News & Events

Billev Pharma East is proud to announce a significant milestone in our journey of excellence—we have officially obtained the ISO 13485:2016 certification. This achievement marks us as the first Slovenian consultancy company to be awarded this certification, further solidifying our position as a leader in regulatory affairs and quality management services for medical devices. The… View Article …

We are proud to share that Billev Pharma East recently participated in the 27th GMP PharmaCongress & GMP PharmaTechnica Expo 2025, held on April 8–9, 2025, at the RheinMain CongressCenter in Wiesbaden, Germany. Attending as a delegate, our colleague Špela Perčič had the opportunity to engage with industry experts, gain valuable insights, and stay updated… View Article …

The European Medicines Agency (EMA) has set up the European Medicines Shortage Monitoring Platform (ESMP) with the aim of improving the exchange of information and preventing, identifying and managing shortages across the EU/EEA.The platform aims to ensure the continued availability of medicines during public health crises and major events. Based on data entry from national… View Article …

In March 2025, the leading European medical technology industry, represented by MedTech Europe, AESGP, COCIR, EEAR, EUROM, and FIDE, issued a joint discussion paper advocating for a reform of the European regulatory system for medical devices (MDs) and in vitro diagnostic medical devices (IVDs). This paper highlights the need for a more efficient, transparent, predictable,… View Article …

On 5 March 2025, the European Health Data Space (EHDS) Regulation was officially published in the Official Journal of the European Union. The regulation enters into force on 26 March 2025, marking the start of a structured transition towards its full implementation. Key Implementation Milestones Built on key existing EU frameworks, including the GDPR, Data… View Article …

The RAC25 Conference in Amsterdam was an excellent opportunity for us to deepen our knowledge, network with experts, and stay on top of the latest trends in regulatory affairs and compliance within the generic pharmaceutical industry. The event offered a wide range of topics, addressing both current challenges and upcoming changes in the regulatory environment,… View Article …

Pharmacovigilance departments must keep track of all news related to a particular medicine.  PRAC* recommendations on safety signals are one of the most important sources.  Usually, people responsible for pharmacovigilance keep a long list of websites they track, to ensure they are on top of the latest news. One of the most important is the… View Article …

February 27, 2025 marks the first day of the 23rd Regulatory Affairs Conference in Amsterdam, organised by Medicines for Europe, and our Billev Pharma East team is already actively participating in the workshops of the two-day event. Katja Pečjak Reven and Aljaž Grlica will be attending key sessions where they will be engaging with regulatory… View Article …

We’re excited that the Billev Pharma East team will be attending the 23rd Regulatory Affairs Conference in Amsterdam on February 27–28, 2025! As the regulatory industry reaches a turning point, staying ahead is no longer an option—it’s a necessity. With the ongoing revision of pharmaceutical legislation, changes in the Variations Regulation, advancements in digitalization, environmental… View Article …

In January 2025, the U.S. FDA issued draft guidance to help the pharmaceutical industry comply with 21 CFR 211.110, which outlines Current Good Manufacturing Practice (CGMP) requirements focused on the sampling and testing of in-process materials and drug products. To ensure batch uniformity and drug product integrity, CGMP regulations require that manufacturing processes are designed… View Article …

Effective January 25, 2025, the ICH Guideline M13A introduces a globally harmonized framework for bioequivalence (BE) of immediate-release (IR) solid oral dosage forms. This new standard aligns regulatory expectations across major markets and complements existing guidelines like the EMA’s “Guideline on the Investigation of Bioequivalence” (CPMP/EWP/QWP/1401/98 Rev. 1). Key Highlights of ICH M13A:– Study Design:… View Article …

In January 2025, the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) released the 3rd version of its electronic bulletin. With the introduction of the Pharmacovigilance Bulletin, JAZMP aims to ensure that updates on current drug safety topics, important drug-related information, and significant new developments are readily available in a… View Article …

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 …