Joining WTO will give a new momentum to the development of Ukraine’s pharmaceutical market. As a WTO member Ukraine will have access to highly efficient drugs and services provided by the leading pharmaceutical companies as well as modern technologies to meet the growing demand for pharmaceutical services. The latter include physician-pharmacist cooperation, a wider introduction of prescription-only drugs, a convenient patient information database and much more. However, the industry may have to face the fact that the majority of the Ukrainian companies will not be able to meet the WTO membership requirements. They will have to look for extra resources and make adequate decisions fast. It is essential that as much as possible is done to meet the challenge before Ukraine joins the WTO. Let us see what exactly may have an adverse effect on the pharmaceutical business in Ukraine.  Compliance with the international quality standards, including the GMP standards for pharmaceutical businesses, is one of the main requirements for WTO membership. In Canada and USA any company engaged in the fabrication, packaging, labelling, distribution, testing, wholesaling of drugs and export of drug products must hold an establishment license. The establishment license is issued only if documentary proof has been provided of compliance with the GMP requirements for all divisions of a pharmaceutical company. After Ukraine joins the WTO foreign pharmaceutical companies with GMP licenses and fully adequate quality control systems will enter the Ukrainian market.  Thus, on the Ukrainian market there will be companies that meet the GMP requirements and companies that do not. At the present time Ukrainian companies are not required to have a GMP license, but in the future this may be a serious problem as far as staying on the market is concerned. Companies that ship, store, test and develop drug products also will be affected. The majority of Ukrainian pharmaceutical companies are oriented toward the domestic market and their products are inferior to those of foreign companies.  The quality control system used by most Ukrainian pharmaceutical companies does not meet the modern requirements and cannot compete with Western corporations. When the leading pharmaceutical companies of the world enter the Ukrainian market the competition will be stiff and the legitimacy of the weak domestic quality control systems will be questioned. The pharmaceutical companies failing to meet the GMP requirements may find themselves under severe pressure. It is well known that during the transition to the national and international market merger the Eastern European countries and the Baltic countries had lost the government control over whole industries. Ukraine joining the WTO may lead to the destabilization of the pharmaceutical industry - the leader of the national economy. It has already been stated that Ukraine produces a variety of generic drugs. The companies create numerous copies and compete among themselves on the domestic market. The protection of intellectual property is part of the policy that is mandatory for all WTO candidates and Ukraine cannot hope to be an exception. If a drug is not licensed its sale is on the domestic market is illegal. The development of new drugs involves considerable research expenses to which the cost of clinical trials is added and that will increase manifold in order to meet the modern requirements. There is a fairly common belief that the Ukrainian manufacturers will gain an access to the leading world markets with their drugs made in accordance with the GMP standards. It is true that the leading Ukrainian pharmaceutical companies have sufficient potential to promote their products, but, for a number of objective reasons, they are not represented on the markets of Europe, Canada and the USA. This is largely due not to trade barriers but to the lack of the state-of-the-art quality control system. The latter implies both compliance with the GMP standards and a quality assurance system with appropriate staff, a system of change control, self-inspection and validation, as well as established production, testing, storage, distribution and sales procedures. These requirements must be met not only by drug manufacturers but also by those engaged in drug development – research centres, laboratories, pilot plants and product introduction divisions. Pre-approval inspection (PAI) Compliance Program 7346.832 for new drug evaluation requires that all batches made for clinical trials are checked for compliance with the CGMP, including audit data, such as basic clinical data, bioavailability, bioequivalency and stability. Besides, the review and evaluation of records and data submitted in an application are to be reviewed and evaluated, including the components, composition, batch instructions, in-process, and finished product test points and specifications established for the resulting drug product. Apart from the above the Ukrainian companies are at a disadvantage compared to Western companies due to weaker investment climate, legal protection for the domestic manufacturer and taxation and customs legislation. There is no effective legislative support for making adequate decisions in a prompt manner to ensure the stability of the operation of the Ukrainian companies after joining the WTO. At the present time it is necessary to assess all possible risks that may lead to a drop in production so that negative consequences may be minimized. It is vitally important that the state provides support to the domestic manufacturers and controls the situation in the pharmaceutical industry after Ukraine joins the WTO.