Exploring the innovative talents training mode in new era / 生物工程学报

Innovation is an important way to promote economic development and social progress. Recent years have seen rapid development of biological sciences. In response to social demands and the needs for developing an innovative country, fostering innovative talents in the field of biosciences has become a significant initiative supported by national policies and the needs from talent market. Taking the innovative talent training mode implemented by Zhejiang Normal University in the field of biological sciences as an example, this paper comprehensively introduces several key aspects of the mode. This includes establishing a mentorship system as the foundation, carrying out curriculum reform through project competitions and practical platforms, and promoting synergy among industry, academia, and research in talent training. This training mode has achieved positive results in practice, promoting the training of outstanding innovative talents in biological science majors, and may facilitate the reform of talent training in similar majors.

Strategy and challenge of innovative drug research and development from clinically effective ingredients of traditional Chinese medicine / 中国中药杂志

Novel drug discovery from the active ingredients of traditional Chinese medicine is the most distinctive feature and advantageous field of China, which has provided an unprecedented opportunity. However, there are still problems such as unclear functional substance basis, action targets and mechanism, which greatly hinder the clinical transformation of active ingredients in traditional Chinese medicine. Based on the analysis of the current status and progress of innovative drug research and development in China, this paper aimed to explore the prospect and difficulties of the development of natural active ingredients from traditional Chinese medicine, and to explore the efficient discovery of trace active ingredients in traditional Chinese medicine, and obtain drug candidates with novel chemical structure, unique target/mechanism and independent intellectual property rights, in order to provide a new strategy and a new model for the development of natural medicine with Chinese characteristics.

Study on French medical insurance payment policy for innovative medical products paid under DRG / 中国药房

OBJECTIVE To analyze the implementation experience of France’s additional list system for innovative medical products， and to provide reference for China to support medical institutions to use innovative medical products. METHODS Taking France as a case study， using policy analysis method， this paper systematically studied the practice of establishing additional list system to compensate for innovative medical products in France under diagnosis-related group （DRG） payment， including the establishment background， selection procedure and implementation effect. The suggestions were provided on the medical insurance payment methods for innovative medical products in China. RESULTS & CONCLUSIONS The additional list system established a compensation and payment system for innovative medical products with significant clinical efficacy but high treatment cost， covering four stages： application， evaluation， payment and adjustment， which effectively reduced the drug burden on medical institutions， promoted the use of innovative pharmaceutical products by medical institutions， and stimulated the innovation drive of the pharmaceutical industry， but at the same time brought payment pressure to the medical insurance fund. With the rapid spread of our DRG/diagnosis-intervention packet payment reform of China， some regions have also explored the establishment of a compensation and payment mechanism for innovative medical products， but there are still imperfections. We can refer to the implementation experience of the French additional list system and establish an effective compensation and payment system for innovative medical products starting from the establishment of selection criteria， the selection of compensation mode and the implementation of dynamic adjustment.

Exploration and practice of innovative teaching of molecular biology experiment course under the context of new agricultural science / 生物工程学报

The development of new agricultural science is a new idea and a new measure that aims to deepen the reform of higher education in agriculture and forestry for the development of new agriculture, new countryside, new farmers and new ecosystem. It is therefore essential for the current undergraduate experimental teaching reform to timely introduce new technologies and new methods used in the development of agriculture and forestry industry into the experimental course teaching, and promote the integration of professional education with innovation and entrepreneurship education, according to the requirements of the new agricultural science. In view of this, the exploration and practice of molecular biology experiment course was carried out from the perspective of experimental projects, teaching modes and evaluation methods, according to the teaching requirements and characteristics of molecular biology experiment and teachers' scientific research achievements. The results showed that this reform greatly improved the students' comprehensive quality and innovation ability and may facilitate the innovation experiment teaching of other courses.

Mediating role of innovation self-efficacy in the relationship between sense of organizational fairness and innovation behavior in nurses / 中国职业医学

Objective To study the relationship among the sense of organizational fairness, innovative self-efficacy (ISE) and innovative behavior in nurses. Methods A total of 392 nurses from a grade A tertiary hospital were selected as the research subjects using convenience sampling method. The Organizational Fairness Scale, Innovation Self-efficacy Scale, and Innovation Behavior Scale were used to evaluate the sense of organizational fairness, ISE, and innovation behavior, respectively. The mediate equation model was constructed, and Bootstrap analysis was applied for validation. Results The scores for organizational fairness, ISE, and innovative behavior among the nurses were (67.8±15.2), (23.9±3.5), and (30.5±6.7) points, respectively. Organizational fairness score was positively correlated with both innovative behavior and ISE scores ［correlation coefficients (r) were 0.38 and 0.36, respectively, both P<0.01］. ISE score was positively correlated with innovative behavior total score (r=0.51, P<0.01). The results of the mediation analysis indicated that the total effect of organizational fairness on innovation behavior was 0.34 (P<0.01),with a direct effect of 0.17 (P<0.01). ISE plays a mediating role between organizational fairness and innovation behavior among nurses(P<0.01) with standardized mediation effect of 0.17, accounting for 50.0% of the total effect. Conclusion Organizational fairness can influence the ability of innovative behavior directly or through the mediating role of ISE.

Current status and future prospects of stomatology research / 浙江大学学报（英文版）（B辑：生物医学和生物技术）

Research in stomatology (dental medicine) continues to expand globally and is oriented towards solving clinical issues, focusing on clarifying the clinical relevance and potential mechanisms of oral‍-‍systemic connections via clinical epidemiology, oral microecological characterization, and the establishment of animal models. Interdisciplinary integration of materials science and tissue engineering with stomatology is expected to lead to the creation of innovative materials and technologies to better resolve the most prevalent and challenging clinical issues such as peri-implantitis, soft and hard tissue defects, and dentin hypersensitivity. With the rapid development of artificial intelligence (AI), 5th generation mobile communication technology (5G), and big data applications, "intelligent stomatology" is emerging to build models for better clinical diagnosis and management, accelerate the reform of education, and support the growth and advancement of scientific research. Here, we summarized the current research status, and listed the future prospects and limitations of these three aspects, aiming to provide a basis for more accurate etiological exploration, novel treatment methods, and abundant big data analysis in stomatology to promote the translation of research achievements into practical applications for both clinicians and the public.

Approval Status and Suggestions on Supervision of Class II Innovative Medical Device / 中国医疗器械杂志

Based on the current situation of approval and publicity of class II innovative medical devices in various provinces and cities, especially after analyzing the problems found in the review of class II innovative medical devices in Shanghai and the factors affecting the listing process of innovative medical devices, this study puts forward some thoughts on supervision for reference in establishing and perfecting systems and regulations, changing the review and approval thinking, extending services to the development of innovative medical devices and the formulation of clinical trial schemes.

Innovative strategies developed to mitigate the impact of COVID-19 pandemic on polio surveillance in Nigeria, 2020

Introduction: following the spread of the COVID-19 pandemic to Nigeria, the Federal Government of Nigeria restricted human and vehicular movements to curb the spread of the disease. This action had a negative impact on Acute Flaccid Paralysis (AFP) surveillance, with a resultant reduction in the number of AFP cases reported. This paper describes the impact of the COVID-19 pandemic on poliovirus surveillance in Nigeria and the proactive interventions by Nigeria´s polio program to mitigate the impact of COVID-19 on polio surveillance. Methods: nine innovative strategies were implemented in all 774 Local Government Areas (LGA) of the 36 states and Federal Capital Territory (FCT) of the country. These strategies were developed by the national surveillance officers and operationalized by sub-national surveillance officers with different strategies starting at different epidemiological weeks from week 14 to 23, 2020. Many of the strategy innovations were technology-based and included: the use of mobile phones to send the AFP case definition and video by WhatsApp or by SMS, the use of state-specific toll-free numbers and Mobile Telephone Network (MTN) (mobile service provider) CallerfeelTM to community informants (CI) who were the main targets of the interventions to increase case detection and reporting. Others included the use of abridged e-surveillance integrated supportive supervision (ISS) checklists, virtual monthly DSNO meetings, and batched AFP stool specimen transportation network. Results: compared to the same period in 2019, the cumulative rate of AFP case detection and reporting had gradually declined from 39.1% in January to 16.7% before the commencement of the interventions in week 20, 2020. However, the detection and reporting increased by 57.% from week 20 to week 47 compared to the same period in 2019. This is because with COVID-19, hospital visitation dropped, and the sick remained in the communities, so the CI network was relied on to detect and report AFP cases. The cumulative proportion of AFP cases reported by community informants as of week 47 increased from 13% in 2018 to 21% in 2020. This indicates an increase of 38%. Thirty-five AFP cases were detected and reported using the MTN Caller Feel strategy, while 15 cases were reported through state-specific toll-free numbers. Conclusion: the implementation of the innovative strategies was able to mitigate the low AFP case detection and reporting observed at the initial stage of the COVID-19 pandemic. The use of technology facilitated reaching the CI network, which was more instrumental in detecting and reporting the cases.

SCHOOL LEADERSHIP: PERSPECTIVES ON ORGANIZATIONAL LEARNING IN CONTEXT OF LIFE SKILLS

Leadership is a complex multi-faceted phenomenon. Signi?cant school wide change is impossible without effective school leadership. Life Skills is a role orientation and consistent with predictions, results suggest that different patterns of Skills lead to different forms of organizational learning. There are many passionate advocates already providing strong leadership development who have dedicated their work to make schools learning communities that support leadership learning. School Head must be enabled and encouraged to analyze comprehensively and respond knowledgeably to the local context and work closely with and through their colleagues to establish good working relationship with staff. it is the prime duty of school head to promote quality teaching of teachers to meet the high level of learning for all children in their classes. School principal /head has the most signi?cant in?uence on teacher's professional development and also on student's learning. School head is directly responsible for leading learning by creating a conducive environment for learning.

It is story time!! Storytelling – Narrative session by medical students, an effective way of reflection of learning pharmacology

Background: Pharmacology, the study of drugs, is loaded with thousands of drug names, their mechanism of action, and adverse effects to be memorized, among which the drugs acting on central nervous system, especially antipsychotics, is a night mare for every medical student. “The Storytelling method” is implemented to increase the knowledge of students on antipsychotic drugs using storytelling method as an effective teaching strategy. Aims and Objectives: The aims of this study were to evaluate the effect of reflective writing in learning Pharmacology, among 2nd year MBBS students in the form of storytelling. Materials and Methods: Fifty students from 2nd year MBBS Students were involved in this teaching strategy. Students were randomly divided into ten groups (five per group). They were instructed to frame their own story/case scenario of a psychotic person treated with a P (Personalized) drug of their choice, the specific adverse effect encountered, and the methods to combat it. A time duration of 15 min was given and one person from each group had to narrate their story with voice modulation and hand gestures, for a maximum of 5 min. Results: Validated questionnaire is used for assessing the effectiveness of “storytelling method.” Six of the questions were quantitative and two were qualitative. More than 90% (n = 45) students described the storytelling session as “Creative and Fun filled” when compared to routine classes. Ninety-four percentage (n = 47) of students responded that “Storytelling” session improved their creative thinking on the subject. Conclusion: Storytelling strategy in pharmacology can help students in better understanding of the drug action and their adverse effects than traditional teaching methods.

Modelo de negocios en la salud e investigación clínica: la cuestión de las patentes en la ciencia

Propósito/Contexto. En este artículo se exponen las tendencias y las características de un modelo de negocio que la industria farmacéutica ha venido imponiendo con la ayuda del desarrollo de nuevos medicamentos a los que se les cuestiona su "altura inventiva" y que, a pesar de ello, les son otorgadas las patentes de segunda generación, considerándose esta una práctica abusiva y que favorece el incremento de los precios de estas innovaciones en el mercado. Metodología/Enfoque. Mediante la presentación de un caso: "la declaración de interés público del medicamento imatinib en Colombia" se identifican las estrategias y las maniobras anticompetitivas que dejan pocas oportunidades a los Estados para distribuir de manera equitativa los beneficios de las invenciones de medicamentos. En el análisis bioético del caso se caracteriza el dilema como tipo práctico, esto es, aquel en el que persisten requerimientos morales en tensión con un interés privado, en esta ocasión, entre la salud pública, por un lado, y la propiedad intelectual como política internacional, por el otro. Resultados/Hallazgos. La tesis es que este es un problema transfronterizo sintomático de la falta de justicia global en razón a la suplantación del sentido de "bien común" que ha acallado los vínculos sociales, solidarios y colaborativos. Discusión/Conclusiones/Contribuciones. Se insta a un consenso sobre las bases sociales y el respeto de la dignidad de las personas, un mandato de solidaridad superior en beneficio del bien común y el "florecimiento de la humanidad".

Objetivo/Contexto. Este artigo expõe as tendências e características de um modelo de negócio que a indústria farmacêutica tem vindo a impor com a ajuda do desenvolvimento de novos medicamentos cujo nível de inventividade é questionado. Como resultado, é-lhes concedidas patentes de segunda geração, o que é considerado uma prática abusiva e favorece o aumento dos preços destes inovações no mercado. Metodologia/Abordagem. Através da apresentação de um caso "A Declaração de Interesse Público da droga Imatinib na Colômbia", são identificadas estratégias e manobras anticompetitivas, que deixam poucas oportunidades para os Estados distribuírem os benefícios das invenções de drogas de forma equitativa. Na análise bioética do caso, o dilema é especificado como sendo prático, ou seja, um dilema em que os requisitos morais persistem em tensão com um interesse privado, neste caso, entre a saúde pública, por um lado, e a propriedade intelectual como uma política internacional, por outro. Resultados/Descobertas. A tese é que se trata de um problema transfronteiriço sintomático de falta de justiça global devido à suplência de um senso o bem comum que silenciou os laços sociais de solidariedade e colaboração. Discussão/Conclusões/Contribuições. Apela a um consenso sobre os fundamentos sociais e o respeito pela dignidade das pessoas, um mandato de maior solidariedade em benefício do bem comum, o florescimento da humanidade.

Purpose/Background. This article exposes the tendencies and characteristics of a business model that the pharmaceutical industry has been imposing with the help of the development of new drugs whose degree of inventiveness is questioned. As a result, they are granted second generation patents, which is considered an abusive practice that favors the increase of the prices of these innovations in the market. Methodology/Approach. Through the presentation of a case "The Declaration of Public Interest of the Drug Imatinib in Colombia", anti-competitive stra-tegies and maneuvers are identified, which leave few opportunities for the States to distribute the benefits of drug inventions in an equitable manner. In the bioethical analysis of the case, the dilemma is specified as a practical one, that is, one in which moral requirements persist in tension with a private interest, in this case, between public health on the one hand, and intellectual property as an international policy, on the other. Results/Findings. The thesis is that this is a cross-border problem symptomatic of a lack of global justice due to the supplanting of the sense of the common good that has silenced social bonds of solidarity and collaboration. Discussion/Conclusions/Contributions. It calls for a consensus on social foundations and respect for the dignity of persons, a higher mandate of solidarity for the benefit of the common good, and the flourishing of humanity.

The Effect of Thriving and Workplace Spirituality on Innovative Work Behavior and Career Adaptability Among Railway Employees

Introduction-This research aimed to study the effect of Thriving and Workplace Spirituality on Innovative Work Behavior and Career Adaptability among railway employees (TC) because of the competitive environment they experience. Method- The participants were 105 railway employees between the age of 40-60 years, residing in Mumbai, Maharashtra. The purposive and snowball sampling methods were used for the study. The scales used were - Thriving at work scale (Porath et al,2012), Spirit at work scale (SAW) (Kinjersky, 2013), Innovative work behavior ( Jesson, 2009), Career Adapt Abilities Scale – short form (CAAS- SF) (Maggiori et al, 2012). The data were analyzed using 4 independent ‘t tests’. Results-Thriving had a significant effect on Innovative Work Behavior and Career Adaptability among railway employees. Thus Thriving might act as an advantage in the competitive work environment of TCs. Since Thriving cannot be developed individually as a skill, there is a need to study Workplace Spirituality. Results obtained suggest that there was no significant effect of Workplace Spirituality on Innovative Work Behavior which can be attributed to the Covid-19 situation. Later analysis shows that Workplace Spirituality has a significant effect on Career Adaptability, suggesting that the Workplace Spirituality plays will help in better career adaptability among railway employees. Conclusion- Thriving is considered to be a human aspect of sustainability which is important to produce high performance. Thus if we can enhance Workplace Spirituality for railway employees, they might experience Thriving which will eventually contribute to enhancing IWB and Career Adaptability.

Practice and exploration on the safety management of undergraduate students' innovative and practical platform in local universities under the background of "innovation and entrepreneurship" / 中华医学教育探索杂志

Innovative and practical platform safety management is the foundation of the innovation and entrepreneurship for undergraduate students in universities and colleges, which plays a critical role in maintaining the stability of the university and society, and ensuring the safety of teachers and students. In this present paper, the complex situation and problems of innovative and practical platform safety management, such as the imperfect regulations, weak atmosphere, incomplete facilities, unprofessional management, etc., are discussed under the background of "innovation and entrepreneurship" in China. With the combination of the above problems and the actual situation of Chengdu Medical College, the constructions of the regulations, such as access regulation, certification regulation, check regulation, rewards and punishment regulation, responsibility regulation, and a series of standard operating procedures (SOP) have also been carried out. Furthermore, adequate safety education and proper safety drills have been performed during the whole process of safety management. In addition, a diverse and professional management team with putting more emphasis on the development of safety facilities has been formed. In conclusions, the practice and exploration on the safety management of undergraduate students' innovative and practical platform in this paper may provide a theoretical basis and practical value to optimize the safety management in local universities and colleges under the background of "innovation and entrepreneurship" in China.

Application of the combined use of curriculum ideological and political education and CDIO mode in the cultivation of stomatological top-notch innovative personnel / 中华医学教育探索杂志

Objective:To explore the teaching effect of the combined use of curriculum ideological and political education and CDIO (connective, design, implement, operate) mode in the cultivation of stomatological top-notch innovative personnel.Methods:The research subjects were undergraduate students from School of Stomatology, Tongji Medical College, Huazhong University of Science and Technology, who participated in stomatological top-notch innovative personnel training program in 2018 and 2019. CDIO was applied to control group, the combined use of curriculum ideological and political education and CDIO mode was applied to experimental group. After the training, the students' research and innovation capacity was examined and the teaching efficiency of these two models was reflected by the students' questionnaire. SPSS 20.0 software was used for t test. Results:In terms of research and innovation capacity, students scored significantly better in professional English, concluding report, papers publishing, and field defense in experimental group than in control group [(22.43±0.61) vs. (18.49±0.77), (22.48±0.32) vs. (19.05±0.53), (23.69±0.33) vs. (21.89±0.52), and (22.78±0.48) vs. (20.43±0.56), respectively, P<0.05]. The students in experimental group highly agreed with the teaching efficiency of the combined use of curriculum ideological and political education and CDIO mode. Conclusion:The combined use of curriculum ideological and political education and CDIO mode could enhance subjective initiative, sense of identity, sense of pride, sense of belonging, cultivation of multi-dimensional ability, thus helping to form a novel system of stomatological top-notch innovative personnel training.

Review and reflection of curriculum reform in medical functional experiment / 中华医学教育探索杂志

The following curriculum reforms in medical functional experiment have been performed in Guangzhou Medical University: taking comprehensive experiments as main contents, supported by self-designed experiments and innovative experiments after class, applying the blended teaching mode by combining virtual simulation experiments and animal experiments, setting up "simulative functional experiment" as an optional course based on intelligent simulated human system, and developing medical popular science education for teenagers. Questionnaire results show that, through these reforms, remarkable effects have been achieved in students' integrated practical ability, scientific accomplishment, clinical and innovative thinking ability.

International experience about the applications of drug Managed Entry Agreements and its enlightenment to China / 中国药房

OBJECTIVE To boost access to medical insurance for drugs and improve the accessibility and affordability of drugs. METHODS The current status of the application of international and domestic drug Managed Entry Agreement （MEA）were investigated through literature research method and other methods ，and analyzed comparatively from the aspects of the scope of agreement drugs ，the types of agreements and the content of the agreement ，etc. The problems existing in the application of drug MEA in China were summarized to put forward the suggestions. RESULTS & CONCLUSIONS The UK ，Australia and Italy had rich experience in the application of drug MEA ，and the operation management mechanism were complete. The scope of drugs included in MEA in these countries were relatively broad and the types of agreements were relatively diversified. In China ，drugs included in MEA were mainly oncology drugs and rare disease drugs. The types of agreements mainly included “finance-based agreements”and effect guarantee/effect-based payment in individual-level of“performance-based agreements ”. China ’s evidence collection platform was imperfect and lacked standardized process of MEA. It is suggested that stakeholders should consider increasing the types of drugs ，diversified types of agreements ，improving the accuracy and continuity of evidence collection ， establishing a standardized process for MEA.

Trace therapeutic substances of traditional Chinese medicine: great resources of innovative drugs derived from traditional Chinese medicine / 中国中药杂志

The traditional Chinese medicine(TCM) contains very complex constituents. Besides the major constituents, there are a large number of unclear trace constituents with novel skeletons and potent bioactivities, which have been regarded as one of the important therapeutic substances and the great resources of innovative drugs derived from TCM. The present review highlighted that the development of the trace therapeutic substances of TCM is closely depends on the advanced technologies for their identification, isolation, structure elucidation, and bioactivity evaluation. Additionally, this paper reviewed the novel trace compounds derived from Chinese herbal medicines which have been published in Organic Letters during 2001-2021, and summarized the important licensed drugs originated from the trace therapeutic substances and the discovery and development of trace therapeutic substances of 8 kinds of Chinese herbal medicines. This review provides references for the research and development of TCM therapeutic substances and innovative drugs.

International experience and enlightenment of short-term payment for innovative medical technology under the DRG payment / 中华医院管理杂志

China has entered the task stage of comprehensive medical insurance payment reform, but there are problems restricting the development of innovative medical technology in the reform of diagnosis-related groups(DRG) payment system. The author introduced the international definition and scope of innovative medical technology, and summarized the preconditions and payment policy of short-term payment of innovative medical technology under the DRG payment system; And put forward suggestions in line with China′s actual situation, including clarifying the definition of innovative medical technology, setting access conditions for additional payment or actual payment, setting up special transition funds for high-value innovative drugs, clarifying the payment amount of innovative medical technology, and formulating payment strategies for innovative medical technology.

Significance of a neglected tropical disease: lessons from a paradigmatic case of 'success in translation'

In a previous publication, I stressed the fundamental importance of research for improving health using as an example the control of Chagas disease in the Americas.(1) For that purpose, I analysed the major scientific breakthroughs and public health events from the 1909 discovery of Chagas disease and its causative pathogen, Trypanosoma cruzi, by Carlos Chagas,(2) through the successful control of its transmission by insect vectors in large regions of the Southern Cone countries in the 90s.(3) In the twenty years since that publication, Brazil and Latin American countries had to cope with a number of serious public health threats, old and new: (i) recrudescence of well-known diseases, such as dengue and yellow fever; (ii) emergence of viral diseases that had been restricted to other continents (Zika, Chikungunya); (iii) new epidemics (H1N1) or (iv) pandemics (COVID-19). Are there still some lessons from that success story against a neglected disease of the 90s that would be relevant today in the context of these recent challenges?

Registro sanitario de Heberprot-P®, medicamento biotecnológico innovador para el tratamiento de las úlceras del pie diabético / Sanitary registration of Heberprot-P®, an innovative biotechnological drug for the treatment of diabetic foot ulcers

Introducción: Heberprot-P® obtuvo su primer registro sanitario en Cuba en el año 2006, actualmente está aprobado en otros 26 países. Objetivo: Describir el proceso de registro sanitario en México, del medicamento biotecnológico Heberprot-P® para el tratamiento de las úlceras del pie diabético. Métodos: El proceso de registro sanitario de Heberprot-P® siguió las pautas de la reglamentación sanitaria de México sobre la base de la Ley general de salud y el Reglamento de insumos para la salud. Se revisaron además la Farmacopea de los Estados Unidos Mexicanos y las normas oficiales mexicanas en función de cumplir las exigencias para la comercialización de medicamentos en este territorio. Resultados: El proceso de registro se inició en junio de 2017 en México con acciones en función de completar los documentos e informaciones exigidas en el expediente de registro sanitario a presentarse. Entre ellos resaltan las consideraciones del Subcomité de Evaluación de Productos Biotecnológicos y el Comité de Moléculas Nuevas, la evaluación del expediente por un Tercero Autorizado y documentos emitidos por el Centro Nacional de Farmacovigilancia e Instituto Mexicano de la Propiedad Industrial. Se presentó la solicitud del registro sanitario ante Cofepris y esta se aprobó en mayo de 2018. Conclusiones: El trabajo con grupos de expertos permitió a la autoridad mexicana hacer un trabajo más expedito basado en las evidencias de las evaluaciones realizadas que son parte de la información del registro sanitario. Como resultado de este proceso, se otorgó el Registro Sanitario a Heberprot-P® en mayo de 2018 y Cofepris lo reconoció como un medicamento biotecnológico innovador(AU)

Introduction: Heberprot-P® obtained its first Sanitary Registration in Cuba in 2006, and it is currently approved in 26 other countries. Objective: Describe the sanitary registration process in Mexico of the biotechnological drug Heberprot-P® for the treatment of diabetic foot ulcers. Methods: The sanitary registration process of Heberprot-P® followed the guidelines of the sanitary regulations of Mexico on the basis of the General Health Law and the Regulation of Supplies for Health. The Pharmacopoeia of the United Mexican States and the official Mexican standards were also revised in order to comply with the requirements for the marketing of medicines in this territory. Results: The registration process began in June 2017 in Mexico with actions to complete the documents and information required in the sanitary registration file to be submitted. Among them are the considerations of the Sub-committee on the Evaluation of Biotechnological Products and the Committee on New Molecules, the evaluation of the file by an Authorized Third Party and documents issued by the National Center for Pharmacovigilance and the Mexican Institute of Industrial Property. The application for sanitary registration was submitted to Cofepris and this was approved in May 2018. Conclusions: The work with groups of experts allowed the Mexican authority to do a more expeditious work based on the evidence of the evaluations carried out that are part of the information of the sanitary registry. As a result of this process, Heberprot-P® was granted the Sanitary Registry in May 2018 and COFEPRIS recognized it as an innovative biotechnological medicine(AU)