Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)

Mandatory Reading:

• Regulatory Affairs (Reg)
• Intellectual Property (IP)
• Quality Assurance (QA)
• Legal Department

Work Suggestions:

• Reg: Ensure the company's drug applications comply with the new drug application procedures and bioequivalence standards.
• IP: Monitor patent term extensions and the impact on the company's patent strategy.
• QA: Verify that manufacturing processes meet the identity, strength, quality, and purity requirements.
• Legal Department: Advise on patent infringement issues and the legal implications of abbreviated new drug applications.

Scope of Application:
The Drug Price Competition and Patent Term Restoration Act of 1984 applies to chemical drugs, including new molecular entities and generic drugs, in the United States. It is intended for regulatory bodies, pharmaceutical companies, and legal entities involved in drug development and approval processes.

Key Points Summary:

1. Abbreviated New Drug Applications (ANDAs): The Act allows for the streamlined approval of generic drugs by submitting abbreviated applications showing bioequivalence to the listed drug, without repeating costly and time-consuming clinical trials.

2. Patent Term Restoration: Offers a mechanism to extend the effective patent life of a drug to partially compensate for the time lost during the regulatory review process, up to a maximum of five years.

3. Data Exclusivity: Provides a period of data exclusivity, during which the FDA cannot approve ANDAs for other companies that rely on the innovator's safety and efficacy data.

4. Patent Certification: Requires ANDA applicants to certify about the listed drug's patents or periods of exclusivity, which can trigger a patent infringement lawsuit.

5. Regulatory Review Period: Defines the regulatory review period for calculating patent term extensions and sets rules for due diligence during the application process.

Conclusion:
The Drug Price Competition and Patent Term Restoration Act of 1984 is a landmark legislation that balances the need for accessible, affordable medications with the incentive for innovation. It has significantly impacted the pharmaceutical industry by fostering competition and ensuring that both innovator and generic drug companies have clear pathways to market. The above points are not exhaustive; for comprehensive understanding, the full text of the Act should be consulted.

适用岗位：

• QA（质量保证）
• 注册
• 市场
• 研发

工作建议：

• QA：监控标签变更的合规性，确保所有标签变更都符合FDA的最新规定。
• 注册：负责提交CBE-0补充申请，确保及时更新药品和生物制品的标签信息。
• 市场：在推广材料中使用更新后的标签信息，避免因标签信息不一致而导致的误导。
• 研发：在研发过程中收集的数据，若影响产品标签，需及时通知注册部门进行变更。

适用范围：
本文适用于已批准的化学药和生物制品的标签变更，包括创新药、仿制药、生物类似药和原料药，由美国FDA发布，适用于Biotech、大型药企、跨国药企以及CRO和CDMO等各类企业。

要点总结：

1. 标签变更补充申请（CBE-0）：FDA提议允许ANDA持有者提交CBE-0补充申请，以临时更改产品标签，反映新获得的信息，与RLD标签不同。
2. 信息公开：FDA将建立一个专门的网页，公开CBE-0标签补充申请中的标签变更信息，以便医疗保健提供者和公众在FDA审查期间获取。
3. 一致性要求：所有ANDA持有者在FDA批准RLD标签变更后，必须在30天内提交CBE-0补充申请，以符合标签变更。
4. 标签变更的批准：对于RLD标签的安全性变更，一旦获得批准，相应的ANDA补充申请也将获得批准。
5. ANDA标签差异的例外：FDA提议增加一个例外，允许因CBE-0补充申请而导致的ANDA标签与RLD标签的临时差异。

以上仅为部分要点，请阅读原文，深入理解监管要求。

必读岗位及工作建议：

• QA（质量保证）：负责确保原料药生产全过程符合质量管理规范，监控质量体系运行。
• QC（质量控制）：负责原料药的质量检测，确保产品质量符合标准。
• 生产：负责按照GMP要求进行原料药的生产操作，确保生产过程合规。
• 工程：负责厂房设施和设备的维护保养，确保生产环境和设备符合要求。

适用范围：
本文适用于化学药领域的原料药生产，包括创新药和仿制药，适用于大型药企、跨国药企以及CRO和CDMO等企业类别，发布机构为国际通用标准。

文件要点总结：
原料药的生产质量管理规范强调了从质量管理到生产控制的全过程管理。首先，文件明确了质量管理的原则和机构职责，特别强调了质量保证和质量控制的重要性，并规定了自检、产品质量回顾以及质量风险管理的具体要求。在人员方面，规定了资质、培训和卫生要求，确保员工符合岗位需求。厂房与设施章节详细规定了设计建造、公用设施和特殊隔离要求，以保证生产环境的适宜性。设备章节则涉及设计建造、维护保养、校准和计算机化系统的要求，确保设备运行的可靠性。文件还特别提到了无菌原料药的生产特点，包括生产工艺、厂房设施设备设计、生产过程管理以及环境控制等，这些都是确保原料药质量的关键环节。

以上仅为部分要点，请阅读原文，深入理解监管要求。