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.

法规指南解读

适用岗位：

• 必读岗位：注册专员（Regulatory Affairs Specialist）、质量保证专员（QA）、研发人员（R&D）、临床研究协调员（CRC）。
• 工作建议：
  • 注册专员：熟悉FDA现代化法案的条款，确保注册流程符合最新法规要求。
  • 质量保证专员：监控法规变化，更新质量管理体系。
  • 研发人员：在药物开发过程中考虑法规要求，确保研发合规。
  • 临床研究协调员：确保临床试验遵循FDA现代化法案规定。

适用范围：
本文适用于美国药品、生物制品、医疗器械和食品的监管，适用于所有在美国运营的药企、生物科技公司、CRO和CDMO等。

文件要点总结：

1. 法规修订：明确了对《联邦食品、药品和化妆品法》及《公共卫生服务法》的修订，以改善食品、药品、医疗器械和生物制品的监管。
2. 定义明确：为“药品”、“医疗器械”、“食品”和“膳食补充剂”等术语提供了明确的定义。
3. 监管改善：分为五个部分，分别针对药品、医疗器械、食品的监管进行改善，并包含一般规定和生效日期。
4. 强调合规：通过修订法规，强调了对药品、医疗器械和食品的合规性要求。
5. 监管现代化：旨在通过现代化法案，提高监管效率和确保公共健康安全。

以上仅为部分要点，请阅读原文，深入理解监管要求。