Pharmaceutical products regulating

Pharmaceutical products are not sold or supplied before a Qualified Person has certified that each production batch has been produced and controlled in accordance with the requirements of the Marketing Authorisation and any other regulations relevant to the production, control and release of medicinal products. 

Documentation is at the core of all quality systems, and was discussed in Chapter 2. Examples of the types of documentation associated with pharmaceutical production are shown in Figure 11.9. European regulations require that records which permit tracing of the full history for each batch of product should be retained for 1 year after expiry of the product or 5 years, whichever is the longer. US regulations require the retention of records for 1 year after batch expiry or 3 years after the last distribution in cases of some OTC products where no expiry date is assigned. Additionally, the US regulations require the preparation of a Master Production and Control Record ,... 

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. 

Cuba stands out as the only country in this group that permits neither dmg advertising nor dmg promotion. Instead, pharmaceutical products are distributed and product information disseminated within the Ifamewoik of the centralized State-mn management system. Misinformation for commercial purposes is therefore not an issue in Cuba. In all the other survey countries, both the content and the conduct of dmg advertising and promotion are regulated. The basis of such controls is found in dmg legislation. 

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. 

For all pharmaceutical products, it must first be assured that the drugs will be prepared under conditions that will assure them to be safe and to have the identity and strength as stated by the manufacturer. The regulations require a complete description of all that is involved with the manufacture of the dosage form. 

There is a long-standing habit in the health economics literature of supporting the need to regulate health care services in market failures such as information asymmetries, complexity and uncertainty, indivisibilities and externalities. These imperfections are also present in the market of a resource that is very important in the health service production process pharmaceutical products. However, the pharmaceutical market also presents certain specific characteristics that are of particular importance and have been used as arguments in favour of the need to adopt public policies of price intervention and regulation. 

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). 

European pharmaceutical markets are strongly regulated as regards the introduction of new products onto the market (through authorization and patents) and also as regards prices and consumption (medical prescription and public financing). However, the way in which entry, prices and consumption of pharmaceuticals are regulated varies enormously from country to country. 

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.. .."... 

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