The field of pharmacology has grown complicated in the past years. Pharmaceutical companies have become larger, procedural processes are more complex and clinical trials have become more decentralized and outsourced. To govern and regulate this field in health care, there are several worldwide and local agencies that exist as regulating bodies. Examples of such organizations include the World Health Organization (WHO), the U.S.
Food and Drug Administration (FDA) and the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) to name a few.The main goal of these agencies is to promote public health by ensuring the quality, safety and efficacy of medicines available in the market. This is accomplished through dissemination of information necessary for rational use of medicines; monitoring of manufacturing, dispensing, storage and distribution practices; detecting and sanctioning illegal manufacture and trade of drugs; and making sure that advertising and promotion of drugs are fair, rational and balanced (World Health Organization [WHO], 2008).The main function the WHO has in drug regulation is the coordination of and with Drug Regulation Authorities developed by each country and thus has a two-pronged role: first “the development of internationally recognized norms, standards and guidelines” and second, “to provide guidance, technical assistance, and training” to allow countries to adapt to global guidelines (WHO 2008). The FDA on the other hand has varying responsibilities that mostly include ensuring food, cosmetics and drugs are fit and safe for consumption. The agency also “monitors the manufacture, import, transport, storage, and sale of $1 trillion worth of goods annually” under the authority to enact the Federal Food, Drug and Cosmetic Act.
The following are the products which the FDA regulates: biologics, cosmetics, drugs, medical devices, radiation emitting electronic products and veterinary products. The FDA website lists a comprehensive catalogue of laws enacted by and affecting the FDA (U.S.
Food and Drug Administration [FDA], 2008).Part of the duties of these regulating bodies is to oversee the production of new drugs and make sure that these drugs undergo rigorous clinical trials and testing before they are made available to the public. Under the international guidelines, new experimental drugs must first be rigorously tested on animals under protective laws such as Animals (Scientific Procedures) Act of 1986. After promising results from animal trials, human clinical trials are performed under a three-phase process. The three phases are described as follows:Phase I trials are conducted with typically 10-50 healthy subjects.
“This determines the early safety profile and pharmacokinetic profiles (pattern of drug distribution and metabolism).Phase II trials are conducted on patients with a specified disease (typically 100-200) to determine preliminary effectiveness, optimal dosages and expanded evidence of safety.Phase III is a large-scale (typically >1,000), multi-centre, comparative clinical trial with patients with the target disease to provide sufficient data to statistically evaluate the effectiveness and safety of the product. This results in the refinement of manufacture techniques and formulation. Additional safety studies will be required, e.g. long-term toxicology studies (>12 months) and carcinogenicity studies (Pharmaxis, 2008).
This process is accomplished under certain regulatory laws, such as the Guidance for Industry on CGMP for Phase 1 Investigational Drugs an example from the US FDA (US FDA, 2008). However the modern structure of pharmaceutical companies have recently developed a trend towards Clinical Resource Outsourcing and the US FDA responded by heading a new initiative towards the modernization of the Clinical trials and Bioresearch Monitoring regulatory guidelines. Under this renewed initiative, the “Human Subject Protection and Bioresearch Monitoring (HSP /BIMO) Initiative will facilitate the modernization of the regulation of clinical trials and bioresearch monitoring, specifically the protection of human subjects and the integrity of data in clinical trials, and encompasses devices, foods, human drugs, biological drug products and veterinary medicine” (US FDA 2006).