Print

Global regulators and biopharmaceutical and vaccine industry to share experiences with managing pharmaceutical quality systems (July 2023)

On 20 July 2023, the International Coalition of Medicines Regulatory Authorities (ICMRA) is hosting a virtual workshop on the development of a global Pharmaceutical Quality Knowledge Management System (PQ KMS), which aims to facilitate the exchange of knowledge related to pharmaceutical quality amongst national regulatory authorities worldwide.

Print

IGBA Welcomes ICH New Topic for Harmonisation: “Bioequivalence for Modified-Release Products” (June 2023)

The International Generic and Biosimilar Medicines Association (IGBA) commends the General Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for its adoption of a new topic focused on the harmonisation of "Bioequivalence for Modified-Release Products." This significant development, which took place at the recent ICH meeting in Vancouver, Canada, marks the introduction of a new ICH Multidisciplinary Guideline, which aims to further strengthen consensus and harmonisation among ICH members regarding bioequivalence standards for more complex dosage forms. These efforts build upon the existing harmonisation initiatives found within the upcoming M13 series of bioequivalence guidelines.

Print

IGBA CEO Advisory Committee Vienna Statement - Four Keys to More Predictable Supply Chains (June 2023)

Vienna, June 14, 2023 - The COVID-19 pandemic demonstrated the critical importance of resilient global supply chains. As the CEO Advisory Committee of the International Generic and Biosimilar Medicines Association (IGBA), we underscore the essential role of the off-patent pharmaceutical sector in ensuring that patients worldwide have equitable access to quality-assured, and affordable medicines.

Share this page!

Contact Info

IGBA | INTERNATIONAL GENERIC AND BIOSIMILAR MEDICINES ASSOCIATION

C/O DYN SA
Rue de Cornavin 11
1201 Geneva, Switzerland

E-mail: 
This email address is being protected from spambots. You need JavaScript enabled to view it.  

Follow us on: Twitter - LinkedIn - YouTube

We use cookies to improve our website and your experience when using it. Cookies used for the essential operation of the site have already been set. To find out more about the cookies we use and how to delete them, see our Privacy Policy.

I accept cookies from this site