A Comparative Study Of The Major Administrative Regulations On Pharmaceuticals In China And Russia

Pharmaceutical administration regulations are those in connection with pharmaceutical supervision and administration and are intended for a country to strengthen pharmaceutical supervision and administration,guarantee pharmaceutical quality and medication safety,and keep the health of people and their legal rights and interests of medication.Globally,pharmaceutical administration laws are the fundamentals that institutions and individuals that work on pharmaceutical research and development,production,operation,use and supervision and ministration shall follow.Not only are pharmaceutical administration laws associated with patient treatment,medication safety,the people's health and authorities of medical staff,as well as the interests of pharmaceutical manufacturing and sales enterprises and the pharmaceutical development organizations,but they also have direct impact on social stability due to the public health issues resulted from the effects of drugs in treating various diseases.Economic benefit that is generated from pharmaceutical manufacturing and sales is also closely related to the economic development of a country or region,serves as an important part of national economy and the system for social protection in health,reflects the structure and social medical security coverage,the construction and reform of economic management and supervision mechanism,and exerts an important influence on legal system construction and social development of a country.BackgroundOver the past few years,Russia has been playing a crucial part in the "the belt and road" initiative which involves a number of regions across the Eurasia-from the Eastern Asia Pacific Economic Circle to the Western European Economic Circle.As a result,studying primary pharmaceutical regulations of a large nation,like Russia,not only provides a good reference for the development and improvement of China's legal system and social security system but also offers important legal support to Chinese pharmaceutical manufacturers,whether they are specialized in Chinese or western medical products,to facilitate their competitiveness in the international pharmaceutical market,by which it is supposed to promote the internationalization of China's pharmaceutical industry and,ultimately,to promote the coordinated development between our economy and society.ContentThis thesis consists of six sections that focus primarily on the development,major structure and features of the regulations on the circulation of pharmaceuticals of Russian Federation and comparison between The Drug Administration Law of the People's Republic of China,Enforcement Regulation of the Law of Drug Administration of the People's Republic of China and Drug Circulation Law of the Russian Federation.In consideration of the traditional pharmaceutical development of Russia and difficulties and problems confronting traditional Chinese medicinal products concerning with respect to market access to Russia,this thesis also probes the stipulations and requirements for traditional medicinal products stipulated in Russian food and drugs and regulations by emphatically analyzing the regulations on traditional medicine specified by the technical rules for Food Safety made by Russian Customs Union,based on which the matters that need attention when Chinese medicines and healthcare products are introduced to Russian market.At the end of this thesis,suggestions for China's pharmaceutical administration laws to be perfected and for further expanding the market share of traditional Chinese medicinal products in Russia are put forward based on comparative study on pharmaceutical(including food)regulations in China and Russia.Section one summarizes the background,significance,major content and research methods of this study.Pharmaceutical administration regulations are the fundamentals that organization and individuals that work on pharmaceutical research and development,production,operation,use and supervision and ministration shall observe.Public healthcare issues that come along with the effects of medicine in treating various diseases can have direct impact on social stability;while the economic benefit generated from pharmaceutical manufacturing and sales is closely linked to the economic development of a country or region.As a result,countries all over the world have paid extensive attention to the formulation of laws and regulations concerning pharmaceutical administration and continuously perfected them based on the demands of their own pharmaceutical market with social and economic development as well as scientific improvement over the past century.Comparison between pharmaceutical and healthcare regulations and laws of China and those of Russia,especially those in connection with traditional medicine,will not only provide legal support for Sino-Russia cooperation in traditional medicine and,particularly,Chinese pharmaceutical enterprises that manufacture Chinese and western medicine when they compete in international pharmaceutical market,but also further consolidate Sino-Russia strategic partnership and promote internationalization of Chinese pharmaceutical industry.Section two elaborates the development history of pharmaceutical regulations and laws in both countries,as well as the characteristics of their structural systems,emphatically analyzes the differences between Chinese and Russian major pharmaceutical administration regulations based on Drug Circulation Law of the Russian Federation and The Drug Administration Law of the People's Republic of China,followed by comparative analysis of 12 aspects with respect to current drug regulatory systems of both countries and pharmaceutical market,wholesale,storage,sales,marks and reinforcement of regulations and laws stipulated in the aforementioned two laws,systematic analysis of the major pharmaceutical administration regulations in China and Russia,expound the implications of the principals of these two laws,as well as their guiding significance for the development of medical and healthcare undertakings.In section three,development situation traditional Russian medicine and stipulations n and requirements for Russia's pharmaceutical(food)administration laws and regulations are introduced.Traditional therapeutic methods in Russia can be divided into therapeutic methods with local traditional medicine and those with foreign traditional medicine.As Russia turns to an all-round market economy,pills made from Russian local herbs have been allowed to be sold in drug stores after registration and approval.For imported pharmaceutical products,however,Russia has implemented a strict medical license system,which means traditional Chinese medicinal products are not access to Russia's medical market unless they imported by legal means with licenses issued after going through registration and declaration procedures.This section presents the definitions of terms concerning traditional medicine stipulated by Russia pharmaceutical regulations and laws,as well as stipulations and requirements for national registration of traditional medicinal products and food.Comparative study on the content involving traditional medicine in the technical rules for Food Safety made by Russian Customs Union and that stipulated in Chinese Medicine Law and Food Safety Law of the People's Republic of China is conducted in section four.Definition concerning traditional medicinal product stipulated by the technical rules for Food Safety made by Russian Customs Union includes:bioactivity additive,food for healthcare and treatment purposes,food for preventive dietary uses,special food and tonic drink,etc.Traditional medicinal products imported to Russian market shall conform to the standards set forth in every chapter of the technical rules for Food Safety made by Russian Customs Union.This usually involves in national registration for special food that is handled by the authorized agencies located in the member states of Customs Union;there is no fixed term for such registration.Technical rules for Food Safety made by Russian Customs Union have provided an approach for traditional Chinese medicinal products and healthcare products to access to Russia in a lawful manner.In section five,SWOT is used to make comparative analysis of the advantages and disadvantage,opportunities and challenges of the development of Russia's traditional medicine,followed by current situation of Russia's pharmaceutical market,the impact of Russian market on the market access to the CIS(Commonwealth of Independent States)and European markets of Chinese medicinal products,and analysis of difficulties and challenges currently facing Chinese medicinal products'export and access to Russian market.Constructive suggestions for China's pharmaceutical administration regulations to be perfected and for further expanding the market share of traditional Chinese medicinal products in Russia are put forward based on comparative analysis of pharmaceutical(including food)regulations in China and Russia in combination with the historical background of China's "Belt and Road" initiative.In section six,where the conclusion of this thesis is made especially on the differences of Drug Administration Law between China and Russia,which includes the drug release,drug information and drug labeling of import and export in Chinese Drug Administration Law.It is suggested that the Chinese pharmaceutical enterprises must understand and fully prepare the information when they are preparing for drug registration and clinical trials in Russia.Suggestions are made on the protection of the legal and policy guarantee,the establishment of special management institutions,the enhancement of educational research and publicity,the strengthening of inter departmental cooperation and the formulation of industry standards and other related policies.In particular,constructive suggestions were made on the approach for Traditional Chinese Medicine(TCM)entering Russian market.MethodIn this thesis,for the first time in history,systematic analysis of the content of Russia's primary pharmaceutical administration regulations is conduced based on considerable translation,collation,summary and comparative analysis of those regulations,based on which the legal framework of pharmaceutical administration applied by Russian government is revealed.Also for the first time ever,comparative analysis of the differences between Russia's and China's pharmaceutical administration regulations is conducted,followed by a probe into their structural systems,characteristics of basic content and referential experiences.Matters that need attention for Chinese medicinal products to access to Russia's pharmaceutical market are analyzed based on the situation of Russia's pharmaceutical administration regulations.Norms and requirements for access of Chinese medicinal products to Russian market are explored according to the regulations on traditional medicinal products stipulated by Russia's pharmaceutical administration regulations and the technical rules for Food Safety made by Russian Customs Union.ConclusionAfter enormous translation,conclusion,comparative analysis,and system analysis on the contents of Russian regulations,for the first time,this article systematically analyzed main contents of the Russian pharmaceutical administration,clarified the legal framework of the government management of pharmaceutics;for the first we analyzed and compared the differences of regulations of pharmaceutical administration between China and Russia,and discussed its formation system,basic content for reference.Based on the current situation of Russian pharmaceutical administration regulations,we analyzed the issues we might face when Chinese medicine products entering the Russian pharmaceutical market.According to the regulations of Russian pharmaceutical administration,on traditional pharmaceutical products,this article analyzed ad discussed the requirements for Chinese medicine products entering Russian market.Due to different national conditions,there are some differences in regulations of pharmaceutical administration between China and Russia.We can investigate the regulations of pharmaceutical administration in Russia so as to better our own system in Chinese pharmaceutical management regulations and improve the social security system construction.To investigate on Russian pharmaceutical regulations can provide important legal support for Chinese and western medicine production enterprises to participate in the international pharmaceutical market competition,promote Chinese pharmaceutical industry internationalization development,broaden the China-Russia economic and trade exchange channels in medicine so as to further promote the coordinated development of China's economy and society.Chinese medical products,especially Chinese medical patent and Chinese traditional medicine health care products must in accordance with the relevant laws and regulations of Russia in order to enter into the Russian market.As the political,economic and trade exchanges have become increasingly close today,understanding of the main drug regulations in Russia not only conforms to China-Russia national interests,but also meet the health needs of the Russian people.It is conducive to pragmatic cooperation and strategic partnership established by the leaders of our two countries.