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.
Ensuring 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 harmonization 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 and promoting increased reliance among Regulators as well as mutual recognition agreements
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. We also strongly support increased information-sharing among well - and moderately well- resourced regulatory authorities, which, together with convergence and harmonization, will support work-sharing and regulatory reliance on evaluations and decisions, the ultimate goal being increased mutual recognition agreements.
Preventing 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.
Preventing 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