OBJECTIVES

This study aimed to identify problems and highlight opportunities for pharmaceutical sciences research in the Philippine pharmaceutical industry's regulatory and clinical research sectors that might have been previously overlooked or underrepresented. It identified current issues that can be addressed by research covering four areas of pharmaceutical sciences: drug design and discovery, pharmacokinetic/pharmacodynamic studies, formulation design and pharmaceutical technology, and regulatory science.

A descriptive qualitative approach was used in this study. Data collection was facilitated by key informant interviews (KII) using a standardized interview guide with open-ended questions to identify the pharmaceutical science research needs of the specific sectors. A purposive sampling method was employed, with five key informants (KIs), including the company vice president, director, and top-level managers from different local and multinational pharmaceutical companies. ATLAS.ti software was utilized to facilitate thematic synthesis for qualitative data analysis.

Thirteen common themes were identified from the KIs, such as (1) incomplete development of therapeutic compounds, (2) sustainability of raw materials supply, (3) regulation of herbal medicines versus food supplements, (4) mapping disease priorities through the Philippine pharmaceutical roadmap, (5) government incentives and policies to support research, (6) technical personnel, (7) suboptimal regulatory process, approvals, and implementation, (8) gap in utilization of acquired knowledge on regulations, (9) regulatory governance, (10) passive regulatory action on counterfeit drugs, (11) PIC/S GMP version 14 adaption, (12) formulation optimization, and (13) active pharmaceutical ingredient (API) sourcing and regulation. Based on insights from the International Pharmaceutical Federation regarding anticipated hurdles in pharmaceutical sciences over the next 5-10 years, priority research needs were identified through KIs' input. Relevant action plans were developed, including the creation of research proposals to isolate, purify, and determine chemical structures of natural products, as well as analyzing recent Philippine Health Statistics to help assess the appropriateness of new drug releases for patient needs. Other action plans include forecasting future disease burdens in the country, performing toxicology studies (Health-Based Evaluation Levels/No Observed Adverse Effect Level or HBEL/NOAEL) for common generic drugs, and ensuring that research efforts are directed toward addressing the Philippine pharmaceutical regulatory and clinical research sector's most pressing needs practically and feasibly.

This study offers valuable insights into pharmaceutical sciences research and development initiatives within the regulatory and clinical research sectors in the Philippine pharmaceutical industry. These findings have the potential to catalyze transformative advancements in healthcare delivery and outcomes, positioning the Philippines for global excellence and competitiveness.

This study systematically analyzed the global research landscape, technological composition, and core patents in the field of networks target and network pharmacology, and proposes further suggestions based on the IncoPat patent citation database and VOSviewer bibliometric network visualization tool. Using patent literature metrics and scientific knowledge mapping method, technological innovation pathways, research hotspots, and future directions in this field were further revealed. In particular, this field is moving towards data-driven, intelligent, and systematic approaches. Patent analysis indicated that most patent applications in this domain focused on traditional Chinese medicine(TCM), which have provided key engineering technical approaches to explore and solve complex problems of TCM. By integrating big data and artificial intelligence technologies, network targets and network pharmacology have conferred high-precision screening and quality control of key components and targets in herbal formulations and prescriptions, accelerating the clinical translation and industrialization of TCM-based new drugs and health products with medicine-food homology. Therefore, it is essential to optimize the patent protection system and establish integrated technology platforms in this field for ensuring the competitiveness of technological achievements in research and clinical application. These efforts will advance the widespread application and high-quality development of TCM modernization, precision medicine, and innovative drug discovery.
Bibliometrics ; Patents as Topic ; Humans ; Medicine, Chinese Traditional ; Network Pharmacology/trends* ; Drugs, Chinese Herbal/pharmacology*

Endangered Chinese medicinal materials have a wide range of applications and play an indispensable role in the system of traditional Chinese medicine(TCM). The protection of these endangered medicinal materials has always been a crucial task in the development of TCM. This paper systematically reviewed the changes in regulatory bodies for the protection of endangered Chinese medicinal materials and their related management policies since 1949, and conducted an in-depth discussion of the current laws and regulations governing the protection of endangered Chinese medicinal materials. At the same time, the paper comprehensively organized the current situation of endangered Chinese medicinal material protection in China, analyzed its causes, pointed out deficiencies in the current protective measures, and proposed countermeasures and suggestions for improvement, with the aim of providing references and guidance for the sustainable development of Chinese medicinal materials. Through this review, the paper aimed to raise public and governmental awareness of the importance of protecting endangered Chinese medicinal materials, thereby promoting the sustainable and healthy development of TCM. Additionally, the paper hopes to provide ideas for the formulation and implementation of relevant policies and contribute to the further improvement and deepening of the protection efforts for endangered Chinese medicinal materials.
Drugs, Chinese Herbal/analysis* ; China ; Endangered Species/legislation & jurisprudence* ; Medicine, Chinese Traditional ; Plants, Medicinal/chemistry* ; Conservation of Natural Resources/legislation & jurisprudence* ; Humans

The emergence of new-generation artificial intelligence technology has brought numerous innovations to the healthcare field, including telemedicine and intelligent care. However, the artificial intelligent medical device sector still faces significant challenges, such as data privacy protection and algorithm reliability. This study, based on invention patent analysis, revealed the technological innovation trends in the field of artificial intelligent medical devices from aspects such as patent application time trends, hot topics, regional distribution, and innovation players. The results showed that global invention patent applications had remained active, with technological innovations primarily focused on medical image processing, physiological signal processing, surgical robots, brain-computer interfaces, and intelligent physiological parameter monitoring technologies. The United States and China led the world in the number of invention patent applications. Major international medical device giants, such as Philips, Siemens, General Electric, and Medtronic, were at the forefront of global technological innovation, with significant advantages in patent application volumes and international market presence. Chinese universities and research institutes, such as Zhejiang University, Tianjin University, and the Shenzhen Institute of Advanced Technology, had demonstrated notable technological innovation, with a relatively high number of patent applications. However, their overseas market expansion remained limited. This study provides a comprehensive overview of the technological innovation trends in the artificial intelligent medical device field and offers valuable information support for industry development from an informatics perspective.
Artificial Intelligence ; Patents as Topic ; Humans ; Inventions ; China ; Brain-Computer Interfaces ; Telemedicine ; Equipment and Supplies ; Robotics ; Algorithms

Amid the global wave of digital economy, China's medical artificial intelligence applications are rapidly advancing through technological innovation and policy support, while facing multifaceted evaluation and regulatory challenges. The dynamic algorithm evolution undermines the consistency of assessment criteria, multimodal systems lack unified evaluation metrics, and conflicts persist between data sharing and privacy protection. To address these issues, the China National Health Development Research Center has established a value assessment framework for artificial intelligence medical technologies, formulated the country's first technical guideline for clinical evaluation, and validated their practicality through scenario-based pilot studies. Furthermore, this paper proposes introducing a "regulatory sandbox" model to test technical compliance in controlled environments, thereby balancing innovation incentives with risk governance.
Artificial Intelligence/legislation & jurisprudence* ; China ; Humans ; Algorithms

In China, the regulatory framework for medical device procurement and sales, particularly concerning anti-commercial bribery, relies heavily on punitive mechanisms applied after violations occur. Consequently, there is an urgent need to establish a scientific risk regulation framework as a complementary approach. Effective risk-oriented regulatory models require precise identification of risk areas in commercial bribery. Focusing on several major procurement scenarios such as centralized bulk-buying, tendering and bidding processes, in-hospital procurement, and online purchasing, this article analyzes the structural factors contributing to these risks, represented by the absence of certification mechanisms, lack of transparency in information disclosure, and inadequate checks and balances. Based on official risk assessment results, this study applies the theory of power and responsibility to propose a preventive regulatory framework that combines industry self-discipline and administrative oversight. By combining these approaches, the framework aims to develop regulatory measures that can effectively reduce commercial bribery risks and prevent illegal and non-compliant conduct.
China ; Equipment and Supplies/economics* ; Commerce/legislation & jurisprudence* ; Humans ; Risk Assessment

BACKGROUND

The Philippines implemented a law on the inclusion of graphic health warning (GHW) labels in cigarette packs to increase awareness about the health effects of smoking, to quit smoking, or to deter potential users from engaging in cigarettes. Investigating its impact on senior high school (SHS) students may provide insights into enhancing and reinforcing the law to achieve its purpose at the adolescent developmental stage.

The objective of this study was to determine the perceived emotional and cognitive reactions as well as the perceived health risks of GHWs among nonsmoking SHS students in Leyte and their relationship to their level of exposure.

A cross-sectional design was employed involving 247 students from public high schools in Pastrana, Leyte, who were selected through stratified random sampling. A self-report questionnaire was used to gather the data. Spearman’s rho correlation coefficient was used to test the hypothesis.

The majority of the participants reported positive perceptions of GHW labels. Moreover, the majority of them have seen GHW at least once a week on cigarette packs and evoked variable agreement about the high arousal and low arousal negative emotion, but have positive cognitive reactions. They have a strong agreement on the perceived health risks posed by cigarette smoking through GHWs. There was a positive and significant correlation between the level of exposure and the perceived health risks of smoking through the GHWs.

Adolescent learners reported variable agreement on emotional reactions, but had positive cognitive reactions to tobacco GHW labels. They also have reported that GHWs in cigarette packs provide positive visual information on the health effects and other consequences of smoking. Those who have frequent exposure to the GHWs of the cigarette packs were more likely to report knowledge and information on the health risks of smoking. Thus, the GHWs on cigarette packs are still necessary to decrease the new smoker rate, especially among adolescents. Policy implications toward the continuous development of GHWS are offered.

OBJECTIVE: To discuss the development status of meridian diagnosis technology through the patent analysis, so as to obtain the hot spots of patents and provide the ideas for the research and development of new equipment. METHODS: The patent data of meridian diagnosis technology were searched from Chinese Think Tank of Traditional Chinese Medicine. The patent analysis and SWOT method were used to deeply explore the patent application of meridian diagnosis technology. RESULTS: Among 100 patents included, the inventions were mainly in Chinese mainland, and the invention institution was from Chengdu University of TCM. Since 2015, the number of patent application for meridian diagnosis technology was increasing, and up to a peak from 2020 to 2021. The main technological programs cover electrical, temperature and optical detection; and the application functions focus on the precise positioning of acupoints, and the diagnosis of zangfu diseases. CONCLUSION From the perspective of patents, it is suggested that the development of meridian diagnosis technology in China should pay attention to reducing the cost, improving the function, driving the standard formulation, strengthening safety measure, deepening human-machine interaction, exploring biological effect and optimizing the experimental platform. Through continuous innovation and breakthrough, the meridian diagnosis technology can be further matured and widely applied, so as to realize its comprehensive upgrade.
Meridians ; Humans ; Patents as Topic ; Medicine, Chinese Traditional/instrumentation* ; China ; Acupuncture Points

OBJECTIVE: To reveal the research status of fire needle by analyzing its patent applications, so as to provide reference for the development of fire needle equipment and the promotion of this therapy. METHODS: By searching the incoPat global patent database, from its inception to December 29th, 2024, the patent data on fire needle was collected. The patent analysis was employed on patent application trends, geographical distribution, patent types, current legal status, applicants and inventors, overall technical composition and distribution of applicable diseases. With the help of incoPat's "shared value" evaluation model, the technical efficacy value of patent was comprehensively measured from 3 dimensions, i.e. technical stability, technological advancement and protection scope. Using SWOT analysis, the matrix of strengths, weaknesses, opportunities and threats of fire needle technique was constructed, and then its development trend was analyzed systematically. RESULTS: A total of 346 patents were included, comprising 23 granted invention patents (6.65%), 219 utility model patents (63.29%), and 157 patents were in an effective state of validity (45.38%). The number of fire needle patent applications showed a growing trend since 2013 and peaked in 2021. The top 3 provinces and cities in terms of the number of applications were Guangdong, Beijing and Shandong. Existing patents focus on improving convenience, reducing complexity, enhancing safety and increasing efficiency; and are specialized in treatment of dermatological diseases. The results of patent research on fire needle show the application of updated materials, invention of equipment and expansion of applicable diseases. However, there are still some limitations such as technical complexity, high cost, lack of composite talents, lack of awareness of patent maintenance and insufficient international promotion. CONCLUSION Multiple strategies are proposed on the development of fire needle therapy, i.e. enhancing financial support and expanding the number of diseases, giving full play to regional characteristics and advantages to promote resource sharing, deepening the integration of industry, research and education to improve the quality of patents, strengthening supervision to reduce low-quality patents, and carrying out high-level research to promote technical standardization and internationalization, and enhance global competitiveness.
Patents as Topic ; Humans ; Acupuncture Therapy/methods* ; Needles ; China

Advance medical directives allow patients to plan in advance their medical decisions in the event of incurable diseases or at the end of their lives when they have the capacity to make such decisions.This institutional design not only breaks through the traditional medical decision-making model and enables patients to make autonomous decisions across time and space,but also demonstrates the law's respect for and protection of patients' right to make autonomous decisions and their dignity of life.The Hong Kong Special Administrative Region submitted the bill related to advance medical directives to the Legislative Council for review at the end of 2023.On November 20,2024,the Advance Decision on Life-Sustaining Treatment Bill was passed,a move that is of great significance to regulating the legal issues in medical decision-making.This paper will delve into the basic principles,main contents,and related considerations of advance medical directives in Hong Kong,aiming to provide insights and references for the future improvement of relevant laws in the Chinese mainland.
Hong Kong ; Advance Directives/legislation & jurisprudence* ; Humans ; Decision Making