Pharmaceutical Trade Research Articles

Important Factors in the Development of Biopharmaceutical Logistics Centers

Human life is at the center of the fourth industrial revolution in the pharmaceutical trade. One of the major factors driving the growth of pharmaceuticals is the rapid growth of biopharmaceuticals. The global biopharmaceutical market is showing steady growth, and the current share of 20% of the drug market is expected to expand to 70% within the next 20 years. The domestic biopharmaceutical market has also turned into a trade surplus due to an increase of exports in 2017. Currently, there are no studies on the establishment of biopharmaceutical distribution centers. Therefore, in this study, it was assumed that the factors needed for the establishment of existing logistics centers and biopharmaceutical logistics centers would differ. In this study, three factors were extracted from a fuzzy AHP analysis – facility, location, and cost. In addition, 11 detailed factors were indicated, and their importance depended on temperature management devices, convenience of transportation, and the establishment of a logistics information system. Thus, facilities are more important in biopharmaceutical logistics centers than general logistics center.

СОВЕРШЕНСТВОВАНИЕ И ОПТИМИЗАЦИЯ ТОВАРНОЙ ПОЛИТИКИ КАК СПОСОБ ПОВЫШЕНИЯ КОНКУРЕНТОСПОСОБНОСТИ АПТЕК

Gathering information is a key component of market research marketing. The search and analysis of marketing information is carried out through four auxiliary systems, namely, an internal reporting system, a system for collecting external current marketing information, a system of marketing research and analysis of marketing information. Based on the information received, marketing research of the drug market is carried out and the needs of the population for pharmaceutical products are studied. Among the many areas of marketing research on the activities of pharmacies, the study of the range of sold medical and pharmaceutical goods in order to determine ways to optimize it is of paramount importance. A prerequisite for marketing research is the study of drugs as a product, its main pharmacotherapeutic properties, indications for use, release forms and other merchandising characteristics. It is important to analyze the assessments of consumer properties and indicators of use for each name of medicinal products in the assortment of a pharmaceutical organization. This article provides approaches to the definition of the assortment policy of the enterprise, gives the classification of the assortment of the enterprise «Pharmacy of low prices». The groups of drugs are identified depending on their effect on the pharmacy income. Based on consumer preferences, the main positions of the assortment of pharmacies, which are needed by consumers of the city of Penza and the Penza region, have been determined. Along with determining the optimal assortment of the pharmacy and the number of drugs for each pharmaceutical group on sale, it is important to determine the optimal ratio of drugs for each pharmaceutical group. An algorithm for the formation of a new assortment of the Low-Price Pharmacy enterprise has been developed. Recommendations for improving the assortment policy of the «Low Price Pharmacy» enterprise are offered. The features of pharmaceutical marketing of the market of non-prescription and prescription drugs have been studied. Optimization of the product policy of pharmacy organizations, taking into account the distribution of drugs by pharmaceutical trade groups, will ensure the survival of small-scale retailers in a competitive environment.

Corrigendum to: Globalization of pharmaceutical trade and healthcare coverage of the Millennium Development Goals

Corrigendum to: Globalization of pharmaceutical trade and healthcare coverage of the Millennium Development Goals

Photochemical analysis and antibacterial activity Tylophora indica (Burm. F.) Merill

Tylophora indica is a threatened medicinal plant which belongs to the family Asclepiadaceae. T. indica is a medicinal woody climber it is commonly used to treat Asthma, demand for leaves of T. indica in the pharmaceutical trade due to its use as a remedy for diabetes and also as a tonic of the nerves and as a laxative other ailments. The present paper reports the phytochemical analysis, antibacterial and antioxidant activity of a threatened plant. Phytochemical studies were taken up and the presence of alkaloids, flavonoids, phenols, saponins, steroids, tannins and terpenoids was confirmed by qualitative analysis and antibacterial activity of extracts of different T. indica explants were performed against gram positive and gram negative bacteria by the disk diffusion method. The activities of the compounds were compared with standard strain for antibacterial properties of the imine base and its solvent extract evaluated and presenting in indicate that the compounds are active in exhibiting antibacterial role also carried out.

National security: health care, pandemic (COVID-­19) and the global trade in counterfeit pharmaceuticals (Part 1)

Ukraine’s healthcare system faces unprecedented national security challenges in the third wave of the COVID-19 pandemic. A particularly acute issue is countering counterfeit pharmaceuticals, preventing drug shortages, joining efforts of the authorities and national manufacturers of drugs and medicines. According to the UN in Ukraine more than 60% of the population lives below the poverty line. Timely response to these challenges and taking preventive measures will save lives, minimize the volume and consequences of the pandemic. The work provides an economic and legal analysis, trends, risks and threats to the national security of the state and health protection during a pandemic, in order to protect intellectual property rights, adequate coordination of actions at the national and international levels. Based on the analysis of studies by the OECD, the EU Intellectual Property Office (EUIPO) and Europol shows the impact of counterfeiting on business and the economy, the criminal landscape in the EU. The basics of the anti-counterfeiting management, measures to implement a standard anti-counterfeiting strategy are proposed.

National security: health care, pandemic (COVID-19) and the global trade in counterfeit pharmaceuticals (part 2)

Ukraine’s healthcare system faces unprecedented national security challenges in the third wave of the COVID-19 pandemic. A particularly acute issue is countering counterfeit pharmaceuticals, preventing drug shortages, joining efforts of the authorities and national manufacturers of drugs and medical supplies. According to the UN, more than 60 % of the population lives below the poverty line in Ukraine. Timely response to these challenges and taking preventive measures will save lives, minimize the volume and consequences of the pandemic. The paper provides an economic and legal analysis, trends, risks and threats to national security of the state and health protection during a pandemic, in order to protect intellectual property rights, adequate coordination of actions at the national and international levels. The impact of counterfeiting on the criminal landscape in the EU, and also business and economy, is shown based on the analysis of studies by the OECD, the EU Intellectual Property Office (EUIPO) and Europol. The foundations of anti-counterfeiting management, measures to implement a standard anti-counterfeiting strategy are proposed.

Фармацевтика України: від залежності до ендогенного розвитку

The article substantiates various theoretical and applied principles of developing high-tech pharmaceutical industries (HTPI). It is established that the key problem of developing countries in this area is the dependence on resources and markets of developed countries, while the involvement of advanced foreign technologies can be a catalyst for increasing the technological potential of host countries (subject to the availability of proper knowledge and human capital, changes in the institutional environment, and improved the framework conditions for innovation). In the context of the development of HTPI, the author shows the importance of the network nature of the acquisition by pharmaceutical companies of sustainable competitive advantages based on resources that are difficult to simulate or replace. It is substantiated that networks built with local research institutions, higher education institutions, and research units of other companies, give pharmaceutical manufacturers the opportunity to access complementary assets and become their specific resource, which provides unique competitive advantages. The author reveals various methodological and statistical features of the categorization of industries by the level of technology in the conditions of globalization. It is substantiated that the current low value of the ratio of research and development (R&D) to value-added generated by pharmaceuticals of individual countries is not a sign of the industry’s low technological level, as the current revenues are the result of long-term R&D and harmonization procedures for launching new drugs with lags of 10-15 years. A new tool for the study of international trade in high-tech pharmaceuticals is proposed, whose peculiar feature consists in the categorization of nomenclature items by end use; the List of high-tech medical and pharmaceutical intermediate goods is formulated (in accordance with SITC Rev.4 and UKT FEA); the following indicators are proposed: the coefficient of import dependence of pharmaceutical production, the coefficient of "purified" exports of pharmaceutical products and the coefficient of imports coverage with HTPI output, and the formulas for their calculation are provided. The author's approach is the first to create the opportunity to assess the scale of costs and the dependence of the pharmaceutical industry on imported components that embody advanced technologies and are the industrial supplies for HTPI. It was found that in Ukraine the share of foreign intermediate high-tech goods in the consumption of the industry reaches 82.2%; the industry, working on imported substances, produces mainly products for the domestic market, without earning foreign currency, even to cover the cost of purchasing the necessary ingredients; manufacturers do not rely on synthesized chemical products of domestic production, primarily due to the fact that the products of the chemical industry for the needs of pharmaceuticals in Ukraine are virtually non-existent; and the increase in output depends on foreign technologies and intermediate goods. It is substantiated that Ukraine’s pharmaceutical industry is critically dependent on imported supplies to ensure the smooth operation of enterprises and the healthcare industry. Key endogenous barriers that hinder the development of HTPI have been identified, including problems in the training of specialists and a lack of scientists whose competencies would contribute to solving the problems of endogenous development of the industry; lack of state aid to business entities for research, and technological and innovative activities; lack of own funds to increase expenditures on R&D and implementation of large-scale investment and innovation projects; and lack of cheap loans, due to which Ukrainian pharmaceutical manufacturers find themselves in unequal conditions compared to foreign competitors. Conceptual bases of HTPI development in Ukraine are proposed; justified the expediency of legal changes, definition of strategic priorities and introduction of measures of development of HTPI in Ukraine based on the comprehensive approach, which will cover creation and development of pharmaceutical ingredients for medicines (chemical and biotechnological goods), medical products, fillers, packing materials, machinery and equipment for pharmaceuticals to help reduce the dependence on foreign technologies, and to increase the level of production localization, employment and revenues to the budgets of all levels.

Ukraine's pharmaceuticals: from dependence to endogenous development

The article substantiates various theoretical and applied principles of developing high-tech pharmaceutical industries (HTPI). It is established that the key problem of developing countries in this area is the dependence on resources and markets of developed countries, while the involvement of advanced foreign technologies can be a catalyst for increasing the technological potential of host countries (subject to the availability of proper knowledge and human capital, changes in the institutional environment, and improved the framework conditions for innovation). In the context of the development of HTPI, the author shows the importance of the network nature of the acquisition by pharmaceutical companies of sustainable competitive advantages based on resources that are difficult to simulate or replace. It is substantiated that networks built with local research institutions, higher education institutions, and research units of other companies, give pharmaceutical manufacturers the opportunity to access complementary assets and become their specific resource, which provides unique competitive advantages. The author reveals various methodological and statistical features of the categorization of industries by the level of technology in the conditions of globalization. It is substantiated that the current low value of the ratio of research and development (R&D) to value-added generated by pharmaceuticals of individual countries is not a sign of the industry’s low technological level, as the current revenues are the result of long-term R&D and harmonization procedures for launching new drugs with lags of 10-15 years. A new tool for the study of international trade in high-tech pharmaceuticals is proposed, whose peculiar feature consists in the categorization of nomenclature items by end use; the List of high-tech medical and pharmaceutical intermediate goods is formulated (in accordance with SITC Rev.4 and UKT FEA); the following indicators are proposed: the coefficient of import dependence of pharmaceutical production, the coefficient of "purified" exports of pharmaceutical products and the coefficient of imports coverage with HTPI output, and the formulas for their calculation are provided. The author's approach is the first to create the opportunity to assess the scale of costs and the dependence of the pharmaceutical industry on imported components that embody advanced technologies and are the industrial supplies for HTPI. It was found that in Ukraine the share of foreign intermediate high-tech goods in the consumption of the industry reaches 82.2%; the industry, working on imported substances, produces mainly products for the domestic market, without earning foreign currency, even to cover the cost of purchasing the necessary ingredients; manufacturers do not rely on synthesized chemical products of domestic production, primarily due to the fact that the products of the chemical industry for the needs of pharmaceuticals in Ukraine are virtually non-existent; and the increase in output depends on foreign technologies and intermediate goods. It is substantiated that Ukraine’s pharmaceutical industry is critically dependent on imported supplies to ensure the smooth operation of enterprises and the healthcare industry. Key endogenous barriers that hinder the development of HTPI have been identified, including problems in the training of specialists and a lack of scientists whose competencies would contribute to solving the problems of endogenous development of the industry; lack of state aid to business entities for research, and technological and innovative activities; lack of own funds to increase expenditures on R&D and implementation of large-scale investment and innovation projects; and lack of cheap loans, due to which Ukrainian pharmaceutical manufacturers find themselves in unequal conditions compared to foreign competitors. Conceptual bases of HTPI development in Ukraine are proposed; justified the expediency of legal changes, definition of strategic priorities and introduction of measures of development of HTPI in Ukraine based on the comprehensive approach, which will cover creation and development of pharmaceutical ingredients for medicines (chemical and biotechnological goods), medical products, fillers, packing materials, machinery and equipment for pharmaceuticals to help reduce the dependence on foreign technologies, and to increase the level of production localization, employment and revenues to the budgets of all levels.

M3DISEEN: A novel machine learning approach for predicting the 3D printability of medicines.

Artificial intelligence (AI) has the potential to reshape pharmaceutical formulation development through its ability to analyze and continuously monitor large datasets. Fused deposition modeling (FDM) three-dimensional printing (3DP) has made significant advancements in the field of oral drug delivery with personalized drug-loaded formulations being designed, developed and dispensed for the needs of the patient. The FDM 3DP process begins with the production of drug-loaded filaments by hot melt extrusion (HME), followed by the printing of a drug product using a FDM 3D printer. However, the optimization of the fabrication parameters is a time-consuming, empirical trial approach, requiring expert knowledge. Here, M3DISEEN, a web-based pharmaceutical software, was developed to accelerate FDM 3D printing using AI machine learning techniques (MLTs). In total, 614 drug-loaded formulations were designed from a comprehensive list of 145 different pharmaceutical excipients, 3D printed and assessed in-house. To build the predictive tool, a dataset was constructed and models were trained and tested at a ratio of 75:25. Significantly, the AI models predicted key fabrication parameters with accuracies of 76% and 67% for the printability and the filament characteristics, respectively. Furthermore, the AI models predicted the HME and FDM processing temperatures with a mean absolute error of 8.9°C and 8.3°C, respectively. Strikingly, the AI models achieved high levels of accuracy by solely inputting the pharmaceutical excipient trade names. Therefore, AI provides an effective holistic modeling technology and software to streamline and advance 3DP as a significant technology within drug development. M3DISEEN is available at (http://m3diseen.com/predictions/).

Pharmaceutical trade marks: an evaluation of regulatory intricacies and challenges

Pharmaceutical trade marks: an evaluation of regulatory intricacies and challenges Kuhu Tiwari, Kuhu Tiwari Search for other works by this author on: Oxford Academic Google Scholar Niharika Sahoo Bhattacharya Niharika Sahoo Bhattacharya Email: niharika@rgsoipl.iitkgp.ac.in Search for other works by this author on: Oxford Academic Google Scholar Journal of Intellectual Property Law & Practice, Volume 15, Issue 9, September 2020, Pages 738–748, https://doi.org/10.1093/jiplp/jpaa110 Published: 31 August 2020 Article history Received: 21 August 2019 Revision received: 12 April 2020 Accepted: 19 June 2020 Published: 31 August 2020

A Life of “Continuous and Honourable Usefulness:” Chemical Consulting and the Career of Robert Warington (1807-1867)

Robert Warington (1807-1867) was a central figure in the mid-nineteenth century chemical community, notably through his role in the foundation of the Chemical Society of London in 1841. As demand for chemical services grew, Warington constructed an ultimately lucrative career in chemistry in which consulting played a major part. His formative years laid ideal foundations for establishing himself as a consultant, whilst his appointment as chemical operator to the Society of Apothecaries’ pharmaceutical trade provided the status and infrastructure to sustain this activity. Here I explore the nature of the chemical services he performed for a range of customers through a survey of his experimental notes. At a time when professional boundaries in the subject were being delineated, this case study provides an example of how chemistry could be commercialised outside the academic environment and how consulting merged into a broader scientific career.

Perdagangan Bebas Produk Farmasi dan Alat Kesehatan serta Kesiapan Memenuhi Persyaratan Cetak Biru Masyarakat Ekonomi ASEAN

The implementation of the ASEAN Economic Community (AEC) as an Indonesian Government’s strategic step has an impact on economic globalization. The study on pharmaceutical products and medical devices free trade was done using qualitative and quantitative methods. The data were collected from a round table discussion about "Free Trade in Health Goods and Services in ASEAN" which involved the Ministry of Health (MoH), Ministry of Trade (MoT), and National Agency for Drug and Food Control (NADFC). The discussion aimed to obtain information on the readiness to meet the AEC blueprint. Secondary data on export and import of pharmaceutical products and medical devices were obtained from the MoT. The results of the study show that between 2013 and 2017 there were 70-72 product items exported to 9 ASEAN countries with a value much greater than the import. The tariff measure (TM) requirements included the Most Favored Nation (MFN) assessment and regulation of the trade remedy procedure by MoH and MoT. The implementation of ASEAN Common Technical Dossier (ACTD) and Good Manufacturing Practice inspection agreements, Bioequivalence reporting agreements, agreements related to traditional medicines and health supplement have been done by NADFC and industry. The simplification of Certificate of Origin, operation certification procedures and realization of ASEAN self-certification have to be specified. MoH must coordinate with NADFC and MoT in deciding and implementing regulations

Do Free Trade Agreements Matter to Drug Lag? Recent Evidence From Korea After the Korea-U.S. Free Trade Agreement.

The KORUS FTA includes various clauses on marketing approval of new medicines and their reimbursement decisions. We aim to capture the availability of new medicines, to measure drug lags for new medicines, and to demonstrate the effect of the KORUS FTA on the timely availability of new medicines in the Korean market. We selected new drug applications approved in the United States between 2007 and 2015, calculated the drug lag, which was defined as the time difference between the date of regulatory approval in the United States and in Korea, and constructed a logistic and Cox model to capture the effect of the variables of interest on the availability and drug lag of new medicines in the Korean market. The FDA in the United States approved 160 NDAs between 2007 and 2015. The KORUS FTA does not increase the availability of new medicines or shorten the drug lag of new medicines. However, the presence of the manufacturer in Korea was significantly related to the availability and drug lag in the Korean market. It is noteworthy that the presence of the manufacturer, which is a kind of by-product of free trade in pharmaceuticals, affected drug lag.

Intellectual Property Exhaustion and Parallel Imports of Pharmaceuticals: A Comparative and Critical Review

This Chapter addresses the topic of intellectual property (IP) exhaustion in the context of the parallel trade of pharmaceuticals. These imports, which are controversial in general, are more complex with respect to pharmaceuticals, which require additional marketing and import authorizations. Nevertheless, individual countries remain free to accept these imports under the flexibility of Article 6 of the Agreement on Trade Related Aspect to Intellectual Property Rights (TRIPS Agreement). This Chapter reviews several national approaches—in developed, developing, and least developed countries (LDCs)—from the perspective of the exhaustion of patent rights as well as other IP rights. Through this review, it highlights that several countries today accept parallel trade. A large of number of these countries are, however, developed countries, whereas several developing countries and LDCs instead prohibits parallel imports. This finding is perplexing, and the reasons for this restrictive approach are unclear as developing countries and LDCs need flexible policies and can largely benefit from parallel trade. In addition, despite the claim by the pharmaceutical industry that parallel trade would increase the price of medicines in these countries—as originator would increase prices due to the fear of parallel imports—medicines are sold at lower prices mostly because of governments’ pricing or after the expiration of patent protection. Based on this review, this Chapter concludes that national legislations, which are not taking advantage of the flexibility in Article 6 of the TRIPS Agreement, may consider reviewing their policies and allow parallel imports.

Impact of Cross-border Mergers and Acquisitions on the Development of Chinese Pharmaceutical Exports and Imports

The article is devoted to the research into the impact of cross-border mergers and acquisitions, conducted by international pharmaceutical companies in China, on Chinese participation in international pharmaceutical trade. Relevance of the study resides in the importance of mergers and acquisitions as instruments that are widely used in a foreign markets penetration process and that lead to the enhancement of intercorporate trade, thus significantly influencing country’s foreign trade. International pharmaceutical companies expanded their operations in Chinese market during the last two decades as a result of the market liberalization. Mergers and acquisitions, conducted by international players, have directly or indirectly led to higher growth rates of Chinese foreign trade in pharmaceutical products, to geographic diversification of pharmaceutical exports and to an increase in deliveries from developed countries. China more than doubled its share in global exports of pharmaceutical products and almost quadrupled its share as an importer of pharmaceuticals. The specific features of Chinese pharmaceutical trade are high growth rates in imports and imports’ significant excess over exports. Substantial proportion of Chinese imports is constituent by pharmaceutical components, that are needed to ensure production of high quality pharmaceuticals in China. Mergers and acquisitions play important role in this process and cause changes in geographical structure of imports. Seven biggest suppling countries, which hold more than two thirds of imports to China, represent the countries of origin of companies that are actively involved into mergers and acquisitions in Chinese pharmaceutical market. The research results can be used by public regulatory authorities for the elaboration of industrial development policies through stimulating or deterring foreign direct investments. Research can be of use to pharmaceutical companies in formulating competition strategies for domestic and foreign markets.

Globalization of pharmaceutical trade and healthcare coverage of the Millennium Development Goals

Globalization of pharmaceutical trade and healthcare coverage of the Millennium Development Goals

Organoleptic excipients used in pediatric antibiotics

Taste is a crucial factor that determines the palatability of the oral dosage form and patient compliance. ObjectiveThe aim of this work was to evaluate the organoleptic excipients in oral antibiotics for pediatric use marketed in Brazil. MethodsThe information was obtained from the GuidetoPharmacy, a reference for the pharmaceutical trade. The analysis included dosage forms for oral administration and drugs and their combination with antibacterial action. After this survey, we identified the constitution of the flavoring, sweetening, and coloring agents of each medicine. The results are presented in a descriptive form. ResultsTwelve drugs or associations are distributed in 70medicines. Oral suspension was the most common pharmaceutical dosage form. Sweeteners were sucrose, sodium saccharin, and sodium cyclamate. All the coloring agents observed are synthetic and the most frequent ones were yellow twilight no. 6, yellow tartrazine no. 5, and red ponceau 4R. The presence of two or more types of flavorings per medicine was observed. ConclusionAntibacterials use coloring agents, flavorings, and sweeteners to facilitate the administration of medicines for children, using up to six different substances per formulation. No natural coloring agent was observed, demonstrating an issue to be explored in the future. It is important to note that, although necessary, these excipients are responsible for a high incidence of allergic reactions in children.

Analysis of Issues and Future Trends Impacting Drug Safety in South Korea.

New drug safety issues are emerging that are beyond the existing medication safety management system. To pre-empt these problems, forecasting future drug safety trends and issues is a necessity. The objective of this study was to identify issues and future trends impacting drug safety using foresight methodologies. The study started by identifying global megatrends, trends in safety management of medicines, and key issues in drug safety. A total of 25 global megatrends were selected by extracting and clustering keywords from 26 reports concerning the future. Using the text-mining method, 10 trends in drug safety were identified from 3593 news articles. This study derived 60 issues which can arise from the trends, and finally, the 20 key issues with the highest urgency and impact scores were selected. Some examples of issues with high scores were as follows: illegal distribution of medicines, lack of technology for managing and utilizing big data, change in the pharmaceutical trade environment, lack of education and safety management for specific populations, lack of artificial intelligence-based technology for the safety management of medicines, and the prevalence of drug advertisements through social network services. The key issues could be used to establish plans for medication safety management.

Country-Specific Determinants of Intra-Industry Trade in Pharmaceuticals: The Case of Poland and Its European Union Partners

Trade cooperation between European Union countries is based mainly on intra-industry trade, consisting in the simultaneous import and export of similar products belonging to the same industry (commodity group). The present study has investigated the country-specifi c determinants of intra-industry trade between Poland and its European Union trading partners in pharmaceutical products during the time period 2004-2016. To this end, an econometric model for panel data was constructed. The research shows that the intensity of intra-industry trade in Poland-EU trade in pharmaceuticals is determined by several key factors. The intensity of trade with particular EU countries and the size of general government expenditure on health in the countries of trading partners have a positive impact on the development of this type of exchange. A factor that signifi cantly and simultaneously affects the intensity of intra-industry trade is the degree of imbalance in the trade balance in pharmaceutical products with individual trading partners. The development of intra-industry trade is also limited by factors related to the level of economic development of trading partners. The study confi rmed that the greater the differences in the level of GDP per capita between Poland and the trading partner, the less intense intra-industry trade. Also, the growth of GDP per capita in the countries of trade partners is not conducive to the development of intra-industry trade in Poland’s trade in pharmaceuticals. The direction of the impact of this variable (GDP per capita) on the intensity of two-way trade obtained in this study does not confi rm the predictions of the theory of intra-industry trade. However, the negative impact of this factor can be explained by the specifi city of pharmaceutical products that are purchased by consumers generally only in justifi ed situations resulting from health or life protection.

Industrial perceptions of medicines regulatory harmonization in the East African Community.

BackgroundMedicines regulatory harmonization has been recommended as one way to improve access to quality-assured medicines in low- and middle-income countries. The rationale is that by lowering barriers to entry more manufacturers will be enticed to enter the market, while the capacity at the national medicines regulatory authorities is strengthened. The African Medicines Regulatory Harmonization Initiative, agreed in 2009, is developing regional platforms with harmonized regulatory procedures for the registration of medicines. The first region to implement medicines regulatory harmonization was the East African Community (EAC). The harmonization was based on the existing EAC Free Trade Agreement, which officially launched the free movement of goods and services in 2010.Methods and findingsIn this study we conducted semi-structured interviews and performed document reviews. The main target group for our interviews was pharmaceutical companies. We interviewed 18 companies, including 64% of the total companies who had experienced the EAC joint product assessment procedure, and two EAC-based national medicines regulatory authorities. We found that generally pharmaceutical companies are supportive of the African-based MRH efforts and appreciative of the progress being achieved. However, many companies are now hesitant to use the joint product assessment procedure until efficiency improvements are made. Common frustrations were the length of time to receive the actual marketing authorization; unexpectedly higher quality standards than national procedures; and challenges in getting all EAC countries to recognize EAC approvals. Smaller, less attractive markets have not yet become more attractive from a corporate perspective, and there is no free trade of pharmaceuticals in the EAC region.ConclusionsPharmaceutical companies agree that medicines regulatory harmonization is the way forward. However, regulatory medicines harmonization must actually result in quicker access to the harmonized markets for quality-assured medicines. At this time, improvements are required to the current EAC processes to meet the vision of harmonization.