The International Coalition of Medicines Regulatory Authorities (ICMRA) has developed a joint statement on the establishment of a pharmaceutical quality knowledge management system, which could help to better inform both public and industry stakeholders on the coalition’s efforts to improve global regulatory harmonisation and alignment.
Regulatory authorities can gain efficiencies by developing common procedures, guidelines, requirements, and interoperable infrastructure that would facilitate the timely sharing of information on changes occurring within the supply chain of medicines. This may include reliance on the assessments of other regulators but could lead to more timely availability of medicines for patients by shortening approval timelines.
PQKMS Statement
Global Pharmaceutical Quality Knowledge Management: Enhancing Regulatory Reliance and Agility [PDF]
Other languages
- Arabic - بيان التحالف الدولي حول إدارة معرفة الجودة الصيدلانية العالمية لتعزيز الاعتماد التنظيمي ومرونة التنفيذ
- French - Gestion globale des connaissances sur la qualité des produits pharmaceutiques : Améliorer la fiabilité et l’agilité de la réglementation [PDF]
- Japanese - グローバルな医薬品品質知識管理: レギュラトリー・リライアンスとアジリティの向上 [PDF]