早在2004年，当时从药品评价与研究中心（CDER）主任升任FDA副局长和首席医学官的Janet Woodcock医学博士就勾勒出FDA的愿景：“一个灵活、敏捷的制药制造业，能够可靠地生产高质量的药品，而无需过多的监管。”（“A flexible, agile pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive regulatory oversight.”）

二十年来，Woodcock对药品质量的关注一以贯之。2024年5月，上百位来自学术界、监管机构和行业的领导者齐聚一堂，制定了一份《质量业务领导力宣言》（Quality Business Leadership Manifesto），当时刚从FDA首席副局长职位上退休的Woodcock也是联署人之一。

在FDA发文重申质量管理的经济价值（见今日识林资讯头条）之际，识林将这份宣言翻译给会员和读者。Woodcock的愿景与FDA的文件系出同源，即药品质量管理绝非被动的日常“救火”和时不时“迎检”，其本该是药企业务增长的战略基石，并能够为企业和社会带来巨大的经济价值。但要想实现这一点，这需要药企管理层、质量人、监管方、乃至市场支付端的共同努力。

Quality Business Leadership Manifesto

《质量业务领导力宣言》

Reimagining Quality Management in Pharma: A Call to Action

重构制药质量管理：行动号召

The pharmaceutical landscape is constantly evolving with medical breakthroughs and technological advancements. Yet, our quality management systems often struggle to keep pace, particularly in the face of concerning global medicines shortages.

制药行业的格局随着医学突破和技术进步而不断演变。然而，我们的质量管理体系往往难以跟上步伐，尤其是在全球药品短缺问题令人担忧的情况下。

Beyond Compliance: A New Definition of Success

超越合规：重新定义何为成功

Simply meeting cGMP regulations is no longer sufficient. We envision a future where quality management transcends regulatory requirements, becoming a strategic cornerstone for business growth.

仅仅满足现行药品生产质量管理规范（cGMP）法规已不再足够。我们的未来愿景是，质量管理超越法规要求，成为业务增长的战略基石。

Introducing the Quality Business Leader

引入质量业务领导者

This vision demands a new kind of leader: the Quality Business Leader. These leaders possess a deep understanding of both quality and financial principles, championing:

这一愿景需要一种新型的领导者：质量业务领导者。这些领导者深刻理解质量和财务原则，他/她们倡导：

Patient-Centric Focus

以患者为中心

Every decision prioritizes patient safety and well-being. Rigorous benefit-risk analysis ensures patients have consistent access to safe, high-quality medications.

每个决策都优先考虑患者的安全和福祉。严格的获益-风险分析确保患者能够持续获得安全、高质量的药品。

Leadership by Ownership and Partnership

通过主人翁精神和伙伴关系来领导

Quality becomes a shared mindset, nurtured at all levels across the organization. Leaders foster collaboration and a sense of ownership for quality excellence.

质量成为一种共享的思维模式，在组织的各个层面得到培育。领导者促进合作，并培养对质量卓越的主人翁意识。

Regulatory Collaboration

监管合作

We advocate and lead the path to a streamlined, global regulatory framework that encourages continuous improvement and innovation, including the implementation of new ideas and technologies.

我们倡导并引领通往简化的全球性监管框架的道路，该框架鼓励持续改进和创新，包括新想法和新技术的实施。

Streamlining for Efficiency

增效

Quality management systems and processes are simplified for enhanced effectiveness, agility, and full integration into the overall company business. Every step in the supply chain is optimized for the highest quality outcomes.

简化质量管理体系和流程，以增强其有效性、敏捷性，并全面融入公司业务。供应链的每一步都经过优化，以实现最高质量成果。

Financial Advantage Through Quality

通过质量实现财务优势

We achieve sustainable financial success while upholding the highest quality standards. Quality management becomes a value that drives business prosperity.

我们在保持最高质量标准的同时实现可持续的财务成功。质量管理的价值将驱动业务繁荣。

A Call to Action

行动号召

We are driven to disrupt the current state and forge a new path. The time for action is now! Achieving this vision demands changes to how we operate and an unwavering commitment from everyone involved. Remember, every revolution begins as a vision, an idea taking shape in our minds before becoming reality. This is where it starts.

我们决心打破现状，开辟一条新路。就在现在，采取行动！实现这一愿景需要我们改变运营方式，并且需要所有相关人员坚定不移的承诺。记住，每一次变革都始于一个愿景，一个在我们脑海中成形的理念，然后才成为现实。这就是起点所在。

Janet Woodcock, M.D.