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Medicine plays a significant role in everyday life of each individual. Drugs support individuals in treatment and prevention of diseases and, thus, they have to be examined and regulated by appropriate laws. The development of drug regulations depends on the progress of scientific and technological innovations. Thus, history of drug regulations is characterized by scientific revolution in the specific fields that has been lasting for hundreds of years and continues to progress. At the same time, pharmacological laws and regulations are important for the entire society because they protect public health. Moreover, there are certain regulatory institutions and establishments that conduct specific activities and functions to examine and test medical products. However, although future of drug regulations is quite promising, contemporary issues together with potential problems are important to consumers and regulatory organizations. Therefore, drug regulations have a long history that contributed to the development of pharmacological laws and guidelines, which ensure safety and high quality medicine.
The challenge to provide population with safe and effective drugs has developed gradually over the time. For instance, the drug Mithridatium invented by Mithridates VI was considered as the universal remedy for all illnesses until the end of 18th century. In England, the production of Mithridatium together with other drugs became subjected to governmental control only in the middle of 16th century. To be precise, the Apothecaries Wares, Drugs and Stuffs Act can be regarded as one of the earliest drug regulations in Great Britain. In this respect, it could be considered to the first step towards the development of drug regulations. In 1240, the official books, which specialized on medicine quality standards, known as Pharmacopoeias, were issued. The first Pharmacopoeias familiar to contemporary pharmacologists stared to be issued in Europe, specifically in Spain in 1581.
The modern history of drug regulation starts in the 19th century due to scientific progress in such fields as chemistry, physiology and pharmacology. The chemotherapeutic revolution greatly contributed to the modern drug research, which was launched after the World War II. Moreover, the unfortunate event supported the progress in drug regulations. In 1937, in the United States, 107 people including children died after taking drugs, which contained diethylene glycol – a solvent that was chemically similar to antifreeze. This accident reinvigorated the government to place The Federal Food, Drug and Cosmetic Act in 1938. Another horrible event, which facilitated the development of such regulations further, took place in Western Germany in 1956. Thalidomide, a tranquilizing and hypnotic drug, which was sold worldwide, caused more than 10,000 babies to be born with deformities. Hence, British regulatory system underwent certain changes. In 1963, a Committee on the Safety of Drugs (CSD) was created. Compared to Great Britain, the United States also took specific measures. Thus, Congress passed the Drug Amendments Act demanding the FDA to verify all new drug applications (NDA).
In 1990s, inside the EU, a common market for drugs was created. In this respect, the harmonization of requirements and regulations on the medicines became a necessity. Hence, in 1990, the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) was established. The collaboration between the United States, the EU, and Japan focused on pharmaceutical regulation of new, innovative drugs. This supports the control over development and production of safe, effective and high quality medicines. Within the United Nations system, World Health Organization (WHO) is responsible for the coordination on regional, national, and international levels. In addition, the organization is in control of global health matters, since it sets norms and standards, provides technical support to countries, and monitors health trends. Thus, drug regulation on international level supports consensus on safety, quality, and effectiveness of new medicine.
Since drugs are not ordinary products, which consumers can buy without any consequences, it is crucial to regulate their safety and quality. In most instances, customers are not able to make decisions on what medications to take, when and how often. Indeed, there are many potential risks because no drug is completely safe. The use of ineffective, harmful, and law-quality medicine can result in exacerbation of the disorder or even death. It also undermines people’s confidence in health professionals and health system in general. In this respect, to protect ordinary consumers, government needs to confirm the safety of the medicine by establishing specific laws and regulations. Moreover, the regulatory officials are established on regional and national levels to ensure that production, trade, and use of drugs remain under control according to specific standards. Thus, pharmacological laws and regulations are necessary to avoid unfortunate health situations.
Furthermore, the production of drugs and their distribution also requires appropriate knowledge and skills. While governments have the responsibility to protect its citizens, national regulatory authorities are established to promote public health. Drug regulation requires the implementation of sound scientific knowledge and expertise. At the same time, passing new laws and regulations requires time because it demands final approval of the country’s legislative branch. Sometimes regulations can be passed more rapidly because they require only agreement of a single government minister. Moreover, drug regulations can undergo certain changes or updates during the process of their approval. Once the government approves the regulation, it has the same power as the law. In addition, pharmacists include many parties that work for a while before accepting the appropriate drug policy. The basic information about effective drug regulation is offered in several WHO documents.
At the same time, countries need effective medicine regulations despite the existence of national drug policies. The drug control may take a form of a law or regulation on the national level that involves a number of complementary laws. Furthermore, a law on medications has to define clearly the obligations of each party, including manufacturers, pharmacists, and distributors. It is a necessary step in avoiding all possible misunderstanding between the parties. For example, medicine registration laws represent the responsibilities of a manufacturer who wants to get a license to sell drugs. Hence, medicines laws and regulations are supposed to be used together to reach their ultimate purpose. It takes a long time to create an appropriate drug law or regulation and then pass it. Thus, drug regulation is a gradual process that involves different officials and parties, who are responsible for safety of the public health.
Medicines regulation includes certain strengthening activities that aim to promote and protect public health. These activities involve various functions, such as licensing of the manufacture, distribution, and advertising of drugs; evaluating the safety, quality, and efficacy of products; verifying of manufacturers, importers, and distributors of medicines; controlling the quality of drugs on the market; providing the masses with independent information on medicines. To regulate medicines effectively, appropriate medical, scientific and technical skills have to be applied within a legal framework. Thus, among the regulatory functions, communication with different parties (manufacturers, distributors, consumers, and governments) occupies a leading place because their interests, as well as economic, social and political motives may vary. Hence, drug regulation, specifically its execution, can be politically and technically challenging. Although drug regulation includes administrative part, the scientific ground tends to be more important. Despite the complications, medicines regulations are aimed at all products to be safe, of good quality, and effective.
At the same time, decisions on drugs quality, safety and efficacy should be made basing on scientific conclusions. In this respect, there is a number of regulatory functions for a national regulatory authority (NRA). The organization has to ensure that all medicines and connected to their production establishments are licensed. Moreover, it is in charge of estimation and evaluation of safety, efficacy and quality of drugs before they appear on the market. NRA also inspects the informal market, including advertising to prevent illegal commerce of medicines. The organization participates in regional and international meetings of medicine regulations to examine issues of mutual concern and to exchange the necessary information. In addition, NRA estimates and evaluates performance of separate establishments in order to identify weaknesses and make the needed changes.
Furthermore, excessive promotion and advertising of pharmaceuticals was related to serious problems due to unreasonable drug use. Since unethical medicines campaign activities usually possess misleading information about products, it can be very harmful for the consumers’ health. Misinformation can include the exaggeration of efficacy or downplaying the seriousness of wrong use or adverse reactions. Such acts result in wrong perception of drug safety and efficacy. In many countries, the possibility of such situations and solutions are discussed in legislation. For instance, medicines regulation on the specific product underlines that only information confirmed during the registration process can be used in advertising materials. Thus, laws and regulations connected to health usually consider the right of consumers. In addition, WHO has created guidelines on Ethical Criteria for Medicinal Drug Promotion, which greatly supports protection of patient’s right. Therefore, medicine regulations are characterized by certain activities and functions, which are necessary to satisfy governmental and consumer requirements.
While drug regulation has a direct link to the development of the sciences involved in the production of new drugs, it also depends on the current technological and scientific progress. Moreover, drug regulations are interested in safe and effective treatments because passing of laws may take not only years, but also may require huge expenses. Indeed, a cost of research and development is increasing. At the same time, quality issues remain a problem due to poor quality of materials, dosage forms, and fake medicines. In this respect, new technologies and new scientific developments will produce new regulatory challenges. To be precise, using nanotechnologies will make a significant change in the medicines regulation. Thus, the understanding of collaboration between the nanoparticles and human organs is importance when developing new drugs. In addition, improving appropriate knowledge of molecular biology is also necessary for the development of innovative medicines, as well as their regulations.
Nevertheless, certain important quality issues can rise. For example, economic landscape remains a vulnerable area when speaking of medicine regulation. While the budget of new emerging economies competes with budget deficits in old economies, drug regulations continue to exist in challenging environment. At the same time, pharmaceutical manufacturing should follow the demands of global market. Furthermore, the development of new technologies will allow achieve high tech diagnostics solutions. In addition, relative efficacy of medicines is also one of the most vulnerable concerns connected to drug regulations. Increasing public concerns about safety and price of medical products rise the necessity of patients’ involvement in the regulatory process. Thereby, the appropriate solutions should be found to battle the possible problems in the near future.
Additionally, some old issues connected to drug regulations continue to exist. For example, in many countries, there are no regulatory institutions to provide the population with the necessary medicine regulations. In this respect, not all new innovative products, which appear on the market, are inspected appropriately. In spite of some progress in the specific field, the gap between resources of different regulators remains the issue. Thus, market control is an outstanding problem that requires further investigations. In addition, public concern about scientific assessments is another issue that calls for an effective solution.
Therefore, drug regulations underwent a long history of progress and unfortunate events. Accidents connected to the use of drugs show that pharmacological laws and regulations are necessary for public health. At the same time, medicine regulations include certain regulatory establishments on the regional and nation levels. These institutions possess specific activities and functions in order to conduct the entire procedure of drug regulations. Although there are contemporary issues related to medicine regulations, the future of the particular field is promising.
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