News & Events

As of the 1st of January, a new version of the Human Variation eAF form is available and should be used for all human variation applications. The changes are the result of updates to Variation Regulation and can be found here: Guidance on the application of the amended Variations Regulation from 1 January 2025 | European… View Article …

As we step into 2025, Billev Pharma East looks back with pride at the achievements of 2024 and moves forward with fresh optimism for the year ahead. In a constantly evolving pharmaceutical landscape, our unwavering dedication to excellence, innovation, and reliability remains our guiding principle. Throughout last year, we faced challenges head-on and embraced new… View Article …

The EU’s Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) were designed to enhance patient safety and device quality.  However, by 2024, systemic challenges had reached a breaking point, leading to urgent calls for reforms to ensure the regulations achieve their intended goals without compromising the industry’s ability to innovate. The European Parliament’s… View Article …

The European Medicines Agency (EMA) has updated its EU GMP/GDP FAQ under EU GMP Guide Annexes: Supplementary Requirements:Annex 16.This update aims to clarify documentation standards to ensure the traceability of the supply chain for active substances and medicinal products, supporting Qualified Persons (QPs) in batch certification and release. Key Recommendations:•   Maintain timely and adequate supply… View Article …

We are delighted to share that Ajla Mušić, M.Sc.Pharm, Pharmacovigilance Officer at Billev Pharma East Ltd., held a highly informative webinar on December 2nd titled “Ensuring Safety and Compliance – From Technical Documentation to Clinical Evaluation”.  This engaging session was designed to guide participants in navigating the complexities of preparing technical documentation and clinical evaluations… View Article …

The European Union is set to implement its new Health Technology Assessment Regulation (HTAR, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2282) on January 12, 2025, marking a significant shift in the evaluation and market access processes for medicinal products. The HTAR introduces a streamlined, EU-wide framework for assessing the clinical value of these health technologies, replacing the patchwork of national processes… View Article …

In November 2024, the Medical Device Coordination Group (MDCG) published a Q&A document Gradual roll out of EUDAMED. This document addresses practical issues related to the phased implementation of EUDAMED under the MDR and IVDR. It covers the gradual introduction of EUDAMED, the requirement to notify authorities about supply interruptions or discontinuations, and the transitional… View Article …

The Medical Device Coordination Group (MDCG) is a regulatory body established by the European Union to help ensure that the Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices are consistently and effectively applied across all EU member states. Here’s a closer look at the MDCG’s… View Article …

In 2024, the Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) launched a new, free electronic bulletin aimed at informing healthcare professionals about current drug safety topics and important updates in drug information. The bulletin, published up to four times a year, consolidates key notices and updates in one place, providing easy access to… View Article …

Billev Pharma East Ltd. proudly participated in the 2024 TOPRA Symposium, held from September 30 to October 2 in Rotterdam, the Netherlands. This prestigious event, co-organized with the Medicines Evaluation Board (MEB), the Netherlands’ national authority for medicines and health products, is widely regarded as Europe’s premier conference for regulatory affairs in healthcare. The annual… View Article …

Don’t miss this opportunity to learn from our regulatory expert Suzana Šalinger in an insightful course on Veterinary Marketing Authorisation Variation in the EU. Billev is pleased to invite you to participate in this comprehensive course, organised by Life Science Academy, where Suzana will provide an overview of the latest regulations governing veterinary medicinal products…. View Article …

EMA has recently released an updated version of its Q&A document regarding combination products, which include both medicinal products and medical devices. The regulation of these products poses unique challenges, as they must adhere to the requirements of both medicinal product regulations (such as Good Manufacturing Practices, GMP) and medical device regulations (like ISO 13485)…. View Article …

The FDA has updated its guidelines to assist pharmaceutical manufacturers in addressing the risks associated with nitrosamine impurities.   In September 2024, the FDA released its updated guidance, replacing the February 2021 version. The new guidelines outline crucial steps for manufacturers to detect, manage, and prevent the presence of nitrosamine impurities in both active pharmaceutical ingredients… View Article …

As part of the Windsor Framework agreement, important changes to pharmacovigilance for medicines authorized in the UK will take effect on 1 January 2025. These changes are designed to streamline and enhance the regulation of medicines across the UK. Key Changes Effective from 1 January 2025: 1. UK-Wide Licensing by MHRA:    – Starting from 2025,… View Article …

Antimicrobial resistance (AMR) has been a long-standing issue in human healthcare and is now increasingly recognized as a significant concern in animal health. Addressing the growing threat of AMR, particularly antibiotic resistance, is a top priority for the European Medicines Agency (EMA) and the broader European medicines regulatory network. In veterinary medicine, there is an… View Article …

PRAC elects new chair The July 2024 meeting of EMA’s safety committee (PRAC) was the last plenary meeting chaired by Sabine Straus, who retires as Chair after serving for two three-year mandates. The Committee elected Ulla Wändel Liminga from Sweden as its new Chair. New recommendations for GLP-1 receptor agonists to minimise risk of aspiration… View Article …