Regulation of pharmaceutical product

This brief survey of the FDA regulation of pharmaceutical products demonstrates the breadth and depth of FDA activity in this field. Although there are repeated calls for reform of the IND/NDA system, it appears unlikely that any substantial change will occur in the near future. It is therefore important that any person who enters the prescription drug industry in the United States be fully informed about the requirements, understand the regulatory risks involved, and comply adequately with all of the FDA requirements. 

Cuba, which has the longest dmg regulation experience in this group, issued its royal act Real Tribunal Protomedicato in 1709 to control the conduct of professionals, rather than pharmaceutical products themselves. Before the industrialization of pharmaceutical production, dmgs were made up and dispensed to individual patients in pharmacies. Accordingly, attempts to protect patients were aimed first at the activities of the professionals who practised pharmacy rather than at the products themselves, which at that time were being manufactured on a small scale only. 

Each dmg regulatory function helps to ensure the efficacy, safety and quality of pharmaceutical products and their rational use. Dmg regulation should therefore be carried out in such a way that each function receives sufficient attention and resources. Yet experiences in the countries studied indicate that the different dmg regulatory functions receive varying degrees of emphasis. The disparities are found in three key areas. 

European Aspects of the Regulation of Drug Products with Particular Reference to Development Pharmaceutics... 

Price differences between countries owing to regulation and control systems create incentives for parallel trade of pharmaceutical products, whereby drugs from a country with low prices are imported into other countries with higher prices and resold there (see Chapter 5). 

Licensing may come sometime, Campbell wrote after the new law had gone into effect, but the climate was not right for it in 1938 (90). "Meanwhile, there seems no alternative. . . except to undertake, through the gradual development of powers that have been conferred upon us by. . . section 505 and the authority to make factory inspections, a more effective regulation of the production and marketing of pharmaceutical products than was possible under the old statute.. .."... 

Each Member State of the European Union operates its own policy regarding the pricing of pharmaceutical products. In the United Kingdom, the primary tool is the Pharmaceutical Price Regulation Scheme (PPRS), which is better described as a profit-regulating scheme. This is dealt with in detail in Chapter 26. 

Generic Drug Enforcement Act of 1992. The following sections summarise some of the more important enforcement provisions used by FDA to regulate all pharmaceutical products. 

Even between high-income countries, there are appreciable differences in prices of pharmaceutical products (Danzon and Furukawa 2003). Such differentials have led to some price arbitrage as occurs with parallel imports for example, manufacturers in Country A, with high retail prices for pharmaceutical products, exports to Country B these products with lower prices because of government regulation of the prices of such products or price discrimination, and Country B in turn exports to Country A but at the prices of Country B. 

Since the mid-1970s validation has become an increasingly dominant influence in the manufacture and quality assurance of pharmaceutical products. In 1976 the FDA proposed a whole set of current GMP regulations which were revised several times. 

Pharmaceutical cGMPs for the 21st Century was intended to enhance and modernize the regulation of pharmaceutical manufacturing and product quality. This report provides an overview of the PAT Team s and Manufacturing Science Working Group s collaborative efforts, accomplishments, and points to consider as the initiative moves into its next phase (implementation and continuous improvement). 

The cGMP regulations for the manufacture of pharmaceutical products are contained in Parts 210 and 211 of Title 21 of the Code of Federal Regulations (CFR) [1]. These regulations, as well as guidance documents and other FDA documents... 

As noted above, sensitive and specific GC-MS/MS methods for the determination of 3-OH FAs and Mur have been developed. MS is an alternative to the classical LAL assay for determination of LPS, while no other regulated approach exists for PG assessment. These chemical methods are reproducible and provide quantitative, accurate determination of microbial biocontamination. At the present time mass spectrometric measurement of LPS and PG have matured sufficiently to be used for routine assessment of air quality. Numerous products of medical and environmental origin have been analyzed. However, use for assessment of pharmaceutical products remains limited. 

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