Generic drug that is equivalent to the original - the key to the affordability of modern pharmacology.
• Generics are equivalent to generic medicinal products, which can be marketed after their patent protection.
• Generics contain the same active substance, meet the same requirements during the development, production and safety assessment activities.
• Generics are developed either as a brand, with its own trademark, (eg Ibalgin � contains the active ingredient ibuprofen) or unbranded, using the simplified name of the appropriate substance (eg Fluconazole, Chlorprothixen).
What is the importance of generic drugs
• They are available at a lower price and thus increase the availability of modern drugs. Generics are available at a price of 20% to 80% lower compared with the prices of original drugs. With their quality, efficacy and safety are the same.
• encourage innovation and competition, because they are competing for the original products. If the original medication was a monopoly, there would be no reason for further innovation.
• Between generics and original medicines are no discrepancies. Widespread use of generic equivalents leads to savings that can be used for a wider use of more expensive original drugs, where really necessary.
Why is equivalent to the original drugs are cheaper than original drugs
• It has the original patent-protected monopoly, and therefore its price may be higher.
• If you do not have generic equivalents to repeat all the preclinical and clinical research can be applied to the clinical data of the original product. Therefore, the R & D are much less expensive.
How safe and effective generic equivalents
• Before the launch of all medicines must go through the registration process. In Europe the registration process takes place at the European Institute for Drug Control. During the registration process is assessed safety, quality and efficacy. This means that if the drug is registered, its safety, efficacy and quality are confirmed by law. During the registration process, apply the same criteria for generic equivalents and for the original drugs.
• Registration is valid for 5 years. During this period, the manufacturer is required to evaluate the safety of the preparation, not only his own, but also all the other containing the same active substance. The condition of renewal is to provide a comprehensive report for the entire period of safety.
How is a generic
• The development of medicinal products to be guided by the strict international regulations so. "Best Practices." When it comes to drug Good Manufacturing Practice (GMP), Good Laboratory Practice and Good Clinical Practice. This is a set of rules, with which compliance is ensured high quality of all processes. Company's ability to proceed in accordance with these processes is confirmed by certificates issued by state authorities.
• The first condition for successful development is to attract high-quality active substances. Quality requirements are high and continue to sharpen the. Are allowed only traces of impurities and their maximum concentration is dependent on the dose administered.
• Custom development of pharmaceutical products is becoming a significant part of the research and development process.
• The next step is to develop an appropriate pharmaceutical form, which would make the medicine to the human body in adequate concentration at the right time. In parallel with research into pharmaceutical drug form of passing the test of analytical methods for quality control.
• Pharmaceutical drug forms are very severely tested, and must demonstrate a long-term stability even in extreme conditions of high temperature and humidity.
• Therapeutic equivalence between the original and the generic drug is shown in bioequivalence studies, comparing the duration and extent of drug absorption in the human body. Tests are conducted in clinical settings in healthy volunteers and are assessed by means of objective statistical methods.
• The materials obtained during the R & D is prepared registration dossier, which serves as the basis for the appropriate authorization by the National Institute for Drug Control.
• The whole process of research and development is complicated in terms of time and financial and lasts from 2 to 5 years.