GBMA is an associate member of the International Generic and Biosimilar Medicines Association (IGBA)
The International Generic Pharmaceutical Alliance (IGPA) was founded in March 1997 as an international network of generic medicines associations. To reflect the evolving nature of the industry, in September 2015, IGPA incorporated under Swiss Law, and at the same time changed the name of the organization to the International Generic and Biosimilar Medicines Association (IGBA).
In 2016, IGBA was admitted as an ICH Assembly Member and in 2018 as an ICH Management Committee Member.
Since September 2019, IGBA has been an Accredited WIPO Observer and in January 2022 IGBA got admitted as non-State actor in official relations with WHO, which underscores the importance of generic and biosimilar medicines in increasing worldwide patient access to safe, effective and high-quality affordable medicines.
IGBA is committed to promoting generic and biosimilar medicines, and exchanging information worldwide.
IGBA consists of the following associations:
- Association for Accessible Medicines (AAM- United States)
- Canadian Generic Pharmaceutical Association (CGPA-Canada)
- Generic & Biosimilar Medicines Southern Africa (GBMSA-South Africa)
- Indian Pharmaceutical Alliance (IPA – India)
- Jordanian Association of Pharmaceutical Manufacturers (JAPM-Jordan)
- Japan Generic Medicines Association (JGA-Japan)
- Medicines for Europe (Europe)
- Taiwan Generic Pharmaceutical Association (TGPA-Taiwan)
- In addition, the generic and biosimilar medicines associations of Australia, Argentina, Brazil, Malaysia, Mexico, Republic of Serbia and Republic of Montenegro are Associate Members
Through its constituent member associations, the IGBA maintains constant dialogue with the ICH, WHO, WTO, WIPO and other international organizations.
IGBA members share a set of common principles:
Access to high-quality cost-effective medicines
- We believe that seeking to improve access to high-quality, cost-effective medicines worldwide and promote the quality, safety and efficacy of generic and biosimilar medicines is of utmost importance for global public health.
Ensure timely access for patients
- We promote balanced intellectual property rights and their enforcement which safeguards fair competition, thereby ensuring timely access for patients to generic and biosimilar medicines.
Global convergence and harmonisation of regulations relating to quality
- A top priority remains promoting global convergence leading to harmonization of regulations relating to the quality of generic and biosimilar pharmaceutical products, especially ensuring strict adherence respectively to bioequivalence standards and comprehensive comparability studies, including a path for more tailored clinical biosimilar development.
Improving regulatory and legal expertise
- We continue to provide guidance to international organizations and national governments to improve their regulatory and legal expertise relating to the manufacture, registration and marketing of high-quality generic and biosimilar medicines, and promotion of uniform and effective GMP standards and quality controls.
Prevent and/or mitigating medicines shortages
- We continuously address the international collaboration on medicines shortages by fostering cooperation across the pharmaceutical supply chain to help prevent and/or mitigate medicines shortages. We continue to encourage a patient-centric, proactive dialogue to address the root causes of medicine shortages and improve mitigation efforts. This dialogue should involve all stakeholders: patients, payers, healthcare professionals, regulators and supply chain participants to achieve the most benefit.
Prevent the production and trade of counterfeit versions
- We are also advocating for strict, uniform and effective regulatory controls to prevent the production and trade of counterfeit versions of all medicines and their active pharmaceutical ingredients