News & Events

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 …

On March 21st 2024, the Nonclinical Working Party adopted the first revision of the Guideline on the environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00 Rev. 1) that will come into force as of September 1st 2024. This revision is the final result of a Concept Paper, published back in 2016.   The… View Article …

EMA released the second edition of the Product Lifecycle Management (PLM) Insights Newsletter, designed to keep pharmaceutical companies up-to-date on the latest developments in digital capabilities for PLM. This edition is now publicly available. Why Subscribe to PLM Insights? Subscribing to the PLM Insights Newsletter offers numerous benefits, including: Quarterly Updates: Receive the most… View Article …

EMA and EU Commission Strengthen Measures to Prevent and Mitigate Medicine Shortages On June 18, 2024, the European Medicines Agency (EMA) released templates for Shortage Prevention Plans (SPPs) and Shortage Mitigation Plans (SMPs). These templates are aimed at marketing authorization holders (MAHs) in the EU/EEA to help minimize the risk of medicinal shortages. This… View Article …

JAZMP released the first issue of a free electronic newsletter for healthcare professionals, which summarizes new drug safety announcements and important changes to product information. JAZMP will issue the Pharmacovigilance Bulletin quarterly and the aim is to gather all important information from the past period in one place and forward it to healthcare professionals.  … View Article …

We would like to draw your attention to the ongoing public consultation on the Variations Classification Guideline, available until August 23, 2024. The proposed amendments can be reviewed on the following webpage:: Variations guidelines: Proposed amendments to the European Commission guidelines on variations categories and procedures. The Heads of Medicines Agencies (HMA) and the European… View Article …

New version of the CTIS public portal was launched on 18th of June 2024 by EMA. Additionally, the new ACT EU – User guide provides a summary of the revised CTIS transparency rules.   The updated rules achieve a balance between information transparency and Commercially Confidential Information (CCI) protection. Patients benefit from them since important… View Article …

Research on the reprocessing of single-use devices (SUDs) in the EU was commissioned by the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) to evaluate the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices. The study, which began in December 2022 and lasted for 14 months, was carried out by… View Article …

The ICH E2D guideline has been first published in May 2003 to establish an internationally standardized procedure to improve the quality of post-approval drug safety information and to harmonise the way of gathering and reporting it. The revised version of the guideline (ICH E2D(R1)) released for public consultation provides updates on the definitions, standards, and regulatory guidance for the management …

New legislation in Great Britain is poised to update the requirements outlined in the Veterinary Medicines Regulations 2013, aiming to modernize them. The forthcoming Veterinary Medicines (Amendment etc.) Regulations 2024 (available at; The Veterinary Medicines (Amendment etc.) Regulations 2024 (legislation.gov.uk)) will ensure the UK remains an appealing hub for the development and marketing of veterinary… View Article …

Hydroxyprogesterone Caproate Medicines to be Suspended from the EU Market   EMA’s safety committee (PRAC) recommended suspending marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the EU. The PRAC review found a possible but unconfirmed risk of cancer in those exposed to 17-OHPC in the womb. The review also considered new studies, which showed… View Article …

Abolition of GMP Simplifications Effective from April 17, 2024, Ukraine has abolished the temporary simplifications regarding the validity of GMP certificates that were in place during the martial law period. This resolution mandates that all imported medicinal products must now provide a GMP compliance conclusion from the State Service of Ukraine on Medicines and Drug… View Article …

Over the past decade, supply chains within the pharmaceutical industry have become increasingly complex. This is a result of a growing outsourcing trend, combined with a supplier base that is more and more spread from a global perspective. This situation makes API manufacturers more dependent on their suppliers and more vulnerable to supplier related risks…. View Article …

The presence of nitrosamine impurities in medicinal products has raised safety concerns regarding the consumption of various pharmaceuticals. These contaminants can develop at any phase, from the initial synthesis of the drug substance through the entire lifespan of the product, especially when an amine interacts with a nitrosating agent under favourable conditions.   Addressing this… View Article …