Comparison of a global submission of new biological entity and a new chemical entity

Abstract

The world covers more than 190 countries in which at the moment in most of them pharmaceutical legislations and regulatory requirements are established and implemented, e.g. to describe the marketing authorization (MA) procedure for medicinal products.<br /> To be able to submit a marketing authorization application (MAA) in all these countries, it is important to know exactly the pharmaceutical legislations (regulations, directives and guidelines) and the regulatory requirements in each of the country in advance.<br /> The objective of the pharmaceutical companies is to identify ways and factors that impede the efficient registration of new medicinal products and their timely access to patients. Due to the fact that the European Union (EU) and the United States (US) are the biggest and most potential markets for medicinal products in the world, global working companies focus and analyze the EU and US pharmaceutical legislations and regulatory requirements very detailed in advance and include these requirements from EU and US normally in their development concept of a new medicinal product and consequently in their global regulatory strategy for MAA of this product. But the industry recognized in the last few years also that the other regions of the world – Japan (JP), Latin America (LA), Middle East (ME)/Africa (AFR) and South East Asia (SEA), and are becoming increasingly important to pharmaceutical companies in their global marketing strategies. Therefore companies with global approach realize that it is not sufficient anymore to develop their global regulatory strategy based on the regulatory requirements in EU and US but also to take into consideration the other regions of the world.<br /> Based on this knowledge the different pharmaceutical legislations and regulatory requirements for a new MAA of an NBE and NCE on the examples of EU, US, Croatia (as one country of Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries (CADREAC)), Brazil, Singapore (as one country of the Association of South-East Asian Nations (ASEAN)) and China are discussed and analyzed in detail.<br /> Afterwards the comparison between the different pharmaceutical and regulatory legislations in these countries and the comparison between MAAs for NBEs and NCEs follows.<br /> Based on this comparison the general aspects of a global development for a new compound (NBE or NCE) are discussed. The differences in global development between an NBE and an NCE are also covered within this dissertation. Based on this general strategy for global development of new compounds a global regulatory strategy for an NBE on the example of a mAb is developed.<br /> As the pharmaceutical legislations and requirements are permanently changing it is of utmost importance that pharmaceutical companies check the current legislations and requirements before starting a global development of a new compound. Also during the development of a new compound the changes in pharmaceutical legislations and regulations have to be checked and have to be incorporated in the global strategy in order to submit a MA dossier according to current requirements. This will ensure that the authorities accept the MA because of following regulations or guidelines. In case a regulation or guideline is not followed the applicant has to be present a justification for doing this approach and it cannot be guaranteed that authorities will accept this. Therefore it is strongly recommended to check the requirements and fulfill all requirements to be able to get an approval for the MA dossier of the newly developed compound.<br /> The requirements to get a medicinal product approved and reimbursed increase constantly and it can be anticipated that they will increase further.<br /> One possible solution to deal with the increased costs for development and the increasing requirements might be that pharmaceutical companies will merge and will develop new innovative medicinal products together and share the development costs. This will be especially attractive for small and medium-sized companies. Also companies might think about the location of their development centers in order optimize the development. It is recommended that companies will have only one or two global development centers where the global development for all new compounds is done.<br /> Pharmaceutical companies should be in closed contact with authorities in order to be able to fulfill all requirements needed to get a new medicinal product approved and marketed. Companies should be also in close contacts with governments especially regarding health care systems in order to fulfill their requirements and in order to be able to influence them with regard to decisions on health care systems. Besides all increasing barriers for getting new products approved and marketed, it is of utmost importance that the development of new innovative medicinal products will be continued to offer patients best medicinal supply.<br /> Therefore it seems to be logical that pharmaceutical companies, authorities and governments have to work together and find solutions that the development of new innovative drugs will be attractive and efficient for all sites in future.