Product Registration Research Articles

STRATEGI PENGEMBANGAN UMKM DENGAN PEMANFAATAN DIGITAL MARKETING DI ERA MODERNISASI (STUDI PADA UMKM LAMINGO97)

The rapid development of digital technology has an impact on the world of marketing. Digital marketing allows potential customers to obtain details regarding products and how to transact through internet media. So far, marketing carried out by lamingo97 has not utilized digital marketing, requiring consumers to come directly to available outlets to view products and make transactions in cash. This activity aims to assist Lamingo97 regarding the use of digital marketing as an MSME development strategy. The training and mentoring phase consists of several stages including (1) Introduction to packaging and branding, (2) logo printing on packaging (3) Product photos, (4) Introduction to social media and creating social media accounts, (5) Introduction to marketplaces and product registration on marketplaces such as Gofood. The results of the training and mentoring for UMKM Lamingo97 are: 1. UMKM Lamingo97 has a new packaging with a simpler and more attractive logo. 2. UMKM Lamingo97 has social media and a marketplace as marketing tools. 3. Business owners have the enthusiasm to develop their business, start actively participating in events and are,more confident because their products already have logos easily recognized by the public. 4. Business owners gain knowledge about social media and marketplace management procedures. 5. Business owners know the importance of digital marketing in advancing a business.

Could the Lung Be a Gateway for Amphotericin B to Attack the Army of Fungi?

Fungal diseases are a significant cause of morbidity and mortality worldwide, primarily affecting immunocompromised patients. Aspergillus, Pneumocystis, and Cryptococcus are opportunistic fungi and may cause severe lung disease. They can develop mechanisms to evade the host immune system and colonize or cause lung disease. Current fungal infection treatments constitute a few classes of antifungal drugs with significant fungi resistance development. Amphotericin B (AmB) has a broad-spectrum antifungal effect with a low incidence of resistance. However, AmB is a highly lipophilic antifungal with low solubility and permeability and is unstable in light, heat, and oxygen. Due to the difficulty of achieving adequate concentrations of AmB in the lung by intravenous administration and seeking to minimize adverse effects, nebulized AmB has been used. The pulmonary pathway has advantages such as its rapid onset of action, low metabolic activity at the site of action, ability to avoid first-pass hepatic metabolism, lower risk of adverse effects, and thin thickness of the alveolar epithelium. This paper presented different strategies for pulmonary AmB delivery, detailing the potential of nanoformulation and hoping to foster research in the field. Our finds indicate that despite an optimistic scenario for the pulmonary formulation of AmB based on the encouraging results discussed here, there is still no product registration on the FDA nor any clinical trial undergoing ClinicalTrial.gov.

Discussion on Key Attention in Technical Review for Additive Manufacturing Acetabular Reconstruction Implantable Device

With the development of additive manufacturing, the advantages of this type implant devices in the treatment of acetabular defects and reconstruction are becoming more and more prominent. The number of registration and declaration of such products is increasing day by day. According to the relevant requirements of the National Medical Products Administration for registration and application documents, combined with the characteristics of acetabular reconstruction implant products made of additive manufacturing, this study analyzes and summarizes the relevant requirements on raw material control, product performance research, product manufacturing, clinical evaluation, et al. We should pay more attention to in the registration and application materials submitted by the applicant. Provide opinions and suggestions for the next registration applicant to standardize product R&D and registration application documents, in order to help them optimize product R&D process, improve product quality and registration application efficiency.

Permissibility of the off-label use of a medicinal product in the context of a doctor’s liability – an attempt at clarification of the issue under the Polish law

Practising the profession of a doctor involves high social recognition but also entails responsibility for the health and life of a patient. In this context, pharmacological treatment applied in compliance with the formal registration of a medicinal product does not raise any serious concerns. However, it is not always possible to administer a medicine in a way that corresponds to its official characteristics. Clinical practice shows that it is often necessary to administer a medicine outside the requirements specified in the summary of product characteristics. In such cases, a legal, ethical and typically medical problem arises. The aim of the study is to analyse the entire legal environment of the doctors’ use of medicines outside the summary of product characteristics. The discussion leads to the conclusion that medical personnel are fully authorised to administer a medicinal product outside its official characteristics. However, this may only take place if such a decision is based on current knowledge, the doctor’s individual experience and acting in the best interest of the patient, as well as proper diagnosis of his/her current therapeutic needs. The legal regulations in force in Poland are sufficient in that sphere to ensure the well-being of the patient and protect the interests of the doctor, although – it should be admitted – their wording is not unambiguous enough to prevent more or less serious doubts as to their interpretation. Hence the proposal for legal clarification of the situation related to the administration of a medicine off-label.

Use of Antialergic Medicines: Application of the DDD Methodology in Real Practice

Currently, the increase in the number of allergic diseases is considered as a global problem in many countries, including Kyrgyzstan. According to WHO data, allergic diseases are currently ranked 4th among the major chronic diseases in the world. Pharmacotherapy occupies an important place in the treatment of allergy symptoms. To study the use of antiallergic drugs, namely antihistamine and glucocorticoid drugs in real practice, we used the DDD methodology. The aim of the study: to study the use of antiallergic drugs in real practice in the Kyrgyz Republic using the DDD methodology. Materials and research methods. The materials of the study were the data of the Department of Medicines and Medical Devices under the Ministry of Health of the Kyrgyz Republic on the registration of pharmaceutical products in the Kyrgyz Republic, price lists and invoices of wholesale pharmaceutical companies and retail pharmacies in Bishkek. Research results. At the time of the study, the pharmaceutical market of the Kyrgyz Republic has a balanced range of drugs, including 184 trade names of the above groups of drugs, namely 98 antihistamines and 86 glucocorticosteroids. The calculation of the degree of consumption of antiallergic drugs was presented as the number of established daily doses — the number of DDD (NDDD) sold in 2021. Conclusion. Analysis of the obtained data showed that the first place in terms of volume of consumption in natural terms among glucocorticosteroids are drugs containing dexamethasone — 4077 DDD, the second place is occupied by betamethasone — 953 DDD and the third fluticasone — 641 DDD. The leaders in terms of antihistamines consumption were Diphenhydramine — 15320 DDD, Fexofenadine — 3100 DDD and Loratadine — 683 DDD.

Analogous comparison of registered brand name drugs of tablets and capsules commercially available in Thailand: A retrospective study.

Drug name confusion or similar product packaging and labeling, also known as “look-alike, sound-alike” (LASA) medication error, is one of the most problematic causes of prescribing and dispensing errors. Therefore, this study aimed to compare the similarity of registered brand name drugs of tablets and capsules that are commercially available in Thailand to estimate the magnitude of LASA medication errors. Analogous comparisons of brand names using similarity in orthography (written forms with identical letters) were analyzed retrospectively. Tablets and capsules commercially available in Thailand and registered with the Bureau of Drug Administration, Food and Drug Administration (FDA) in 2012 as “dangerous drugs” and “specially controlled drugs” for humans and animals were included in this study. Descriptive statistics, including frequencies and percentages, were used in this study. The analogous comparison of brand name orthography was scrutinized, and the results revealed 1,668 brand names, which were categorized into three genres as follows:1) Single brand names from a single manufacturer having the same active pharmaceutical ingredient (API) with numerous registration numbers (1,049 names, 62.89% of the total similarity results)2) Single brand names from different manufacturers having the same API and possessing several registration numbers (615 names, 36.87% of the total similarity results)3) Single brand names from different manufacturers with diverse APIs (four brand names, 0.24% of the total similarity results).Analogous results revealed that numerous identical brand names could be derived from the same manufacturers, APIs, dosage strengths, or otherwise. The results of this study recommend improvement on product registration to better ensure patient safety in the future.

Estimating rates of pesticide usage from trends in herbicide, insecticide, and fungicide product registrations

Insecticides, herbicides, and fungicides are ubiquitously applied in agricultural production systems to increase yields by managing insect pests, weeds, and diseases. While valuable, these chemicals can also have unwanted off-target effects on human health, biodiversity, and resistance evolution. Pesticide usage data can help to estimate and mitigate these impacts, but many countries lack spatial data on chemical usage trends. In contrast to pesticide usage, data on pesticide registration are more widely available and often organised into structured databases in accordance with governmental regulatory requirements. Here, we explored the extent to which pesticide registration databases can infer patterns of usage across agricultural pesticides, based on United States (US) and Australian data. Our predictive models explained 56% and 38% of the variation in pesticide usage across the US and Australia, respectively, with pesticide registrations explaining 58% and 23% of this variation and the remainder explained by land use patterns. Our results show that pesticide registrations can help to infer usage patterns across different chemical groups, active ingredients, and agricultural regions. Increasing numbers of registered products, pests, and products for a given active ingredient were associated with increased usage. However, there remains unexplained variation in pesticide usage patterns between active ingredient groups, highlighting the importance of additional explanatory factors. The value of chemical registration databases could be further enhanced through registration against taxonomically-identified pest species, rather than relying on common names or broadly defined groups. The associations detected in our work could be used to improve estimates of pesticide usage in countries lacking reliable data.

The 4P telehealth business framework for Iran

BackgroundTelehealth services can utilize various information technologies and improve quality and efficiency of healthcare delivery by facilitating education, treatment, follow-up, and decision-making. However, these services are not always commercialized, and in case of commercialization, there is no guarantee for their long-term sustainability in market. Therefore, business models and frameworks are used as part of commercialization processes to identify a set of factors affecting the sustainability, effectiveness, and key business activities. The current study aimed to develop a telehealth business framework for Iran.MethodsThis research was conducted in 2021, and a mixed-methods approach was used for data collection. Initially, a telehealth business framework was developed based on the findings derived from a systematic review and a qualitative research. The proposed framework was then reviewed by an expert panel (n = 9) in which the participants had at least three years of work experience in telehealth. Finally, the framework was validated using the Delphi method (three rounds).ResultsThe expert panel believed that some components such as partners’ expertise, required capital and financial resources, research and analysis, marketing and branding, tax, product registration, and marketing at scientific congresses and science and technology exhibitions needed to be added to the framework. In the Delphi study, 68 out of 74 components proposed in the initial framework were approved across four major dimensions; namely, prerequisites, production, payments and costs, and post-production services.ConclusionsIt seems that the developed framework can facilitate commercializing telehealth technologies and developing business plans. In addition, telehealth start-ups can use this framework and its various components in a competitive market to be more successful in their businesses. However, it is still critical to evaluate the effectiveness of the framework in practice and in relation to the commercialization of telehealth technologies.

Supply Chain Assessment of Maternal, Newborn and Child Health Commodities in Ghana’s Private Sector Facilities, Wholesalers, and Retail Pharmacies

Background: The private sector in Ghana provides 50% of health services in the country yet there is limited information on the supply chain management of MNCH commodities in this sector. Aim: To understand how MNCH commodities are managed within the private sector. Method: A mixed methods approach was used to capture supply chain related data on a subset of MNCH commodities in the private sector. The sampling strategy included the selection of four regions (Ashanti, Greater Accra, Northern, and Upper East) in Ghana. Quantitative data on product management, availability, source, pricing and registration were collected from retail pharmacies, private health facilities and wholesalers. Additionally qualitative data on factors influencing supply decisions were collected from wholesalers. Results: The study showed that retail pharmacies and wholesalers were less likely to manage injectable products like gentamicin, magnesium sulphate and oxytocin as compared to private health facilities. At all three facility types, amoxicillin DT, chlorhexidine gel and ORS + zinc co-pack were the least managed products. The main reason for non-management of MNCH products was “low or no client demand”. Majority of MNCH products had at least half of the most prevalent brands registered. Regarding product pricing, the results showed lower NHIS prices for certain products compared to selling prices at retail pharmacies and health facilities. Ninety percent of all three facility types met at least half of the storage requirements; with 100% of wholesalers and 96% of health facilities storing oxytocin in a working refrigerator. However, 25% of retail pharmacies did not store oxytocin within the recommended temperature range of 2-8 degrees. Conclusion: The private sector is influenced by commercial factors, which could come at a high cost in terms of availability, accessibility, and affordability for individuals and families. There is the need to create a cost incentive that encourages the private sector to offer and improve access to critical MNCH commodities, including amoxicillin DT, ORS + zinc co-pack, chlorhexidine gel and injectable MNCH products. Keywords: Private sector, MNCH, Supply Chain, Wholesale pharmacies, Retail pharmacies

Drug Development Process: Nonclinical Development of Small-Molecule Drugs

This article provides a high-level overview of the drug development process of small-molecule drugs for the analytical chemist. Emphasis is given to the nonclinical development and roles of the technical development organization in driving the new drug development project from toxicology studies to new product registration. A case study of the career path of a separation scientist is used to illustrate the diversified roles of an analytical chemist in drug development.

Efficiency of serum application for prevention and treatment of cattle

The possibility of using serum against pasteurellosis, salmonellosis, escherichiosis, parainfluenza type 3, and infectious bovine rhinotracheitis has been investigated and proven. The stability of production processes in the manufacture of the drug is shown. It has been established that the use of serum in treatment or prevention enhances specific immunity and contributed to the safety of animal population. Serum against pasteurellosis, salmonellosis, escherichiosis, parainfluenza type 3, and infectious bovine rhinotracheitis is a solution for injection. The search for new drugs for the prevention and treatment of farm animals is an urgent task. For veterinary medicinal products, not only high immunogenicity and active protection against diseases are fundamental importance, but also low cost. Only with the economically affordable and sufficiently efficient sera, the possibility of preventing the spread of diseases is realized. Considering the economic component variety of polyvalent antigens for serum production is is significantly reduced. The possibility of using serum against pasteurellosis, salmonellosis, escherichiosis, parainfluenza type 3, and infectious bovine rhinotracheitis has been investigated and proven. The serum is safe, has preventive and therapeutic properties. Medicinal product, namely, Serum against pasteurellosis, salmonellosis, escherichiosis, parainfluenza type 3, infectious bovine rhinotracheitis is registered by the The Federal Service for Veterinary and Phytosanitary Supervision in Register of medicinal products for veterinary use, registered in the Russian Federation. Number of the registered certificate of the medicinal product for veterinary use 02-1-35.13-2309 №ПВР - 1-1.5/02079.

Regulatory requirement for the approval of Generic Drug in Vietnam as per ASEAN Common Technical Dossier (ACTD)

Drug approval process differs from one country to another country. The purpose of this study is to give a comparative overview on generic drug market regulation in ASEAN Countries Cambodia and Vietnam. The aim of study is to facilitate proper knowledge regarding main critical issues, differences as well as similarities of related drug regulation. There is a different requirement for registration of generic product in each regulatory system but also comprises of some similar outline that includes some common rules. These are variances and regulatory hurdles such as Number of batches for submission in dossier, stability conditions, registration of product, analysis, bioequivalence and clinical study requirement. ASEAN countries for generic drug product approval ACTD submitted to country specific authority. For solid oral dosage forms as per ASEAN guideline there are 4 parts have to be submitted. Part I contains Administrative requirements which is not a part of common technical document. Part II is Quality contains 3 sections that are a) Table of Content b) Quality overall Summary c) Body of data. Part III contains Non clinical. Part IV contains Clinical data. For the generic drug product Part III and Part IV is not required.

Comparison of Dietary Supplements Product Registration requirements in Singapore, Malaysia, Ghana, Zimbabwe and India

Nowadays, diet is thought to be much richer than it used to be. The people’s ignorance of the basic principles of nutrition has led a large part of the population to a non-balanced diet that is high in both calories and fat and low in proteins, vitamins and minerals. This is where Dietary supplement comes in role as it is any vitamin, mineral, herbal product, or other ingestible preparation that is added to the diet to benefit health. Dietary supplements are used worldwide and represent a broad category of ingestible products that are distinguishable from conventional foods and drugs. They do not belong to the category of common food neither medicines nor special dietary products and not intended for specific categories of people. It is very important to ensure that any product entering the market completely complies with the regulatory guidelines and requirements. The regulation of dietary supplement in the five countries India, Singapore, Malaysia, Ghana and Zimbabwe is reviewed and compared.

Compressive Review on Role of ICH Guidelines in Registration of Pharmaceutical Products

The International Conference On Harmonization (ICH) Of Technical Requirements Is A Unique Project For Registration Of Pharmaceutical Products Which Are Intended For Human Use. This Brings Together The Regulatory Authorities Of Europe, Japan And United States And Experts From The Pharmaceutical Industry In The Three Regions To Discuss Scientific And Technical Aspects Of Product Registration.The Purpose Is To Make Recommendations On Ways To Achieve Greater Harmonization In The Interpretation And Application Of Technical Guidelines And Requirements For Product Registration In Order To Reduce Or Obviate The Need To Duplicate The Testing Carried Out During The Research And Development Of New Medicines.The Objective Of Such Harmonization Is A More Economical Use Of Human, Animal And Material Resources And The Elimination Of Unnecessary Delay In The Global Development And Availability Of New Medicines Whilst Maintaining Safe Guards On Quality, Safety And Efficacy And Regulatory Obligations To Protect Public Health. It Creates A Venue That Allows All Key Pharmaceutical Regulatory Authorities And Industry Stakeholders The Opportunity To Be More Actively Involved In Pharmaceutical Harmonization Work. It Aimed At The Standardization Of Requirements And Format Along With The Content Of Regulatory Documentation And Brings Down The Pressure On The Price Of Medicines By Enabling Greater Economies Of Scale And A Labelled Regulatory Playing Field. This Paper Is An Effort To Provide The Detailed Information About ICH Guidelines. Keywords: International Conference On Harmonization, Product Registration, Medicines, Pharmaceutical

Lessons Learned from the Development and Roll-Out of the rVSVΔG-ZEBOV-GP Zaire ebolavirus Vaccine to Inform Marburg Virus and Sudan ebolavirus Vaccines.

This review describes key aspects of the development of the rVSVΔG-ZEBOV-GP Ebola vaccine and key activities which are continuing to further expand our knowledge of the product. Extensive partnerships and innovative approaches were used to address the various challenges encountered during this process. The rVSVΔG-ZEBOV-GP Ebola vaccine was initially approved by the European Medicines Agency and prequalified by the World Health Organization in November 2019. It was approved by the United States Food and Drug Administration in December 2019 and approved in five African countries within 90 days of prequalification. The development resulted in the first stockpile of a registered Ebola vaccine that is available to support outbreak response. This also provides insights into how the example of rVSVΔG-ZEBOV-GP can inform the development of vaccines for Sudan ebolavirus, Marburg virus, and other emerging epidemic diseases in terms of the types of approaches and data needed to support product registration, availability, and the use of a filovirus vaccine.

Challenges and Opportunities of the Ugandan Traditional Herbal Medicine Sector

The use of herbal medicine products worldwide and in Uganda is on the rise and there is much-renewed interest in their use because of the belief that they are safe. However, this belief is not backed up by credible scientific research for many products in Uganda. Almost all herbal products produced locally in Uganda have no scientific proof for their claimed safety and efficacy for the treatment of the various conditions they are claimed to treat example; covid-19, HIV, hypertension, erectile dysfunction, and others. There is an urgent need to quickly improve and enforced research on the local products in order to realise the economic benefits which could be lying hidden in them and put a ban on adulterated products from being sold to the public. This review was conducted in order to determine the challenges and opportunities in the Traditional Herbal Medicine sector in Uganda. It was found out that enormous challenges face the Traditional Medicine sector in Uganda including; lack of research on products available for use, claims of one product treating multiple conditions, adulteration of products with established Pharmaceutical drugs and no stringent regulations on registration of products. However, a lot of opportunities were also noted available for exploitation to develop the sector further. Collaboration with local Universities to speed up research using the Reverse Pharmacology approach [1] on the available products, strictly enforcing regulation on product registration and exploiting the reverse Pharmacology approach to study the local products, aggressive and intentional investment in basic research infrastructures and speeding up Clinical Trials on products found to be safe and effective could allow the realisation of the benefits which could be hidden in the local Traditional Medicine products.

Consideration on Animal Experiment in PET/CT

PET/CT imaging can reflect the physiological metabolic process in living body which is the model experiment incapable to simulate. Animal experiment may be considered for systematic validation of PET/CT products. The obtained research data can be used to evaluate the feasibility, effectiveness and safety of PET/CT products, and be submitted as supporting documents for research data or clinical evaluation data when doing product registration or alteration registration. In this study, the functions and advantages of animal experiments were expounded, and relevant research cases were given as well as the issues that should be paid attention to. It can be a reference for the validation and review of PET/CT products.

The Training of Trademark Registration for Usaha Mikro Kecil Menengah (UMKM) to Protect Hak Kekayaan Intelektual (HKI)

The training trademark registration were important to support the development of a business product. Several members of Fatayat NU Batanghari have businesses that produced many products of economic value. The limited knowledge people was about trademarks of products did not have brand. Hence, the purpose of this article was to increase knowledge about trademark registration and the process of registered trademarks at the Direktorat Jendral Kekayaan Intelektual (DJKI). The method used Community Based Research (CBR) with 50 participants of PAC Fatayat NU Group of Bumiharjo Village, Batanghari East Lampung. The collecting data used observation, documentation and conducting Forum Group Discussion (FGD). Furthermore, the result product have a legitimate brand. Hence, it has a high economic value and avoids plagiarism by irresponsible people. This Community Service used the Community Based Research (CBR) method and the sample was 50 participants. The result of this service community showed that the participants could engage their knowledge about the importance of legally registering business product trademarks. Especially Fatayat NU Batanghari group  got the rights from the trademark registration of thier business product.
 Keywords: Training Trademark Registration, Hak Kekayaan Intelektual, Registration of UMKM

Brazil's Regulatory Context for Using New Approach Methodologies (NAMs) on the Registration of Products.

New Approach Methodologies (NAMs) are any non-animal-based approaches that can provide information in the context of chemical hazard and safety assessment. The goal is to develop information with equivalent or better scientific quality and relevance than that provided by traditional animal models. Starting with ethical issues, these approaches are gaining regulatory relevance in different global agencies. Since 2008, with the enactment of the Arouca Law—the first Brazilian legislation dedicated to laboratory animals, NAMs are gathering pace in Brazil’s regulations. Specific regulations from different sectors include the acceptance of these new methods. However, some regulation is controversial about what is needed to address specific toxicological endpoints. The resulting regulatory uncertainty induces companies to keep on adopting the traditional methods, slowing NAM’s development in the country. This work brings a perspective on the regulatory acceptance of NAMs in Brazilian Legislation for the registration of pharmaceuticals, medical devices, food/supplements, and agrochemical products. This text discusses the main issues of NAM adoption for each specific regulation. Therefore, legal acceptance of NAMs results in Brazil is still a process in progress. A collective effort including regulators, industry, contract research organizations (CROs), and the academic environment is needed to build regulatory confidence in the use of NAMs.

Preservatives in non-cosmetic products: Increasing human exposure requires action for protection of health.

The widespread use of skin sensitizing preservatives is well-known. Contact allergy to preservatives is often caused by their presence in cosmetic products. Preservative use in non-cosmetic products is less well-known. We have reviewed European Union (EU) legislations on classification and labelling, biocides and cosmetics, concerning conditions for use of the most used sensitizing preservatives (including formaldehyde-releasing substances, isothiazolinones and parabens). We have analysed temporal trends in their use in non-cosmetic products (tonnes, number of products, concentrations), based on annual reports to the Swedish Products Register 1995-2018; and we discuss implications for stakeholders. Major changes over time are that the use of most of the preservatives has increased by tonnes and/or by number of products, and that several use concentrations have declined following harmonized classification as a skin sensitizer with low concentration limits for this classification. We conclude that the massive increase in use of preservatives is alarming, and that urgent action is needed for protection of health. Their use in non-cosmetic products is broad, increasing and often undisclosed. In the EU, legislations concerning chemicals can provide relevant restrictions to reduce their use and associated health risks, monitored by efficient surveillance. Prevention would be benefited by better coordination between legislations.