Product Registration Research Articles

17-Hydroxyprogesterone caproate: cancellation of product registration in Malaysia

17-Hydroxyprogesterone caproate: cancellation of product registration in Malaysia

International Approaches to the Development, Validation, and Change Management of Analytical Procedures (Review)

INTRODUCTION. In 2023, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published a new Guideline on Analytical Procedure Development (ICH Q14) and a revised version of the Guideline on Validation of Analytical Procedures (ICH Q2(R2)). Consequently, there is a need for a considerable revision of the approach to the development and validation of analytical procedures that is currently used in the Eurasian Economic Union (EAEU). A revision is also needed for the processes for evaluating and introducing variations to the analytical procedures described in medicinal product registration dossiers.AIM. This review aimed to analyse the significant changes made to international approaches to the development of analytical procedures, as well as to study the advantages and disadvantages of these approaches for pharmaceutical manufacturers and regulatory agencies in the EAEU.DISCUSSION. This review covers the key provisions and practical aspects of the enhanced approaches to the development of analytical procedures introduced by the ICH Q14 guideline. In particular, the review addresses the concepts of the analytical procedure life cycle (APLC) and the modified analytical qualityby-design (AQbD) approach; the development of the analytical target profile (ATP); analytical quality risk management; planning of the design of experiments (DoE) and the analytical procedure control strategy; and the validation, subsequent verification, transfer, and change management of analytical procedures. Additionally, the review describes the ICH Q2(R2) updates that accompany this new regulatory paradigm.CONCLUSIONS. The above guidelines fill the existing gap in recommendations for the development of analytical procedures. The use of the APLC and AQbD concepts provides both pharmaceutical companies and regulatory authorities with flexible approaches that are applicable to analytical procedures both during the development phase and once they have been implemented. Effective implementation of these international approaches in the Russian pharmaceutical industry and regulatory system requires a broad discussion between pharmaceutical industry professionals and regulatory agency experts, possibly, as part of a pilot project. After that, there will be a necessity to provide training for specialists involved in the development of analytical procedures and to amend the EAEU Rules for Marketing Authorisation and Expert Assessment of Medicinal Products for Human Use.

Veterinary Evidence: moving forward

Unrecognised and unknown information needs can significantly impact on the quality of decision making, advice, and patient care. In the practice of veterinary medicine, additional information may be required in one or more of epidemiology, diagnosis, treatment, prognosis, control (risk reduction), and prevention (risk avoidance), in order to optimise patient care. Veterinary Evidence publishes Knowledge Summaries, which aim to answer a specific and focused clinical query by appraising the best available evidence published in peer-reviewed scientific journals. By presenting the evidence in a structured and easily digestible format, Knowledge Summaries enable veterinary professionals to stay informed and apply the best available evidence to their decision-making. To assist in the identification of unrecognised deficits and the generation of clinical queries Veterinary Evidence has developed a list of common conditions for each species, alongside the different categories of information. The aim is to prompt and support the generation of new clinical queries in a more systematic format. This resource sits alongside our species-based lists of clinical queries that have already been suggested by practicing veterinarians, veterinary nurses, and other paraprofessionals (see veterinaryevidence.org/index.php/ve/clinical-queries). We hope readers and prospective authors will use these resources to generate new clinical queries or as a starting point for writing their own Knowledge Summaries. Most of the papers published in Veterinary Evidence are Knowledge Summaries, but the journal has always accepted and will continue to accept and encourage other types of reviews and original research that provide evidence to inform clinical practice. For example, in this issue we have published a commentary paper by Professor Jonathan Elliott regarding the processes and evidence required for the registration of veterinary medicinal products which provides some important insights and debate into the publication of evidential information (Elliott, 2024). A Knowledge Summary may not always be the best format to synthesise and summarise evidence on a multifaceted topic; scoping reviews, systematic reviews, or narrative reviews maybe more appropriate. Munn et al. (2018) provide a useful account of scoping reviews and how they differ from traditional literature and systematic reviews. In particular, we are keen to receive articles on artificial intelligence applications, sustainability, and quality improvement in clinical practice, as the impact and importance of these topics grows. We are also making some changes to the presentation of Knowledge Summaries in Veterinary Evidence, to help readers more easily understand the details and context of the summarised evidence. In order to support everyone in appraising and understanding quantitative clinical studies, we will be publishing a glossary and guidance on basic statistical terms and tests on the journal website.

A Review on a Drug Registration Process in United Kingdom

This review outlines the regulatory modifications in several pharmaceutical industries that have been impacted by Brexit and develops new standards-based recommendations from the Medicines and Healthcare Products Regulatory Agency (MHRA). To get insight into the regulatory changes that occurred in the pharmaceutical industry during the dissolution of Europe and Britain, retrospective and contemporaneous reviews were used. As the transition period concluded, the MHRA issued a library of new guidelines on January 1, 2021. The several pharmaceutical industries covered by this guidance include clinical trials, medical equipment, imports and exports of Pharmaceuticals and Cosmetics. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for approving medicinal products in the UK. The agency offers various routes for marketing authorisation, including national, international, and decentralised procedures. The national routes include a 150-day assessment, rolling review, European Commission (EC) Decision Reliance Procedure, decentralised and mutual recognition reliance procedure, and unfettered access procedure for marketing authorisations approved in Northern Ireland. International routes include Project Orbis and Access Consortium. Applicants must submit their applications through the MHRA submissions portal in electronic Common Technical Document (eCTD) format. The agency verifies the technical validity of submissions using the Lorenz Docubridge validation tool. The MHRA offers fast-track marketing authorisation for products with strong public health benefits or those addressing supply shortages. Applications that do not meet guidelines will be rejected, and applicants must resubmit after correcting errors. Understanding MHRA guidelines and requirements facilitates market entry for medicinal products in the UK. Conclusion: Any medicinal agent to be marked in the United Kingdom has to follow the guidelines and regulations given by the MHRA a regulatory authority which approve drug products. The objective of the review article is to highlights information regarding the requirements. Different types routes in registration of medicinal products in a market in the United Kingdom knowing the requirements of the MHRA guidelines, it is too easy for a product to get into the UK market.

Technological sovereignty is a priority of the transport policy of the Russian Federation in the context of external sanctions

The technological sovereignty of our country in the face of external sanctions is impossible without a purposeful state policy in its main areas, including transport. The article considers the objectives of transport policy to achieve technological sovereignty in the transport complex in the modern geopolitical situation. The author analyzed the main documents that define the state strategy for ensuring technological sovereignty. Currently, government agencies are very effectively solving these tasks together with state corporations, in particular, together with Russian Railways. Today, the holding implements innovative partnerships, concludes international agreements on cooperation in the field of transport construction with friendly countries and is a leader in the number of certificates of state registration of software and other innovative products received. In the course of the analysis of the innovative activity of JSC «Russian Railways», the possibilities of state corporations for solving the tasks of ensuring the technological sovereignty of Russia are revealed. To do this, it is necessary to actively develop science, create the necessary institutional conditions, as well as provide state support in the field of financing priority areas and projects, forming forms of economic participation of the state in the work of transport companies on the basis of equal partnership. the author comes to the conclusion that the basis of the innovation strategy JSC «Russian Railways» today is a comprehensive program for the development of the holding and an information technology development program. The holding's experience as a state corporation shows that such business associations are largely capable and ready to solve the main tasks of ensuring the technological sovereignty of the country.

Analysis of problems and management of in vitro diagnostic reagent clinical trials in medical laboratory

Clinical trials are an important method for evaluating the safety and efficacy of in vitro diagnostic reagents, and are a key basis for product registration review and approval. In order to strengthen the management of clinical trials of in vitro diagnostic reagents, the National Medical Products Administration and relevant departments have formulated a series of regulations at the regulatory level, and require applicants and clinical trial institutions to establish a quality management system for clinical trials of in vitro diagnostic reagents. Medical laboratory is the main department and implementer of in vitro diagnostic reagent clinical trials in medical institutions. In recent years, with the rapid development of the in vitro diagnostic industry, the clinical trial projects of in vitro diagnostic reagents conducted by medical laboratory have been increasing day by day. However, there are currently few discussions on the clinical trial of in vitro diagnostic reagents from the perspective of researchers. Therefore, this article summarizes the characteristics of clinical trials of in vitro diagnostic reagents, analyzes the problems and difficulties in conducting clinical trials of in vitro diagnostic reagents in current medical laboratories, and introduces the laboratory's experience in management; to provide reference for medical testing laboratories that have not yet conducted or have already conducted clinical trials of in vitro diagnostic reagents, in order to improve the quality and efficiency of clinical trials.

Порядок и особенности проведения дезинфектологической экспертизы

The article deals with the legislative basis and peculiarities of disinfectological examination and state registration of disinfectants (disinfectants, disinfection and deratization agents), and also considers the difficulties arising in the course of these procedures. Keywords: disinfection expertise, state registration of disinfectants, state registration of products, declaration of conformity, certificate of state registration.

Development of a new test design to investigate the degradation of pesticides in soil under sunlight conditions

Pesticides applied to soil surface are subject to photodegradation if the parent molecule is sensitive to UV-light absorption. Photodegradation studies are therefore mandatory for the registration of plant protection products to provide data on the degradation rate and on the nature of photoproducts formed. In general, sunlight is simulated in these studies with xenon lamps, e.g., a Suntest® device. Surface application on very thin soil layers followed by direct irradiation is common practice, but the control of the boundary conditions, i.e. soil temperature and moisture, to maintain the structure and viability of the soil is challenging. A homogeneous and stable soil microclimate is crucial to compare the degradation data of the test item from the irradiated soil samples to the dark controls as well as to the results from the aerobic soil metabolism study. After trying different scale-up test systems with the UV-sensitive herbicide imazamox as comparative test item, a new soil photolysis test system was developed which is manageable in the laboratory and enables a more favorable management of the boundary conditions, especially with regard to the soil moisture and temperature. For this, the solar simulator SolarConstant® 1200, equipped with metal halide lamps Radium HRI-TS 1000W/D/S/PRO, was installed by Atlas Ametek (Germany) in a temperature controllable walk-in incubation chamber with aluminum racks and reflectors to minimize diffuse light and to maintain a homogenous temperature of 22(± 1)°C within the irradiated soil. Borosilicate glass vessels with an inner diameter of 10 cm and a maximum height of 9 cm, covered by quartz glass, were used for the incubation of the applied soil under light. Contrary to the imazamox degradation half-lives obtained with the Suntest® test system, where an unusual slower degradation was observed under light compared to the dark controls, the results from the new SolarConstant® study design showed the expected faster degradation under light. Hence, it can be concluded that the experimental boundary conditions of the new test system are more suitable to maintain the viablity of the irradiated soil. Since no adjustments of the soil water content were needed, compared to daily water adjustments for thin soil layers incubated under a Suntest®, drying–wetting cycles are eliminated and microbial-induced soil processes are maintained.

Pharmacokinetic Bioequivalence between Generic and Originator Orally Inhaled Drug Products: Validity of Administration of Doses above the Approved Single Maximum Dose.

Pharmacokinetic bioequivalence of orally inhaled drug products is a critical component of the US FDA's "weight of evidence" approach, and it can serve as the sole indicator of safety and effectiveness of follow-on inhalation products approved in Europe and some other geographic areas. The approved labels of the orally inhaled drug products recommend the maximum number of actuations that can be administered in a single dose on one occasion. This single maximum dose may consist of one or more inhalations depending upon the product. Bioequivalence studies for the inhalation drug product registrations in the US and EU have employed single and multiple actuation doses, in some cases over and above the approved single maximum labeled doses, thus, inconsistent with the approved labeling of the reference products. Pharmacokinetics of inhaled drug products after single and multiple doses may be different, with implications for bioequivalence determined at single and multiple doses. Scientific literature indicates that the relative bioavailability of the Test and Reference products may differ between administrations of doses in one and multiple inhalations. Multiple doses not only alter the pharmacokinetics but also may reduce the sensitivity of the bioassay to actual differences between the Test and Reference product performances. Ability of the pharmacokinetic bioassay to accurately determine the extent of difference between two products may also be substantially reduced at high doses. Therefore, in our opinion, pharmacokinetic bioequivalence to support regulatory approvals of inhalation products at doses above the recommended single maximum dose should be avoided. Furthermore, the bioequivalence of products (if any) established at doses exceeding the approved single maximum doses should be revisited to determine if the products maintain bioequivalence when evaluated at the clinically relevant single maximum doses.

Feasibility of disease terminology systems for mapping orphan conditions and therapeutic indications of designated orphan medicines in the European Union

BackgroundIn the European Union, rare diseases are defined as diseases that affect maximum 5 in 10,000 citizens. These diseases are typically associated with a high unmet medical need. To stimulate development and authorisation of medicines for rare diseases (‘orphan conditions’), the European Commission (EC) can grant orphan designations. In order to enable systematic evaluation and communication of the diseases for which designated orphan medicines have (not) been developed and authorised, we aimed to investigate the feasibility of important disease terminology systems for mapping orphan conditions and therapeutic indications. MethodsWe selected all designated orphan medicines that were authorised by the EC during 2022–2023 from the EC's Union Register of medicinal products. For these medicines, we extracted orphan conditions and associated therapeutic indications at initial marketing authorisation. The orphan conditions and separate elements of therapeutic indications such as target disease or condition, severity criteria and target population were assessed for availability in six major disease terminology systems: ICD-10, ICD-11, MedDRA, MeSH, Orphanet nomenclature of rare diseases, and SNOMED CT. Descriptive statistics were used to describe the ability of each disease terminology system to map orphan conditions and elements of therapeutic indications. ResultsDuring 2022–2023, 37 designated orphan medicines were authorised that were designated for 40 orphan conditions (of which 37 unique) and granted 39 therapeutic indications (of which 37 unique). Overall, SNOMED CT covered most descriptions of orphan conditions (33/37, 89 %) and target diseases or conditions within therapeutic indications (28/37, 76 %). However, when allowing descriptions to be partly included and/or complemented by additional words, SNOMED CT, the Orphanet nomenclature, ICD-11 and MedDRA all had high coverage (92–97 %). Other elements than target diseases or conditions within therapeutic indications were mostly lacking. ConclusionsRegulatory data concerning orphan conditions and therapeutic indications of designated orphan medicines seem to be best covered by SNOMED CT. However, which disease terminology system best facilitates systematic evaluation and communication about development and authorisation of designated orphan medicines also depends on the specific use case. Given the frequent use of SNOMED CT in healthcare settings, it may also facilitate interoperability between regulatory and healthcare data, while for example ICD-11 may be better suited to generate statistics concerning drug development for rare diseases.

Legal Awareness of Micro and Small Enterprise Operators Regarding Halal Certification: A Maslaha Perspective

The halal certification of food products is essential for consumer protection and should be harmonized with the practices of small-scale micro-producers to ensure security and mutual benefits in accordance with Islamic teachings. However, micro-businesses have been observed to possess varied perceptions toward the certification program. Based on this understanding, the present study aims to categorize awareness of the benefits and legal aspects of digitalizing the process of obtaining the certification using a theoretical legal system approach. In order to achieve the stated objective, qualitative data was gathered from different sources such as micro-business owners, halal certifiers, and beneficiaries of halal-certified food products. The obtained results showed that micro-businesses in serang-Banten often register for halal certification due to regulatory requirements and potential sanctions, rather than a deep understanding of the benefits of halal-certified products. This finding emphasized the persistence of a lack of significant awareness among micro-businesses regarding the advantages of obtaining halal certification. Accordingly, during the course of the investigation, the dominant challenges experienced include administrative complexities in the self-declaration process and the availability of qualified halal certifiers for high-risk food ingredients. To address these issues, there is an essential necessity for the development of a streamlined certification system that supports micro-businesses, facilitates application processes, and monitors the potential misuse of fake halal logos. Lastly, following the observations made, it can be inferred that digitizing the process of halal certification for both the registration and labeling of food products would improve consumer confidence and ease supervision.

Economic perspectives in pharmaceuticals: market dynamics and pricing of medications

Background: Analysing the modern pharmaceutical market is crucial for making management decisions, forming strategies, and ensuring competitiveness in this sector. Aim: Determination of the impact of various economic factors of the pharmaceutical industry on market conditions and development of economically justified areas of cost formation in the pharmaceutical market. Materials and Methods: A systematic review of scientific publications in the search databases Scopus, Web of Science, Medline, and Google Scholar was conducted. Statistical research methods used are observation, index and regression analysis. The methods of benchmarking analysis and interpretation were applied. Results: A detailed examination of published works by scientists and doctors has highlighted critical problems in forming the cost of medicinal products in the pharmaceutical market. The use of medicines worldwide and in individual countries has been considered, and a trend of increasing revenue in the global pharmaceutical market has been identified. The main approaches to forming pricing models in the pharmaceutical industry have been summarised. The peculiarities of the formation of EU legislation on the registration, production, sale, and quality control of medicinal products have been highlighted. The characteristics of the functioning of reimbursement programmes in certain countries worldwide have been described. A benchmarking analysis of the pharmaceutical market economy in Ukraine and the European Union has been conducted. Conclusions: The main directions for improving pricing policy in the modern pharmaceutical market have been outlined. It has been established that the main directions for forming the cost of medicinal products are expenses on research and development, costs of goods sold and patent expenses, marketing and advertising, regulatory and permitting procedures, and market competition.

LPPOM MUI North Sumatra Public Relations Communication Strategy in Socializing Halal Certification to Medan City MSME

This research aims to explore the communication strategies implemented by Public Relations of LPPOM MUI North Sumatra in socializing halal certification to MSME in Medan City. This study also aims to assess the level of effectiveness of this communication strategy. In the context of processing halal certification, which has significant relevance to products circulating in the Medan City community, a strategic communication approach was taken by LPPOM MUI North Sumatra to MSME traders in this region. This research uses a qualitative approach with the Grounded Research method, which allows researchers to conduct in-depth interviews with key sources. The research sources consisted of the Head of Public Relations of LPPOM MUI North Sumatra and three MSME traders operating on Jl. Tuasan, Medan City. The research results show that North Sumatra LPPOM MUI Public Relations uses various media such as print media, online media and social media in its communication strategy. However, the level of MSME product registration to LPPOM MUI North Sumatra shows a decline every year, with no registration in the 2022-2024 period. These findings indicate that the communication strategy implemented by the Public Relations of LPPOM MUI North Sumatra has not been effective in increasing awareness about halal certification among MSME traders, especially on Jl. Tuasan, Medan Tembung District. The implication is that MSME traders do not understand the process of processing halal certification both online and offline.

Body Mist-Making Training and Socialization of Cosmetic Product Registration and Marketing Authorization to Youth Organisations in Kerinci

Indonesia is an important country that produces essential oils that are widely used in fragrance cosmetic products. The use of local essential oils for cosmetics needs to be introduced to the youth generation with the aim that they do not just become consumers. Youth organisations in Kerinci have many activities to improve their skills and abilities for a better future. Collaboration between the university and the youth organisation was achieved by providing training on doing cosmetic product training on making cosmetic products. The product uses essential oils called body mist. Nowadays, the youth still know very little about the manufacturing process of cosmetics products. To provide further benefits, this community service activity collaborated with BBPOM in Padang, West Sumatra, to explain cosmetic safety and the registration process of cosmetic products. With this series topic in this training and outreach-related cosmetics, it is hoped that it can increase business ideas for young people who are members of the Sakti Alam Kerinci Organisation.

Біологічний захист рослин в Європейському Союзі (на прикладі Німеччини)

The application of ecological plant protection products against diseases, pests, and weeds is relevant for modern science-provided crop production. Much attention is paid to this problem in the European Union, where the use of pesticides is strictly adjusted by the European Food Safety Authority. Great hopes are pinned on biological plant protection products. However, among the thousands of biological products included in the BioPesticide DataBase, only a small number are authorized for use in agriculture. The requirements for the use of biological protectants in organic farming are even more stringent, regulating not only the properties of the product but also the crops in which they can be used. The aim of the work was to present the main requirements for the safety of biopesticides in the EU countries and to give an overview of biopesticides authorized for use in traditional and organic farming using Germany as an example. Methods. Analysis of EU documents on the requirements for registration of active substances in biological products for plant protection, biopesticide databases, and the list of biopesticides approved for use in general and organic farming in Germany. Results. According to the EU requirements for biopesticide safety, registration of biological plant protection products based on bacteria, fungi, and viruses, individual microbial cellular components or metabolites, as well as insect predators, pheromones, and plant-origin substances is allowed. Among the biopesticides with bactericidal and fungicidal effects registered in Germany, the preparations based on microbial antagonizing plant pathogens are prevalent, as well as preparations elaborated on the fungus Aureobasidium pullulans, Trichoderma asperellum, Verticillium albo-atrum, Coniothyrium minitans, bacteria Pseudomonas chlororaphis, Bacillus amyloliquefaciens, and also the preventive drug Cerevisan based on the cell walls of Saccharomyces cerevisiae. The following bioformulations based on Bacillus thuringiensis, Beauveria bassiana, Cydia pomonella Granulovirus, avermectin antibiotic Abamectine A, herbal products Azadirachtin A and Piretrin, and Maltodextrin are registered as insecticides. A bioformulation based on Bacillus firmus is authorized for use as a nematocide. Conclusions. Registration of biological plant protection products in Germany is carried out in accordance with the EU requirements for the safety of biopesticides. The list includes preparations based on antagonistic microorganisms, predatory microorganisms, microbial metabolites with antibiotic activity, substances for stimulation in plants nonspecific resistance to infectious agents. The fungicidal products are the widest represented. The number of products to control bacterial and nematode infections as well as the bioinsecticides spectrum is very limited. These are the well promising areas for further research and development of biological products.

A Comparative Study on Regulatory Requirements for Pharmaceutical and Biological Product registration in ASEAN and Asia Pacific Region for Parenteral Dosage Form

Regulatory requirements for pharmaceutical and biological product registration varies significantly across different regions impacting availability of critical parenteral dosage form in that market. This thesis provides a comprehensive comparative analysis of regulatory requirements for registration of parenteral dosage form in emerging markets which include ASEAN and Asia – Pacific region. The study majorly examines key regulatory framework, submission requirement, review process and lifecycle management. Focusing on how these factors affect development and market entry of parenteral product. The research explores major difference in documentation, quality requirements and product life cycle management across these markets. Data for the study is gathered from extensive review of official regulatory documents and guidelines. Parenteral means ‘Para’ + ‘Enteral’ which means those products that surpasses the intestine and directly enters into systemic circulation. The pharmaceutical parenteral products are derived from synthetic or plant-based API’s whereas biological parenteral products are derived from organisms. This thesis covers all types of parenteral registration requirements including, branded, generic and biosimilar. It includes vaccines, pre-filled syringes, bottles, vials, bags, ampoules, etc. Aim behind considering RoW market is that they are constantly updating and emerging themselves against regulatory challenges. Some of the countries in these regions have adopted ICH guidelines and others maintain unique regional guidelines. Some countries in region like ASEAN follow ACTD. Few countries like India to reduce the task of handling hard copy have established portals while few have established soft copy submission in CD/DVD or USB form while other still need submission in hard copy.

The perspective of the logarithmic field sprayer technology.

A logarithmic sprayer was suggested about 70 years ago, but it has not yet been seriously used in research and development, and subsequent registration of plant protection products. Logarithmic sprayers have resorted to mere demonstration experiments to show end users and others how plant protection products work. Fitting dose-response curves in field experiments, however, generates much essential information, e.g., extraction of various effective field rate levels (e.g., ED20, ED50, and ED80). One of the reasons for it rarely being used in the registration of plant protection products is that the dose-response curve regression was hitherto difficult to fit; the registration requirement solely focuses on analyses of variance. Another alleged obstacle is that the logarithmic plots have systematically, not randomly distributed field rates. This paper goes through some of the problems of how to non-randomly analyze field rates by taking autocorrelation into account to make the logarithmic sprayer palatable as registration documentation by assessing efficacy, selectivity, environmental side effects, general toxicity of plant protection products, and cost-effectiveness. The development in precision agriculture, drone technology, and automation of data capture and subsequent analysis could make the logarithmic sprayer a cost-effective alternative to numerous ANOVA experiments with very few fixed field rates to aid the precision spraying of pesticides and thus reduce unnecessary environmental side effects. © 2024 Society of Chemical Industry.

Biofilms, mobile genetic elements and the persistence of pathogens on environmental surfaces in healthcare and food processing environments.

Biofilms are the natural state for bacterial and fungal species. To achieve surface hygiene in commercial facilities, the presence of biofilms must be adequately considered. However, standard disinfectant and sanitizer efficacy tests required by the US-EPA and the European Committee for Standardization (CEN) do not currently consider the role of environmental biofilms. This selective review will discuss what biofilms are and why they are important. We will also cover where they are commonly found in healthcare and food processing facilities and explore how current antimicrobial test methods required for product registration do not test for the presence of biofilms. Additionally, we will explore how a lack of efficacy against biofilms may play a role in the development of antimicrobial resistance in healthcare facilities due to the exchange of mobile genetic elements that occur readily in a biofilm matrix.

АНАЛИЗ ФАРМАЦЕВТИЧЕСКОГО РЫНКА В СЕГМЕНТЕ МЕСТНЫХ ПРОТЕОЛИТИЧЕСКИХ СРЕДСТВ

The article presents the results of the seg-ments analysis of the Russian drugs and care products containing proteolytic en-zymes for topical use market. The analysis based on the data from the State Register of Pharmaceutical Products for Medical Pur-poses (GRPP), the Unified Register of certif-icates of state registration of the EAEU and the analytical company DSM Group (for the period 2019-2023). The data contains the sales volume in physical and monetary terms by medical institutions and sales by retail pharmacy organizations. It was found that the structure supply of drugs includes nine trade names (TN). The dominant drugs group is enzymes from the pancreas of cat-tle. The segment of the perfumery and cos-metics market is represented by four TN, the leaders are the brands Fermencol® and Imoferase®.

Performance evaluation of the compact water treatment system pilot project at Timah Tasoh Water Treatment Plant, Perlis, Malaysia

Abstract Clean water is crucial to ensuring the well-being of people. The Package Timah Tasoh Water Treatment Plant (WTP) is designed to support the existing conventional plant in coping with the growing demand for clean water. The package plant used the Compact Water Treatment System, classified as a Category B in the Suruhanjaya Perkhidmatan Air Negara (SPAN) guidelines; thus, this performance monitoring research was conducted prior to product registration. The plant consists of aeration, flocculation, clarification, and filtration processes. The performance of this package plant was monitored through comparative and efficiency analysis of removal parameters and carried out over a period of six (6) months. Twelve (12) water quality parameters were selected, including turbidity, pH, total dissolved solids (TDS), colour, ammonia, residual chlorine, aluminium, iron (Fe), manganese (Mn), fluoride, standard total coliform, and E. coli with sampling water of RW, SW, FW, and TW, which was then assessed alongside the drinking water quality standards set by Ministry of Health (MOH). As a result, eight key parameters such as pH, turbidity, colour, TDS, iron, aluminium, manganese, and ammonia were meeting the MOH drinking water quality standards in over 94 % of cases. The remaining parameters are chlorine residual, fluoride, E. coli and standard total coliform were in non-compliance due to the inoperability of disinfection and fluoridisation processes. Most of the significant parameters deduced a better performance in terms of removal efficiency (> 60 %) consistently, except for TDS, throughout the monitoring activity.