国际药品监管机构联盟（ICMRA）、人用药品技术要求国际协调理事会（ICH）、国际药品监管者计划（IPRP）与药品检查合作计划（PIC/S）正在协同发力，建设数据基础设施，以支持形成全球监管性药品质量知识管理（PQKM）能力，最终使高质量药品更易获得。这四个组织在 2022 年 7 月发布的联合反思文件中提出了发展这一全球能力的共同愿景。该文件阐明了支持监管 PQKM 能力建设所必需的、协调一致并有多方利益相关者参与的协调工作路径。可以设想，此类工作能够加强国际合作，支持全球的研制、生产和供应，最终使公众及时获得安全、有效、高质量的药品，从而保障公众健康。
The International Coalition of Medicines Regulatory Authorities (ICMRA), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), International Pharmaceutical Regulators Programme (IPRP), and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are aligning efforts to build the data infrastructure to support a global regulatory Pharmaceutical Quality Knowledge Management (PQKM) capability to ultimately enable better availability of high-quality medicines. The shared vision of the four organisations for the development of this global capability was outlined in a Joint Reflection Paper published in July 2022. The paper outlined the coordinated, multi-stakeholder approach to harmonisation work required to support the development of a regulatory PQKM capability. It is envisaged that such work can strengthen international collaboration to support global development, manufacture, and supply, ultimately resulting in timely access to safe, effective, high-quality medicines, and thereby assuring public health.