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.

岗位必读建议：

• 注册专员：熟悉ANDA提交的拒绝接收(RTR)标准，确保提交文件的完整性和合规性。
• 质量保证专员(QA)：理解产品质量缺陷部分的RTR标准，保证产品质量符合FDA要求。
• 研发人员：关注原料药(API)审查和生物等效性(BE)研究的RTR标准，确保研发过程和结果的合规性。
• 临床研究协调员：了解临床缺陷相关的RTR标准，保证临床研究的充分性和适当性。

文件适用范围：
本文适用于化学药品的仿制药(ANDA)提交，包括新强度的事先批准补充(PAS)。适用于美国FDA的监管框架，主要针对原料药、制剂、生物等效性研究和临床缺陷的审查。

文件要点总结：

1. RTR决策标准：强调了FDA拒绝接收(RTR)ANDA的具体情形，如资料不完整或存在重大缺陷。
2. ANDA完整性：明确了ANDA被视为实质上完整，能够进行实质性审查的标准。
3. 通用政策：描述了FDA如何评估ANDA中识别的缺陷，以及如何确定是否接收ANDA。
4. 原料药审查：强调了API审查中起始物料和无菌保证数据的重要性。
5. 产品质量缺陷：列举了可能导致RTR的产品质量问题，如非活性成分、稳定性、包装量、批记录等。
6. 生物等效性和临床缺陷：概述了BE研究失败、替代BE研究、Q1/Q2一致性要求、溶出数据不足等问题。

以上仅为部分要点，请阅读原文，深入理解监管要求。