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.

必读岗位及工作建议

• QA: 确保公司的质量保证体系符合M9指南要求，监控产品质量。
• 注册: 在药品注册过程中，依据M9指南准备和提交生物等效性豁免的申请。
• 研发: 在药物开发阶段，根据生物药剂学分类系统设计药物，确保满足M9指南的生物等效性豁免条件。

文件适用范围

本文适用于需要证明生物等效性的化学药和生物制品的固体口服速释剂型或悬浮剂，不包括具有狭窄治疗指数的药物和固定剂量组合(FDC)产品（除非所有组分均满足M9指南标准）。适用于Biotech、大型药企、跨国药企等，由ICH发布。

文件要点总结

1. 生物等效性豁免原则：基于生物药剂学分类系统(BCS)，减少体内生物等效性研究的需求，通过体外数据支持体内性能的等效性。
2. 药物物质的生物药剂学分类：根据药物物质的水溶性和肠道渗透性特征，将药物分为四个BCS类别。
3. 生物等效性豁免的适用性：适用于BCS I类和III类药物，要求药物产品为口服速释剂型，且与参比制剂剂量形式和强度相同。
4. 辅料考量：评估辅料差异对药物吸收的影响，确保辅料差异不会影响药物物质的吸收特性。
5. 体外溶出度测试：为BCS I类和III类药物提供体外溶出度测试要求，确保测试产品和参比制剂的溶出行为相似。

以上仅为部分要点，请阅读原文，深入理解监管要求。