The Regulatory Objectives

To support approval as a nonbotanical drug, adequate and well-controlled clinical studies are required. Not only must the treatment be shown to be effective, with real patient benefits in morbidity and/or mortality to justify the safety risk of adverse reactions as observed, but the clinical data must also provide practical instructions for use, which can be reasonably followed by health care professionals. There is no reason why these requirements should be different for botanical drugs, because patient suffering and treatment benefits are independent of medical theory or practice. Regardless of medical systems and terminology used, courses of diseases/conditions should be established and treatment effects must be clinically meaningful. Incorporation of alternative medical practice into the clinical studies will be acceptable if the new set of instructions derived from such studies will be practical. 

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Ultimately the technical objective of an analytical procedure, which is included as part of a registration application for pharmaceuticals, is the responsibility of the analytical department. This objective is directly related to the regulatory objective as defined by the regulatory professionals. For example, the regulatory professionals require a means to quantitate an API in a finished pharmaceutical for release between 95-105% of label claim. This translates into a technical objective for the analytical chemist that involves the selection of an analytical technique and the development of a method that has the required accuracy and precision to meet the requirements for release. 

For regulatory control, repeatability is of major interest. The basic-objective of regulatory control is to maintain uniform process operation. Suppose that on two different occasions, it is desired that the temperature in a vessel be 80°C. The regulatoiy control system takes appropriate actions to bring the measured variable to 80°C. The difference between the process conditions at these two times is determined by the repeatability of the measurement device. 

A successful tolling project depends upon defining the project objectives at the outset and clearly communicating those objectives. The objectives take into account the rights and expectations of both the toller and the client. Specifics such as ownership, specifications, timing, regulatory requirements, product quality, and documentation are considered. Each project or process is unique and consequently the agreements reached between the parties and the... 

We begin by reviewing the regulatory driving force in the United States for air pollution abatement. To appreciate the objectives of our Federal air pollution control regulations, an understanding of the fate and transport mechanisms in the environment is important. Hence, some general discussions on the behavior of pollutants in the atmosphere are included in this chapter. 

The majority of non-clinical studies are undertaken in the pre-clinical phase of drug development. These studies serve both to guide the developer and satisfy the regulatory authorities. The objectives of this phase can be summarised as follows ... 

Dmg regulatory authorities in each of the countries produce an annual or quarterly report, the contents of which vary. The study in Cyprus specifically pointed out that the annual reports of its DRA are mostly activity reports, with no comments about the extent to which the set objectives have been achieved. 

The first three objectives relate to pharmaceutical products, and the fourth to pharmaceutical usage although, in most countries, promoting rational use of dmgs is not part of regulatory activities. In order to achieve the four objectives, the various pharmaceutical activities— manufacturing, importation, exportation, distribution... 

Educating consumers about the efficacy, safety, quality and rational use of dmgs can also enhance the achievement of regulatory objectives. 

A clear sense of the mission of the regulatory authority is important in motivating DRA staff to pursue regulatory processes in order to achieve dmg regulation. Governments should state clearly the mission and objectives of dmg regulation, so that the attainment of the intended objectives can be easily assessed. 

Plant metabolism studies will provide information on the absorption, translocation, dissipation and degradation of the agrochemical. This information defines the residual analytes of regulatory concern that could include either the parent compound or metabolites in the field crops. Plant metabolism studies should be conducted with at least three crop representatives of three different crop groups listed in Table 1. One of the major objectives is to determine the comparative metabolism of the agrochemicals between animals and plants among different plant species. MAFF approves metabolism studies that are conducted in foreign countries, which should be operated under the certified GLP system. 

Unlike the FDA, the EMEA itself does not directly undertake appraisals of drug dossiers submitted to support marketing authorization applications under the centralized procedure. Instead (as discussed in detail below), they forward the dossier to selected national EU regulatory bodies, who undertake the appraisal, and the EMEA makes a recommendation to approve (or not) the application based upon the national body s report. The overall role of the EMEA is thus to coordinate and manage the new system. The EMEA s annual budget is of the order of 120 million. The key objectives of the EMEA may be summarized as ... 

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