The company continues to strengthen professional development standards with training on updated ICH and EMA regulations
GM PHARMA, a leading international pharmaceutical company and a regional pioneer in innovation and modern pharmaceutical technologies, continues to invest actively in research and development.
The company consistently integrates state-of-the-art technologies and the latest manufacturing methodologies, enabling the creation and enhancement of products that best meet the evolving demands of modern medicine.
Currently, GM PHARMA’s Research and Development (R&D) Department is working on 18 new medicines aimed at improving the efficacy and safety of treatments across multiple therapeutic areas. In addition, more than 30 new products are planned to be introduced, significantly expanding GM PHARMA’s portfolio and strengthening its ability to effectively address medical challenges.
By investing in innovation and maintaining a strong focus on regulatory compliance, GM PHARMA continues to move confidently toward achieving EU GMP certification, reinforcing its long-term commitment to excellence, quality and patient well-being.
GM PHARMA was once again visited by the German expert Dr. Helmut Vigenschow.
A four-day training program and a series of practical workshops were conducted for the company’s Research & Development (R&D), Regulatory Affairs and Quality Assurance departments. The purpose of the training was to update the team’s knowledge in line with new international guidelines and recent changes in global regulatory frameworks.
Dr. Vigenschow is the Founder and Senior Consultant of ViPharmaService and an active member of several leading professional organizations, including the European Generic Medicines Association (EGA) and the German Medicines Manufacturers’ Association (BAH), among other scientific committees.
The main topic of the training - “New ICH and EMA Guidelines” - focused on the latest guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the European Medicines Agency (EMA).
The ICH establishes internationally agreed guidelines that serve as unified standards for the development, quality, safety and efficacy assessment of medicinal products.
The purpose of these guidelines is to harmonize pharmaceutical regulations among the world’s leading regions (including Europe, the United States, Japan and other countries) ensuring consistency and alignment in global pharmaceutical practices.
As Dr. Helmut Vigenschow notes - “The European Union’s regulatory framework is in a phase of substantial reform, creating complex challenges for stakeholders across the pharmaceutical industry. Over the past twelve months, the number of guidelines adopted and published by ICH and EMA has increased substantially compared to previous years. These documents have a direct impact on GM PHARMA’s activities in research and development, quality assurance and regulatory affairs.Based on these updates, the training once again demonstrates GM PHARMA’s strong commitment to continuous development and full compliance with international standards. With its entry into the EU market, the company aims to uphold and further advance the culture of producing high-quality, safe and effective pharmaceutical products.”
The training represents a long-term investment, as it helps reduce risks associated with drug registration processes, enhances the quality of scientific work and reflects the company’s professionalism at an international level. This initiative marks another important step forward and serves as a prerequisite for entering the EU market. It is also worth noting that the company has already submitted its application for EU GMP certification.
As the only international multinational pharmaceutical company originating from Georgia, GM PHARMA aims to expand its business within the European Union market. The company continues active preparation for obtaining EU Good Manufacturing Practice (EU GMP) certification - a milestone that represents not only a crucial stage in GM PHARMA’s own growth and development, but also a significant contribution to the evolution of Georgia’s pharmaceutical industry.