Скачать или смотреть Regulatory Framework for Medicinal Product Distribution in the United States: An Overview

Author: Dr. #PooyanGhamari, Swiss Visionary

Food and Drug Administration (FDA) - https://www.fda.gov/

The Code of Federal Regulations (CFR) - https://bookstore.gpo.gov/catalog/cfr....

Introduction:
The distribution of medicinal products within the United States is underpinned by a comprehensive regulatory framework designed to safeguard public health by ensuring the safety, efficacy, and quality of pharmaceuticals. This framework is enforced by the Food and Drug Administration (FDA), which oversees the entire lifecycle of medicinal products, from preclinical development to post-market surveillance. The FDA's regulatory purview encompasses the approval of new drugs, generic drugs, over-the-counter medicines, and the rigorous inspection of manufacturing and distribution practices.

Good Manufacturing Practice (GMP) in the U.S.:
In the United States, the Code of Federal Regulations (CFR) Title 21 Part 210 and 211 outline the GMP requirements for pharmaceutical products. These regulations are enforced by the FDA and dictate the minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The aim is to ensure that products are safe for use, and that they possess the identity and strength, and meet the quality and purity characteristics that they purport or are represented to possess.

Good Distribution Practice (GDP) in the U.S.:
While the U.S. does not have a specific set of GDP guidelines as in the EU, the distribution practices are covered under the Drug Supply Chain Security Act (DSCSA), which was enacted in 2013. The DSCSA outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This system enhances the FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

The DSCSA requirements are being phased in over a 10-year period, with key provisions that include product identification, tracing, and verification, as well as detection and response mechanisms for the pharmaceutical distribution supply chain.

Interconnectivity of GMP and GDP in the U.S.:
The interconnectivity of GMP and GDP is as crucial in the U.S. as it is in the EU. The FDA ensures that pharmaceutical companies adhere to GMP during the manufacturing process, and the DSCSA provisions extend this regulatory oversight through the entire supply chain to the final point of dispensation. The principles of GMP serve as the foundation for GDP, ensuring that the product's quality is maintained throughout its distribution.

New Drug Approval Process:
The FDA's Center for Drug Evaluation and Research (CDER) is responsible for the new drug approval process. This involves a rigorous review of clinical trial data, labeling, and the manufacturing and control processes to ensure that the drug is safe and effective for its intended use and that the benefits outweigh the risks.

Post-Marketing Surveillance:
Once a drug is on the market, the FDA continues to monitor its safety, mandating the reporting of adverse events and periodically inspecting manufacturing and distribution facilities. The FDA's post-marketing surveillance includes the use of MedWatch, a system designed for the voluntary reporting of adverse events by healthcare professionals and consumers.

Conclusion:
The medicinal product distribution framework in the United States reflects a robust commitment to public health, paralleling the stringent regulations found in the European Union. The FDA's regulatory oversight ensures that pharmaceuticals meet the country's safety and efficacy standards from the point of manufacturing to the moment they reach the consumer. Adherence to GMP is the cornerstone of quality pharmaceutical manufacturing, while the DSCSA governs the secure and efficient distribution of medicinal products.

Dr. Pooyan Ghamari’s exposition on the U.S. regulatory framework underscores the significant role of regulatory agencies in ensuring that medicinal products are not only effective but are distributed in a manner that maintains their quality and integrity, ultimately safeguarding the well-being of the American public.