European Regulation (EC) No. 1394/2007

Definition

European Regulation (EC) No. 1394/2007 is a legislative framework established by the European Union to regulate advanced therapy medicinal products (ATMPs), including gene therapies, somatic cell therapies, and tissue-engineered products. This regulation aims to ensure the safety, efficacy, and quality of these innovative treatments while fostering their development and access in the EU market.

5 Must Know Facts For Your Next Test

1. Regulation (EC) No. 1394/2007 came into effect on December 30, 2008, marking a significant step in the regulation of advanced therapies within the EU.
2. It provides a legal definition for ATMPs, categorizing them into gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products.
3. The regulation establishes clear pathways for the authorization of ATMPs through centralized marketing authorization by the EMA, facilitating easier access to these therapies across EU member states.
4. Safety monitoring is a key aspect of the regulation, requiring ongoing pharmacovigilance to track the effects of ATMPs once they are on the market.
5. The regulation emphasizes the need for robust manufacturing processes and quality control measures to ensure the integrity and reliability of advanced therapies.

Review Questions

• How does European Regulation (EC) No. 1394/2007 define Advanced Therapy Medicinal Products (ATMPs) and what categories does it include?
  • European Regulation (EC) No. 1394/2007 defines Advanced Therapy Medicinal Products (ATMPs) as products based on genes, tissues, or cells intended for human use. The regulation categorizes ATMPs into three main groups: gene therapy medicinal products that modify genetic material; somatic cell therapy medicinal products that involve the administration of cells; and tissue-engineered products that incorporate cells and tissues designed to repair or replace damaged tissues. This clear classification aids in the appropriate regulatory oversight of each type.
• Discuss how European Regulation (EC) No. 1394/2007 facilitates the marketing authorization process for ATMPs within the EU.
  • European Regulation (EC) No. 1394/2007 establishes a centralized marketing authorization process through which Advanced Therapy Medicinal Products can gain approval from the European Medicines Agency (EMA). This means that once an ATMP is authorized by the EMA, it can be marketed in all EU member states without needing separate approvals from each country. This streamlined process is intended to encourage innovation and provide faster access to potentially life-saving treatments for patients throughout Europe.
• Evaluate the impact of European Regulation (EC) No. 1394/2007 on the development and oversight of gene therapies within the EU market.
  • European Regulation (EC) No. 1394/2007 has significantly impacted the development and oversight of gene therapies by providing a comprehensive regulatory framework aimed at ensuring their safety, efficacy, and quality. By establishing specific categories and pathways for ATMPs, this regulation has encouraged research and investment in gene therapies while maintaining strict guidelines for clinical trials and post-market surveillance. The emphasis on pharmacovigilance enhances patient safety by ensuring ongoing monitoring of adverse effects, ultimately fostering trust in these innovative therapies within the healthcare system.

Related terms

Advanced Therapy Medicinal Products (ATMPs): Medicinal products that are based on genes, tissues, or cells, intended for human use, which can provide new treatment options for various diseases.

European Medicines Agency (EMA): The regulatory authority responsible for evaluating and supervising medicines in the European Union, including ATMPs under Regulation 1394/2007.

Clinical Trials Directive: A set of regulations in the EU that governs the conduct of clinical trials involving medicinal products to ensure safety and ethical standards.