make the application of Annex 15 mandatory for active substances (APIs). Until now, its application has been optional for active...

  The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “E22 General Considerations for Patient Preference Studies.” The draft guidance was prepared under the auspices of the International...

The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on proposals for the approach to recognising CE marked medical devices in Great Britain. We welcome the views from anyone who will be impacted by...

Health Technology Assessment: HTA Coordination Group publishes its 2025 Annual Report The Member State Coordination Group on Health Technology Assessment (HTACG) has published its 2025 Annual Report, providing an overview of the first year of application of the EU...

This guidance aims at supporting applicants in completing the 'Precise scope and Background for a change, and Justification for grouping, worksharing and classification for unforeseen changes (if applicable)' (hereinafter called the 'Precise scope') section of the...

The 4th edition of the Guide to Quality in Analytical Chemistry, has been published by Eurachem on 6 February 2026. This widely used guide provides laboratories with practical best-practice guidance for analytical operations, covering both qualitative and quantitative...

The ICH M15 Guideline, General Principles for Model-informed Drug Development, has been adopted (Step 4 of the ICH harmonisation process) and will now enter the implementation phase (Step 5).  Prior to the development of the M15 Guideline, a lack of common standards...

  FDA is issuing this guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality management system. This guidance: · Describes “computer software...

The FDA’s Center for Drug Evaluation and Research (CDER) has released its 15th annual New Drug Therapy Approvals report, offering a useful snapshot of the pace and direction of drug development in 2025. In 2025, CDER approved 46 new drugs never before approved or...

Medical device/medtech regulatory updates this week: The MDSAP Audit Approach (MDSAP AU P0002.010) A few suggested next steps if you're impacted here: 1/ Audit your audit program. Your internal audit procedures and checklists likely reference QSR language and clause...

  This document supersedes “Clinical Decision Support Software” issued on January 6, 2026.   The Food and Drug Administration (FDA) has long regulated software that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic...

The U.S. Food and Drug Administration (FDA) has published “Cybersecurity in Medical Devices: Quality Management System (QMS) Considerations and Content of Premarket Submissions” updated guidance issued 3 February 2026. This guidance replaces the 2025 edition and...

The FDA's updated compliance program manual page: https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/center-devices-and-radiological-health-cdrh-compliance-programs

Feb 02, 2026 marks the end of the 2‑year transition and the beginning of a globally aligned quality era, harmonized with ISO 13485:2016 👉 As of TODAY, all FDA-regulated companies must comply. If you manufacture, design, or distribute FDA-regulated medical...

EMA Releases ICH M11: A New Era for Clinical Study Protocols The EMA has published the ICH M11 guideline, introducing a harmonised, structured and digital-ready template for clinical study protocols — a major step forward for global clinical research. 🔹...

These guidelines provide an overview of the key considerations of the Committee of Experts on the Classification of Medicines as Regards their Supply (CD-P-PH/PHO), co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council...

📅 Adopted: 28 January 2026 📰 Published in the OJEU: 30 January 2026 Amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for neurosurgical implants, biological evaluation of medical devices, clinical investigation of medical...

  Tendo em conta a alta prevalência de “inconformidades nos dossiers de AIM” nos mais diferentes procedimentos quando são submetidos, que leva naturalmente a problemas nos tempos de aprovação, a Formiventos apresentou no passado dia 28 uma nova edição da formação...

This guide was drafted by a multidisciplinary working group under the overall co-ordination of the Committee of Experts on Quality and Safety Standards in Pharmaceutical Practices and Pharmaceutical Care (CD-P-PH/PC). It provides: ✅ Structured recommendations...

ICH HARMONISED GUIDELINE: The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality SCOPE AND ORGANISATION The M4Q(R2) guideline establishes the location and structure of quality information for registration applications of all...

Release notes: https://lnkd.in/dmRB2inn User Manuals. Legacy devices: https://lnkd.in/d5cjaMgz Regulation devices: https://lnkd.in/dGSwt9rp

EU & US Regulatory News (AI in Drug Development – Guiding Principles) The European Medicines Agency (EMA), in collaboration with the U.S. Food and Drug Administration (FDA, has published Guiding Principles of Good AI Practice in Drug Development (January 2026)....

The ICH Expert Working Group (EWG) has released additional training materials to support the implementation of ICH E6(R3), with a specific focus on Module 4: Informed Consent. Two transcripts are now available: 🔹 Module 4.1 (5 pages) Addresses key questions...

EMA have just published the overview of the 2025 EMA’s key recommendations in human medicines. It includes figures on the authorisation of medicines and a selection of new treatments that represent significant progress in their therapeutic areas. ✔️ 104...

EMA and the FDA have jointly identified 10 principles for good artificial intelligence practice in the medicines lifecycle. The use of AI technologies across the medicines lifecycle has increased significantly in recent years and holds great promise as a tool to...

The European Pharmacopoeia (Ph. Eur.) has published  a new general chapter on Quality of data (5.38) in Issue 12.3, following its adoption by the European Pharmacopoeia Commission at its 182nd session in June 2025. New general chapter on quality of data 5.38 supports...

This guidance further clarifies that FDA’s existing digital health policies continue to apply to software functions that meet the definition of a device, including those that are intended for use by patients or caregivers. This guidance provides many examples of how...

This document provides guidance to sponsors and applicants submitting investigational new drug  applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or  supplemental applications on the appropriate use of Bayesian methods in...

In this policy brief, team members from Science-Metrix, NIFU and UNU-MERIT (Maastricht University) first conducted a literature review of the current debate on the use of GenAI in research, specifically on the use of chatbots (Section 2). The review is organised...

The Food and Drug Administration (FDA) is issuing this guidance document to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health’s (CDRH’s) compliance policy for low risk products that promote a healthy lifestyle (general...

IMDRF is committed to sustaining its strong global leadership while continuing to meet  the needs of and engage with its growing number of members and stakeholders. In recent years, IMDRF has led globally in expanding its offerings, now conducting training and...

EMA has published its updated “Classification of changes” guidance (Nov 2025) the procedural framework for classifying and submitting variations to marketing authorisations for medicinal products in the European Union. This guidance governs how companies should manage...

The Medical Device Coordination Group  has published MDCG 2025-9 – Guidance on Breakthrough Devices (BtX) under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR). This guidance introduces a structured EU framework to support the development, conformity assessment,...

  The Medical Device Coordination Group (MDCG) has released MDCG 2025-10 – Guidance on Post-Market Surveillance (PMS) of Medical Devices and In Vitro Diagnostic Medical Devices (Dec 2025). This document supports manufacturers in understanding and implementing...

Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation...

Why is the Commission proposing a targeted simplification of the Medical Devices Regulations? Medical Devices and in vitro diagnostic medical devices range from sticking plasters, influenza and pregnancy tests to advanced imaging equipment, implants such as hip...

The European Commission has published a proposal to amend MDR (EU 2017/745) and IVDR (EU 2017/746), introducing substantial regulatory changes aimed at simplifying compliance, improving predictability, and safeguarding device availability in the EU. The proposal aims...

Just published - the most influential guideline for the modern pharmacovigilance today.   This report on Artificial intelligence in pharmacovigilance addresses a rapidly emerging cross-disciplinary field that is at the intersection of pharmacovigilance, computer...

The European Pharmacopoeia (Ph. Eur.) has continued to build upon its work in the field of therapeutic monoclonal antibodies with the publication of its first monoclonal antibody (mAb) medicinal product monograph, for the IgG1-antibody based TNF-alpha...

A partir de 15 de janeiro de 2026, aplicar-se-á a nova versão das Orientações sobre os pormenores das diversas categorias de alteração relativas a alterações dos termos das autorizações de introdução no mercado  

EUDAMED user guide UDI Devices Release 3.022 Dec 12 2025

Regulatory housekeeping with strategic implications: the FDA just updated 179 sections across 21 CFR to reflect the QMSR shift. The FDA has published a new final rule updating references across 21 CFR Parts 801, 803, 812, 860, 862, 864, 866, 868, 872, 874, 876, 878,...

We welcome the political agreement reached on the pharma reform last night, which is a crucial step in boosting innovation and investment in the EU’s pharma sector. The main aim of the new rules is to make sure that medicines in the EU are safe, effective and...

Artificial  Intelligence is rapidly reshaping the pharmaceutical landscape, from discovery and development to manufacturing and post-approval safety monitoring. As AI becomes more deeply embedded in regulatory decision-making and in processes that directly impact...

the Committee of Experts on Quality and Safety Standards in Pharmaceutical Practices and Pharmaceutical Care (CD-P-PH/PC), from European Directorate for the Quality of Medicines & HealthCare free practical guide for healthcare professionals ✅ Structured...

Document issued December 3, 2025.   To comply with the GGP regulations ensuring that regulated entities and the public understand guidance documents as nonbinding, FDA guidance documents ordinarily contain standard language explaining the content to be viewed...