Pharmaceutical Enterprises Research Articles

PaedVacCOVID - safety of the BNT162b2 vaccine against the SARS-CoV-2 in children with and without comorbidities aged 5 to 11 years.

Little is known about specific safety aspects in children with significant comorbidities receiving the mRNA vaccine BNT162b2, as approval studies did not address this population. This study's purpose is to evaluate safety and adverse events in these children compared to healthy children. In this prospective, multicentre, industry-independent cohort study, caregivers whose children received BNT162b2 were asked to participate in an online questionnaire. Potential side effects were evaluated in ten organ related categories. Frequency of symptoms was compared in both cohorts by bivariate analysis. From a total of 1,294 responses to the questionnaire, 793 data sets were included into the analysis (179 children with comorbidities and 614 healthy children). Responses were given at a median of 17 days after vaccination. Overall, safety of BNT162b2 was high in both cohorts. Psychological (OR: 3.56, [95% CI: 1.461 to 8.629]), pulmonary (OR: 7.14, [95% CI: 2.039 to 21.48]), gastrointestinal (OR: 2.35, [95% CI: 1.231 to 4.665]), neurological (OR: 1.74, [95% CI: 1.078 to 2.796]) and dermatological (OR: 2.28, [95% CI: 1.220 to 4.172]) side effects were increased in children with comorbidities over healthy controls. The higher rate of reported post-vaccination symptoms could either be due to a higher susceptibility for symptomatic effects following immune stimulation, or due to a trained awareness to health-related symptoms. The data emphasizes the importance to evaluate safety of the new mRNA COVID-19 vaccines not only in healthy children but also in children with comorbidities. To perform such evaluation should be made mandatory for pharmaceutical enterprises.

Research on current issues of self-medication among young people

The aim of the work is to determine the prevalence of self-medication among young people and their attitude to it, with the further development of recommendations for pharmacists regarding the prevention of negative consequences of self-medication and the improvement of pharmaceutical assistance (educational activities) in matters of responsible self-medication. Materials and methods. The work used methods of information search, survey, critical analysis, generalization, and interpretation of results. The survey took place online from January to May 2024, using the developed questionnaire (the electronic version was created using Google Forms). A total of 207 questionnaires were received from people aged 20–25. Results. Mostly, it is difficult for young people to determine their attitude toward self-medication. During treatment, a large number of research participants use the advice of doctors and pharmacists. 75.8 % of respondents always study the instructions for the medical use of drugs before using them. Basically, young people do not increase the dose of drugs arbitrarily to speed up their recovery. Almost half of them do not change the prescribed medications by the doctor to cheaper analogs. According to the research participants, half of them consider an adequate amount of drugs in the form of two names, and this is confirmed by the fact that 83.6 % of them had cases of simultaneous administration of more than one drug. After undergoing self-treatment, 75.8 % of respondents consider it not always practical, among which 13.5 % indicate that it was necessary to consult a doctor. Conclusions. The prevalence and attitude toward self-medication among young people were studied. The main reasons for self-medication are the difficulty of getting to a doctor’s appointment and lack of time, as well as the reduction of disease symptoms after self-diagnosis and the use of drugs and preventive measures. It should be noted, that 23.2 % of young people nevertheless turned to a doctor after receiving negative manifestations of self-medication, and half of the respondents shared their experience of self-medication. The obtained information can be useful for pharmacy institutions, which can use it to create a comprehensive model of a program for the prevention of negative consequences of self-medication, especially among young people, and increase patients’ commitment to the pharmaceutical enterprise.

Analysis of the Russian market of educational programs in the field of additional professional education for specialists of pharmaceutical companies

Abstract Aim conduct an analysis of the Russian market of educational programs in the field of additional professional education for specialists of pharmaceutical companies. Material and methods. The analysis of the market of educational programs was based on the data of the annual reporting of a number of institutions of higher education (reports on the results of the annual self-examination, reports on the results of activities and on the use of assigned state property, monitoring in the main areas of the educational institution of higher education, information and analytical materials based on the results of monitoring the effectiveness of activities educational institutions of higher education) for the period from 2017 to 2021. Based on data obtained, the share indicators of educational organizations in the Russian market of educational services in the field of additional education for specialists of pharmaceutical enterprises were determined. The share indicator was used to determine the concentration of educational services and the level of competition in the market using the concentration index and the Herfindahl-Hirschman index. In addition, during the work, such methods of analysis as generalization, methods of logical, systemic and comparative analysis, expert forecasting were used. Results. Based on the analysis, data were obtained on the profitability of the market for additional professional education services for pharmaceutical industry specialists; the presence of a high level of concentration of educational services in the market of additional professional education with a slight level of competition was established; the features of the implementation of additional professional training for specialists in the pharmaceutical industry are determined. Conclusion. The importance of additional professional education for specialists in the pharmaceutical industry has been confirmed. The further direction of development of the sphere of additional professional education for workers of pharmaceutical enterprises has been determined. The increase in the Russian market of additional educational programs based on current data on the development of the industry was justified. Recommendations have been formulated to expand the currently implemented programs of additional professional education based on the growing needs of the pharmaceutical market.

Does Government Environmental Concern Affect Enterprise Sustainable Development? Evidence from China

As the executor and agent of China’s environmental policy, local governments’ environmental concern reflects local governments’ determination in environmental governance. To figure out how the strengthening environmental concerns affect enterprises’ long-term activities, this study focuses on pharmaceutical manufacturing enterprises due to the enormous and complex composition of emissions. We apply bag of words to summarize relevant environmental words from the annual work reports in local governments to measure environmental concern. The empirical results of the OLS method reveal that the increasing environmental concerns of local governments did decrease the growth rate of chemical oxygen demand (COD) emission authentically. At the same time, it will inhibit the research and experimental development (R&D) activity intensity, but promote production efficiency of pharmaceutical manufacturing enterprises. After that, we discuss the heterogeneity of enterprise ownership, corporate social responsibility and regional regulatory strength of enterprises. Overall, we conclude that environmental concern did reduce COD emission and promote production efficiency, but it also has negative spillover effects. The novel contribution of this paper is that it enriches the trade-off between strengthening environmental compliance costs and long-term production and innovation activities. These results indicate that pharmaceutical manufacturing enterprises prioritize optimizing existing production processes instead of adopting efficient technology when complying with stricter environmental regulation. The reduction of R&D activities may pose risks to the long-term sustainable development of enterprises.

EVALUATION OF STUDENTS' TRAINING LEVEL IN THE ELECTIVE DISCIPLINE "QUALITY SYSTEMS IN PHARMACY"

The pharmaceutical industry is rapidly developing and implementing new innovative approaches and legal regulation of the quality management system of medicinal products, which includes a set of methods, processes and resources that are necessary for quality management. Therefore, the study by students of the specialty 226 "Pharmacy, industrial pharmacy" of the elective discipline "Quality systems in pharmacy" is an important area of professional training of a qualified specialist who will master the methodology of quality management, normative-legislative and organizational-economic aspects of quality control of medicinal products at pharmaceutical enterprises. Training of domestic students in the field of drug technology is an important direction of pharmaceutical education today. The main tasks of studying the elective discipline "Quality Systems in Pharmacy" are: formation of students of higher education in general knowledge about the quality indicators of medicinal products according to the stage of their life cycle by fulfilling the requirements of proper pharmaceutical practices and developing documentation in accordance with their requirements; formation of practical skills; raising the level of general and scientific development of students of higher education, forming their outlook and perspective as modern qualified specialists in the field of pharmacy. The purpose of the work was to study the assessment of the level of training of domestic students in the elective discipline "Quality Systems in Pharmacy". Materials and methods. We used an empirical research method (questionnaire). Questionnaire was a key research method, as it allows to get answers from the student audience regarding the organization of the educational process. A survey was conducted to assess the level of preparation of domestic students of the 5th year of the Faculty of Pharmacy who completed the study of the selective discipline "Quality Systems in Pharmacy". 50 full-time students and 2 distance learning students took part in the survey. Out of all the respondents, only one studies on budget forms of education. Research results. According to the curriculum, the elective discipline "Quality Systems in Pharmacy" at the Faculty of Pharmacy of IFNMU is studied in the V course in the IX semester, at the stage when students have already acquired basic knowledge of pharmaceutical disciplines. The discipline is chosen by already formed specialists who possess a large stock of theoretical knowledge and practical skills and are motivated to study a new subject, so it remains for the teacher to systematize information for the proper conduct of the discipline study course. 3 ECTS credits are provided for the study of the discipline in the curriculum. The discipline includes 20 hours of lectures, 30 hours of practical classes, 40 hours of independent student work and ends with a module. Lecture and practical material taught at the level of modern scientific and practical data with the aim of forming students' program results. We conducted an analysis of problems in the organization of the educational process for students of the Faculty of Pharmacy of the Ivano-Frankivsk National Medical University during full-time education. The success of implementing the selective discipline "Quality Systems in Pharmacy" and ensuring a high level of training depends primarily on the quality of the work of scientific and pedagogical workers.

Factors affecting the performance of government R&D support programs in pharmaceutical enterprises

Purpose The government support for research and development (R&D) initiatives in the pharmaceutical sector has been declining. The purpose of this study is to analyze factors influencing the efficacy of government R&D support programs directed at pharmaceutical enterprises in South Korea, aiming to provide valuable insights for policymakers responsible for resource allocation in the pharmaceutical industry. Design/methodology/approach The study uses data from 490 R&D projects conducted by 106 pharmaceutical enterprises between 2018 and 2020, sourced from the National Technical Information Service and Drug Approval Research and Technology repositories. The data were analyzed using negative binomial regression analysis operated by the Statistical Package for the Social Sciences. Findings Applied research, cooperative research and the number of doctoral researchers positively impact both the quantitative and qualitative performance of the papers. The number of doctoral researchers, government research funds and the ratio of private investment to total R&D investment positively impacted the quantitative and qualitative performance of patents. However, enterprise age negatively affected patent performance. Notably, sales were significantly associated with patent qualitative performance but not with patent quantitative performance. Originality/value While previous studies have primarily focused on specific types of government R&D support or individual sectors, this study provides a broader perspective by incorporating a variety of variables, to examine the overall performance of government R&D programs in the pharmaceutical sector. This paper addresses the growing concern over declining government support and offers insights that were not fully explored in prior studies. By doing so, this research highlights the importance of understanding how diverse factors collectively influence the effectiveness of government R&D support, providing new directions for innovation and excellence in the pharmaceutical industry.

Development of an intelligent model for management of the requirements of marketing projects of the pharmaceutical industry

The object of research is the processes of managing the requirements of the marketing project using means of intelligent data analysis and artificial intelligence systems. Marketing projects include a large number of projects of various types, formats and scales. The work considers projects that are initiated at an existing pharmaceutical enterprise that produces drugs for the local market. Over a period of time, the company needs to introduce new dosage forms to the market. It is not about the development of new innovative drugs. Usually, these are new mixtures of known components, but according to the results of global research, adding new components to the formulation gives a new, additional effect. Also, it can be a new form, for example, a spray or syrup for children, etc. Nevertheless, in order to produce such a new product and bring it to the market, to make a profit, it is necessary to conduct a study of the local market in order to find analogues, consumer expectations and predict future cash flows from sales of new drugs. In order to form requirements for the project of creating and manufacturing a new medicinal form, the company initiates marketing projects. Such marketing projects are the subject of research. As a result of the marketing project of the analysis of the drug market, it is necessary to form the contours of a new product and the requirements for the project of creating this product – a new medicinal product. Collecting and forming requirements is not a trivial task. Therefore, in the work, it is proposed to apply means of intelligent data analysis, which will be implemented on artificial intelligence systems. As a result, an intelligent model for managing the requirements of marketing projects of the pharmaceutical industry was developed. The non-triviality of the task of requirements formation is based on the fact that it is multi-criteria. The desired requirements and, accordingly, the future product of the project depend on: the lack of a similar dosage form on the local market, the presence of theoretical and practical pharmacological developments in this direction, the technical and financial capabilities of the enterprise, the expectations of stakeholders and consumers of the product. The use of intelligent tools will allow to avoid a conflict of requirements and to develop a medicine that will not only meet the expectations of all participants of the local pharmaceutical market, but also provide profit to the developing company.

Influence of Chinese National Centralized Drug Procurement policy on pharmaceutical corporate R&D investment

ABSTRACT The Chinese National Centralized Drug Procurement (CNCDP) policy has dramatically changed the Chinese drug market and influenced the production and R&D behaviour of pharmaceutical companies. This study empirically examined the impact of the CNCDP policy on pharmaceutical enterprises’ R&D investment and its mechanism using the difference-in-differences (DID) estimation. The findings demonstrate that this policy has a significant positive impact on corporate R&D investment. Moreover, selling expenses and accounts receivable play a crucial mediating role between them. However, there is no corresponding increase in the patent output of pharmaceutical enterprises. Heterogeneity analysis reveals that the policy exerts a more substantial influence on non-state-owned enterprises (non-SOEs) and chemical drug manufacturers than on state-owned enterprises (SOEs) and comprehensive firms. Therefore, it is recommended that the government continue to implement procurement policies, combat medical corruption, urge hospitals to pay promptly for medicines, broaden the scope of procured medicines, and promote the conversion of companies’ R&D investment into high-quality outcomes. These findings offer valuable guidance for developing countries in formulating policies to bolster the R&D competitiveness of their pharmaceutical industries and secure the supply of medicines.

Characterization and genome sequence of N,N-dimethylformamide degradation in Paracoccus sulfuroxidans DM175A1-1 isolated from activated sludge of wastewater.

N,N-dimethylformamide (DMF) is an organic solvent with stable chemical properties and high boiling point. Based on its good solubility, DMF is widely used in synthetic textile, leather, electronics, pharmaceutical and pesticide industries. However, the DMF pollutes the environment and does harm to human liver function, kidney function, and nerve function. Herein, an efficient DMF-degrading strain, DM175A1-1, was isolated and identified as Paracoccus sulfuroxidans. This strain can use DMF as the sole source of carbon and nitrogen. Whole-genome sequencing of strain DM175A1-1 revealed that it has a 3.99-Mbp chromosome a 120-kbp plasmid1 and a 40-kbp plasmid2. The chromosome specifically harbors the dmfA1 and dmfA2 essential for the initial steps of DMF degradation. And it also carries the some part of genes facilitating subsequent methylotrophic metabolism and glutathione-dependent pathway. Through further DMF tolerance degradation experiments, DM175A1-1 can tolerate DMF concentrations up to 10,000 mg/L, whereas the majority of Paracoccus strains could only show degradation activity below 1,000 mg/L. And the efficiency of organic nitrogen conversion to NH3-N in DMF can reach 99.0% when the hydraulic retention time (HRT) is controlled at 5 days. Meanwhile, it showed a significant degradation effect at a pharmaceutical enterprise in Zhejiang Province with high concentration of DMF wastewater. This study provides a new strain Paracoccus sulfuroxidans DM175A1-1 which shows a significant influence on DMF degradation, and reveals the characterization on its DMF degradation. It lays the foundation for the application of biological method in the efficient degradation of DMF in industrial wastewater.

NK model simulation study of intelligent manufacturing transformation path selection in pharmaceutical manufacturing enterprises

Under the wave of Industry 4.0, traditional pharmaceutical manufacturing enterprises are in urgent need of intelligent manufacturing transformation and upgrading, and exploring the optimal realization path of intelligent manufacturing transformation can help accelerate the transformation process of pharmaceutical manufacturing enterprises. This paper uses grounded theory research methods to conduct a multi-case study to summarize six influencing factors of the intelligent manufacturing transformation of Chinese pharmaceutical manufacturing enterprises; and then analyzes the correlation between the intelligent manufacturing influencing factors based on the DEMATEL method and the NK model, and identifies the key influencing factors according to this, and then draws the fitness landscape map of the intelligent manufacturing transformation, and finally arrives at the optimal path selection of the intelligent manufacturing transformation of pharmaceutical manufacturing enterprises. The study enriches and extends the research paradigm of intelligent manufacturing transformation, and provides lessons for pharmaceutical manufacturing enterprises to realize intelligent manufacturing transformation and upgrading.

An integrated group decision support framework utilizing Pythagorean fuzzy DEMATEL–CoCoSo approach for medicine cold chain logistics provider selection

PurposeThe purpose of this study is to establish a synthetic group decision framework based on the Pythagorean fuzzy (PF) set to select the optimal medicine cold chain logistics provider (MCCLP). Fierce market competition makes enterprises must constantly improve every link in the process of enterprise sustainable development. The evaluation of MCCLP in pharmaceutical enterprises is an important link to enhance the comprehensive competitiveness. Because of the fuzziness of expert cognition and the complexity of the decision procedure, PF set can effectively handle the uncertainty and ambiguity in the process of multi-criteria group decision decision-making (MCGDM).Design/methodology/approachThis paper develops an integrated group decision framework through combining the Decision-Making Trial and Evaluation Laboratory (DEMATEL) technique and combined compromise solution (CoCoSo) approach to select a satisfactory MCCLP within PF circumstances. First, the PF set is used to process the ambiguity and uncertainty of the cognition ability of experts. Second, a novel PF knowledge measure is propounded to measure the vagueness of the PF set. Third, a comprehensive criterion weight determination technique is developed through aggregating subjective weights attained utilizing the PF DEMATEL approach and objective weight deduced by knowledge measure method. Furthermore, an integrated MCGDM approach based on synthetic weight and CoCoSo method is constructed.FindingsThe outcomes of sensibility analysis and comparison investigation show that the suggested decision framework can help decision experts to choose a satisfactory MCCLP scientifically and reasonably. Accordingly, the propounded comprehensive decision framework can be recommended to enterprises and organizations to assess the MCCLP for their improvement of core competitiveness.Originality/valueMCCLP selection is not only momentous for pharmaceutical enterprises to improve transportation quality and ensure medicine safety but also provides a strong guarantee for enterprises to improve their core competitiveness. Nevertheless, enterprises face certain challenges due to the uncertainty of the assessment environment as well as human cognition in the process of choosing a satisfactory MCCLP. PF set possesses a formidable capability to address the uncertainty and imprecision information in the process of MCGDM. Therefore, pharmaceutical enterprises can implement the proposed method to evaluate the suppliers to further improve the comprehensive profit of enterprises.

Research on Supplier Selection of Pharmaceutical Enterprises under the Dual Carbon Target

With the proposal of national carbon peak and carbon neutrality targets, green supply chain management has become one of the important means of reducing carbon emissions. Based on elaborating on the connotation of new quality productivity, this article analyzes the supplier selection problem of pharmaceutical enterprises under the dual carbon target. A pharmaceutical supplier evaluation index system has been established from five aspects related to low-carbon and environmental protection, including technological innovation, research and development capabilities, digitization, intelligent production, environmental protection technology, and so on, with five primary indicators and 18 secondary indicators. Secondly, a game theory combination weighting method combining the G1 method and entropy weight method is used to determine the weights of indicators. A pharmaceutical supplier evaluation model is established by combining the matter element extension model. A company is used as an example to evaluate its 8 candidate suppliers and select the best supplier. Finally, corresponding measures are proposed to promote the healthy and sustainable development of pharmaceutical enterprises.

Can intelligent manufacturing drive green development in China's pharmaceutical industry? -- Evidence from listed enterprises

The pharmaceutical industry's historical extensive pollution emissions have caused severe environmental issues. In the context of the evolving intelligent age, it is urgent to investigate the potential of intelligent manufacturing in improving the environmental performance of the pharmaceutical industry. Our study employs panel data from 110 publicly listed pharmaceutical enterprises covering the period from 2012 to 2020 to assess the impact of intelligent manufacturing on the environmental performance of the pharmaceutical sector. The results reveal a substantial positive effect of intelligent manufacturing on the environmental performance of these enterprises. Additionally, we identify three primary mechanisms for this enhancement: supply chain optimization, the emergence of technological innovations, and structural optimization. A notable observation is that enterprises not certified in environmental management systems or operating within highly competitive markets exhibit a greater potential for enhancing their environmental performance. Drawing upon these insights, our study proposes detailed policy recommendations to leverage intelligent manufacturing for the sustainable progression of the pharmaceutical industry.

Membrane Physiology Symposium April 22nd-23rd, 2024, Napa California, USA.

The Membrane Physiology Symposium was created with the goal of joining basic research with technology companies, where questions and conversations are open and welcomed in a universal language. For many years, academic physiology research areas have been naturally siloed into their own niche communities, which can surely be beneficial. Linking different technological application areas with varied research sectors is an integral formula for successful scientific breakthroughs. The meeting covers a wide variety of topics related to channelopathies, neurological and cardiac disease, drug development, and therapeutic applications, with research programs represented by core academic facilities, medical science institutions, small and large pharmaceutical enterprises, as well as novel cell-based and reagent providers. For this reason, gathering the brightest minds of all relevant fields in one integrative forum is essential for new avenues of discovery, development, and process optimization to occur.

Can the digital transformation of pharmaceutical enterprises' finance improve healthcare equity?

Using big data, cloud computing, and blockchain technologies, enterprise finance is gradually transitioning towards digital transformation. Academia has already researched the motivations, efficiency improvements, and ethical impacts of the digital transformation of enterprises' finances. However, there is little research from the social equity perspective to explore the impact of enterprise financial digitization transformation on regional social welfare. As important entities for improving residents' health conditions, pharmaceutical enterprises have not fully studied whether their financial digitization transformation can improve the quality and efficiency of healthcare services and enhance regional healthcare equity. Therefore, this study focuses on listed Chinese pharmaceutical enterprises from 2018 to 2022, empirically examining the impact of pharmaceutical enterprises' digital transformation on regional healthcare equity. Using A Hospital in China as a case study, the process of its financial digitization transformation is deeply analyzed. The results show that the financial digitization transformation of pharmaceutical enterprises has a significant positive impact on regional healthcare equity, and it can be further enhanced by improving financial flexibility and increasing data assets. These findings contribute to accurately assessing the social responsibilities of pharmaceutical enterprises and provide new perspectives and evidence for improving regional social welfare levels.

Exploring the Impacts of Green Supply Chain Integration and Ambidextrous Green Innovation on the Financial Performance of China’s Pharmaceutical Manufacturing Enterprises

This study focuses on the factors affecting the financial performance of pharmaceutical manufacturing enterprises. Based on dynamic capability theory and ambidextrous innovation theory, this study adopts the Resource–Behavior–Performance framework to investigate how green supply chain integration (GSCI) and ambidextrous green innovation affect financial performance. The proposed hypotheses were tested through structural equation modeling using data from 400 China’s pharmaceutical manufacturing enterprises. The results indicate that the various dimensions of GSCI and ambidextrous green innovation yield distinct outcomes. Among the three dimensions of GSCI, only green supplier integration and green customer integration significantly impact financial performance directly, unlike green internal integration. Among the two dimensions of ambidextrous green innovation, only exploitative green innovation significantly influences financial performance, acting as a mediator between the GSCI dimensions and financial performance, while exploratory green innovation does not. The main advantages of this study include considering the connotation and value of GSCI from a green dynamic capability perspective, as well as the effects of exploratory and exploitative green innovation as intermediary behaviors while simultaneously considering the performance effects of GSCI and ambidextrous green innovation. This study offers novel academic insights and practical guidelines for pharmaceutical manufacturing enterprises to integrate GSCI and ambidextrous green innovation, with the aim of achieving better financial performance in their sustainable development efforts.

Practical Research on the Comprehensive Quality of School-Enterprise Joint Precision Training of Higher Vocational Pharmacy Professionals

With the deepening of China's higher vocational education reform, the innovation of talent training mode has become the key to improve the quality of education and adapt to the needs of society. Especially in the field of pharmacy, the comprehensive requirements for the quality of professional and technical personnel are increasing day by day. Centering on the precise training mode of school-enterprise cooperation, this paper conducts practical research on the comprehensive quality training of pharmacy professionals in higher vocational colleges, aiming to explore and optimize the talent training program, in order to better adapt to the diversified needs of the development of enterprises in the industry. The research adopts the method of combining quantitative data analysis with qualitative research, and many representative pharmaceutical enterprises were selected to carry out research together with five higher vocational colleges in the province. Through in-depth interviews with 100 students and 40 corporate instructors, as well as tracking the student internship and project cooperation process, multi-dimensional data including internship effectiveness, skill mastery level, job adaptability and innovative thinking ability were collected. The research results show that the precise training mode of school-enterprise cooperation has significantly improved students' professional skills and practical ability, and the employment rate of students has increased by 15% compared with the traditional mode. However, the survey also found that this model is insufficient in terms of students' independent learning ability and the depth of theoretical knowledge. To this end, the research puts forward targeted improvement measures, such as increasing case teaching, simulation experiment and enterprise internal training, to strengthen students' self-study ability and innovative thinking. The conclusions and suggestions of this study provide a reference for the school-enterprise cooperation mode in other professional fields, and have certain guiding significance and practical value for the development of local higher vocational education.

Can the separation of marketing authorization from manufacturing authorization stimulate pharmaceutical innovation? Evidence from China's pharmaceutical industry reform

Using data from A-share pharmaceutical manufacturing listed companies between 2011 and 2021, this paper constructs a difference in differences (DID) model to systematically analyze the impact of China's Marketing Authorization Holder (MAH) system pilot policy on pharmaceutical enterprise innovation. Our findings indicate that implementing the MAH system can significantly stimulate innovation in pharmaceutical enterprises, both in terms of input and output. Additionally, local intellectual property protection positively moderates the incentive effect of MAH system on pharmaceutical innovation. The results of our heterogeneity analysis further demonstrate that the pilot policy of the MAH system exerts a stronger incentive effect on the innovation behavior of non-state-owned enterprises and enterprises in the growth and mature stage. Moreover, we provide evidence for the long-term impact of MAH system on innovation within pharmaceutical companies.

Do artificial intelligence system adoptions foster production management supply chain performance in pharmaceutical manufacturing firms? An empirical exploring study from the MENA region

PurposeThe goal of this study is to better understand the driving force behind the use of artificial intelligence (AI) in pharmaceutical manufacturing firms (PMFs) that are recognized as developing countries in the Middle East and North Africa (MENA) region that are listed by the Chambers of the Industries of Jordan, the Kingdom of Saudi Arabia, Morocco, and Algeria. Furthermore, the effect of adopting and using AI in managing raw materials (RMs), products, parts, and components for PMFs through supply chains (SCs).Design/methodology/approachA self-administrated questionnaire survey was used to gather data from 95 out of 511 participating managers (e.g. manufacturing, supplying, IT, operational, and logistical managers) utilizing a quantitative technique with a random sample size. In fact, 18.8% of the 89 different manufacturing firms (MFs) in the MENA area responded, with five to six managers from each company. The raw data was analyzed using partial least squares structural equation modeling (PLS-SEM).FindingsThe study’s findings show that the readiness to embrace artificial intelligence (AI) in the production management supply chain performance (PMSCP) of pharmaceutical manufacturing firms in the Middle East and North Africa (MENA) is positively and significantly influenced directly and indirectly by sustainable strategic supplier reliability (SSSR), shipping process dependability (SPD), technological factors (TFs), and infrastructure transformational development capability (ITDC).Originality/valueAs the studied countries are growing economies, such study findings might offer insightful consequences for stakeholders and policymakers regarding the significance of using artificial intelligence system adoptions in pharmaceutical manufacturing enterprises in the MENA region. The managers may also concentrate on the strong positive direct and indirect links between SSSR, SPD, TFs, and ITDC preparedness to accept AI adoption and its applications and systems in supply chain and production management departments and the consequences of informational and product delivery.

Organization of reviews of a pharmaceutical enterprise quality management system functioning

Aim. To determine the state of organizing the process of analyzing the quality management system of a typical pharmaceutical enterprise in accordance with the current industry requirements of Good Manufacturing Practice and the ISO 9001:2015 standard, as well as substantiating effective approaches to improving this activity. Materials and methods. We used analysis, comparison, questionnaires, surveys and direct observations. The results were processed and verified using licensed Microsoft Office Excel software products. Results. The relevance of the development of quality management systems (QMS) of domestic pharmaceutical organizations in the period of martial law has been proven. The requirements of the DSTU ISO 9001:2015 standard, as well as the requirements of the guidelines on Good Manufacturing Practice (GMP) of medicines for reviewing and analyzing QMS of pharmaceutical enterprises (PhE) have been analyzed. Approaches to the organization of QMS review at a number of domestic PhE have been studied; as a result, typical inconsistencies of these procedures have been determined. Based on the results of the study and the experience analyzed in supporting the QMS functioning of PhE, effective organizational approaches have been identified, and recommendations are given for the effective analysis of QMS of PhE. Conclusions. In the study conducted, a review of the practice of analyzing QMS at a number of domestic and foreign PhE has been carried out, and typical inconsistencies of this process have been identified and systematized. The requirements of the DSTU ISO 9001:2015 standard, as well as the industry requirements of the GMP guidelines for reviewing and analyzing the quality system of PhE have been analyzed. Based on the results of the research and the authors’ own experience in implementing and supporting the QMS functioning of PhE, the main organizational approaches and recommendations for analyzing QMS of PhE have been determined.