Marketing authorisation application, or MAA, is an application that is made to a European regulatory authority for an approval to market a therapeutic drug in the European Union.
For protecting the public health and ensuring the availability of effective, high-quality, and safe medicines for European citizens, all medicines must be approved before they can be marketed.
After receiving a grant by the European Commission, the marketing authorisation (centralised) is acceptable in all EU Member States, including Iceland, Liechtenstein, and Norway.
The information submitted by the pharmaceutical companies in their application for marketing authorisation should comply with the EU legislation.
The medicine developers must include information such as the process of medicine manufacturing, its effects in laboratory studies, benefits as well as side effects observed in patients, among others.
A committee of experts, the CHMP, assesses the authorisation applications. Each of its members is backed by a team of assessors. The CHMP evaluates the EMA applications submitted by the manufacturer companies and advises whether a medicine should be granted marketing authorisation. During the process of evaluation, the CHMP also works with other EMA committees.
The European Medicines Agency (EMA) has the responsibility of conducting the scientific assessment of centralised MAA in EU. The procedure allows pharma companies to submit one MAA to the agency and to market the medicine.
To determine whether a product can be assessed under the centralised procedure, the applicants should always submit an eligibility request using the particular form and complemented by a justification. The steps before submitting an application are-
Submission of the application- After submission, the EMA performs a technical confirmation of the applications. The intention is to make sure all necessary regulatory elements needed for scientific assessment should be included in the application before commencement of the procedure.
Assessment of the application- The CHMP (Committee for Medicinal Products for Human Use) assesses MAA submitted via the centralised procedure. The evaluation is done with input from the PRAC (Pharmacovigilance Risk Assessment Committee) and the Committee for Advanced Therapies for advanced-therapy medicines. This process can take up to 210 active days.
The decision of the European Commission on the marketing authorisation- The European Commission is the authorising group for all the medicines which are authorised centrally. The Commission takes a legally binding decision based on the recommendation by the EMA.
The EMA has the responsibility to evaluate the scientific evaluation of applications for centralised marketing authorisations.
After receiving grant by the European Commission, the centralised marketing authorisation is valid in all EU including Iceland, Liechtenstein, and Norway. With the grant, the marketing authorisation holder can market the medicine and provide it to patients as well as healthcare professionals all over the European Economic Area (EEA).
All medicines which are for human use and derived from biotechnology or any other high-tech manufacturing methods should be evaluated by the agency through the centralised procedure.
The same is applicable for all advanced therapy medicines as well as medicinal products comprising new active substances to treat cancer, diabetes, neurodegenerative diseases, HIV/AIDS, auto-immune and other immune dysfunctions, including viral infections.
Moreover, the authorisation is also applicable for all designated orphan drugs meant to treat rare diseases.
For medicines which are not under any of the drugs mentioned above, the manufacturer can submit an application to the EMA, if the drug is a new active substance, has a significant therapeutic, technical, or scientific innovation.
Generics of centrally authorised products and applications for specific medicines for paediatric use may be permitted in this way. Therefore, the agency does not assess all medicines currently in use across Europe.
For medicines which are out of the above scope of the centralised procedure, the decentralised, mutual-recognition, or entirely national authorisation procedures should be applied, depending on the number of nations in which authorisation is required.
However, in a few some cases, when a treatment for a life-threatening disease, without any available treatment, is needed, the EMA can recommend marketing authorisation based on limited evidence on the medicine. In this case, further data is required to submit by the manufacturer at a later stage.
After a decision has been undertaken on the approval or refusal of marketing authorisation, the agency announces a complete set of documents termed as the European public assessment report (EPAR). This document comprises the public CHMP assessment report, describing the data assessed in detail and why the CHMP advised approval or rejection of authorisation.
What is Data Analytics? Data Analytics involves a set of quantitative and qualitative approaches and processes that can be used to determine useful information for business decision-making. The process involves various patterns and techniques, including: extracting a raw database, and categorising it to identify and analyse the behaviour, relation and connection of the results. The ultimate goal is to acquire valuable information in order to make decisions for businesses’ benefit and productivity. In today's competitive times, most companies chalk out their business plan with the help of data analytics. With organisations becoming customer-service oriented, data analytics has become a critical tool to reach the target audience in an effective manner while understanding their requirements. Once data is collected, it is analysed and stored according to organisations’ requirements. The data analysis process has multiple layers involved, and its diverse modules are not just used in businesses but also in science and social science fields. Rather than making decisions based on just available information, one can utilise data analytics in examining the data in standard ways and churning out the results from it. It has been observed that companies generally make decisions based on past references and future outcomes. Data analytics appears advantageous in providing useful information towards this end. Why do Businesses Need to Use Data Analytics? Many data analytics’ tools and softwares are readily available these days. These systems use resources, such as machine learning algorithms and automation. Data scientists and analysts are counted amongst the leading career options as well. These professionals use data analytics techniques while researching and presenting useful information for businesses to increase productivity and gain. The process helps companies understand their target audience and determine effective ways to cater to their needs. Data analytics can further be used to design strategies in marketing campaigns and promotions and also evaluate its results. Data analytics is primarily used in business-to-consumer (B2C) processes to boost business performance and improve the bottom line. There are data collection firms which gather consumer information and provide it to the businesses so that the companies can effectively influence the market. The collected data is not only used to understand and impact consumer behaviour but also determine market economics and its practical implementation. The data used in the process can be either be data collected in the past or newly updated data. There are various methods to manage consumer and market information. It may come directly from the customers or potential customers or can be purchased from the data collection vendors. The data primarily includes audience demographics, behavioural patterns and expense threshold. How Can Data Analytics be Effectively Used in Business Processes? Data analytics is an ever-evolving technique. Earlier, the data was collected manually, but with the rise of internet and technology, data is now collected online with the help of search engines and social media platforms. Subsequently, the information is analysed through available software. Here is a list of some key steps businesses can follow to leverage the benefits of data analytics: Set up crucial metrics: This step reduces the guesswork and provide data-based insights to the businesses. Before embarking on the data analytics process, it is vital to determine the goal for your business. Analysing customer data helps in understanding conversion rate, consumer spending ability, demographics etc. The results of the analysis can support the businesses while making decisions in launching an advertising or marketing campaign. Similarly, the unwanted data can be erased from the database so that the brands can focus on their right target audience. The relevant metrics will change the course of the company and push it in the right direction. Moreover, once your key metrics are set, even when the market conditions change in the future, you can adjust the metrics according to the requirement and achieve the results. Set a clear module: It is important to examine the data correctly by avoiding common mistakes. An ambiguous path can produce confusing insights while wasting time and energy of businesses. Therefore, it is recommended to draw a clear goal in order to achieve actionable insights. The data, when collected from different sources, need to be merged accurately in the analytics model. Businesses can modulate their data analytics systems either manually or through automation. There are various data modelling practices available in the market. The best use of these techniques can simplify the process of modelling complex data. Data visualisation: Once the relevant data is collected, and the modules are set to analysis, visualisation of that data will assist in understanding the information correctly. When the businesses have an acute knowledge of what their target audience wants, they can then focus on strategising advertisement and content, which matches the consumers' interest. It is the critical step in the data analytics process to distinguish insights from information. Not everyone is comfortable dealing with numbers. Hence, ensuring that key stakeholders understand essential points and information can be displayed in a visually appealing format seem crucial to capitalise on data effectively. Right tools to implement insights:Having access to data and insights can get overwhelming. However, the information is worthless if the businesses are unable to implement it successfully. While it is important to collect the data and set critical metrics and modules to analyse it, it is also imperative to translate the data into practical actions. The eventual goal is to improve sales or grow profits. It is ultimately in the marketers' hands to transform the gained insights into a successful implementation. The consumers' insights should be incorporated while establishing a marketing plan and at all decision-making steps.
What is data warehousing? Data warehousing is defined as the method of gathering & handling data from different sources to get meaningful output and insights. Data warehousing is central to the BI system and is built for data analysis and reporting. Source: © nfo40555 | Megapixl.com In simple terms, a data warehouse is a large collection of data utilized by businesses to make investment decisions. What are the characteristics of data warehousing? Data warehouse has supported businesses in making informed decisions efficiently. Some of its key features are highlighted below: The data in a data warehouse is structured for easy access, and there is high-speed query performance. The end users generally look for high speed and faster response time – two features present in data warehousing. Large amount of historical data is used. Data warehouse provides a large amount of data for a particular query. The data load comprises various sources & transformations. What are the benefits of data warehousing? The Companies which used data warehousing for analytics and business intelligence found several advantages. Below are some of them: Better Data: When data sources are linked to a data warehouse, the Company can collect consistent and relevant data from the source. Also, the user would not have to worry about the consistency and accessibility of the data. Thus, it ensures data quality and integrity for sound decision making. Faster decisions: Through data warehousing, it is possible to make quicker decisions as the data available is in a consistent format. It offers analytical power and a comprehensive dataset to base decisions on tough truths. Thus, the people involved in decision making do not have to rely on hunches, incomplete data, and poor quality data. It also reduces the risk of delivering slow and inaccurate data. How does a data warehouse work? A data warehouse is like a central repository where the data comes from various sources. The data streams into the data warehouse from the transactional system and other relational databases. These data could either be structured, semi-structured or unstructured. These data get processed, altered, and consumed in a way that the end-user can gain access to the processed data in the data warehouse via business intelligence (BI) devices, SQL clients and spreadsheets. A data warehouse merges the data that comes from various sources into a complete database. The biggest advantage of this merged data is that the Company can analyze the data more holistically. It also makes the process of data mining smooth. Copyright © 2021 Kalkine Media Pty Ltd. Component of a data warehouse A data warehouse can be divided into four components. These are: Load Manager Load Manager, also known as the front component, does operations related to the mining and loading the data into a data warehouse. Load manager transforms the data for entering into Data warehouse. Warehouse Manager The warehouse manager manages the data within the data warehouse. It analyses data to confirm that the data in the data warehouse is steady. It also conducts operations such as the creation of indexes and views, generation of denormalization and aggregations, modifying and integrating the source data. Query Manager Query Manager is a backend component that does operations concerning the supervision of user queries. End-User access tools End-User access tools comprise data reporting, query tools, application development tools, EIS tools, data mining tools, and OLAP tools. Roles of Data Warehouse Tools and Utilities The tools and utilities in a data warehouse are used for: Data extraction: The data extraction process involves gathering data from heterogeneous sources. Data cleaning: Data cleaning consists of searching for any error in the data. Data transformation: Data transformation process involves changing the data into a data warehouse setup. Data loading: This process involves data sorting, recapping, consolidating, verifying integrity. Refreshing: This process requires revising data sources to the warehouse. Application of data warehouse Data warehouse plays a considerable role across multiple sectors. Some of the sectors it caters to are highlighted below. Aviation sector In the aviation sector, a data warehouse’s role can be seen in crew assignment, route profitability analysis, any promotional activity. Banking Industry In the banking sector, the focus is on risk management, policy reversal, customer data analysis, market trends, government rules and regulations and making financial decision. Through a data warehouse, banks can manage the resources available on the deck effectively. Banks also take the help of a data warehouse to do market research, analyze the products they offer, develop marketing programs. Retail industry Retailers act as an intermediary between the producers and the customers. Hence, these retailers use a data warehouse to maintain the records of both producers as well as the customer to maintain their existence in the market. Data warehouses help track inventory, advertisement promotions, tracking customer buying trends and many more. Healthcare industry In the healthcare industry, a data warehouse is used to predict the outcome of any test and taking relevant action accordingly. Data warehouses help them to generate patient treatment report, offer medical services, track the medicine inventory. Many patients visiting hospital have health insurance. Through a data warehouse, hospitals maintain the list of insurance providers. Investment and insurance sector In the insurance and investment sector, the role of data warehouse becomes important in tracking the data pattern, customer trend and market movement. Services sector In the services sector, a data warehouse is used for maintaining financial records, studying the revenue pattern, customer profiling, resource management and human resource management. Telecom The telecom sector uses a data warehouse in the promotion of its offerings, making sales decision, distribution decision, features to include in case they decide to launch a new product based on the customer requirement. Hospitality The hospitality sector involves hotel and restaurant services, car rental services etc. In this sector, the companies use a data warehouse to study the customer feedback on the various services offered and accordingly design and evaluate their advertising and promotion campaigns.
What are GAFAM Stocks? GAFAM Stocks are perhaps the most famous and sought-after stocks of the last decade. The dominance of these companies during the 2010s in the stock market will be remembered in the books and adages. It is the creation of market participants that develop acronyms like GAFAM, which include five large American companies having dominance across most jurisdictions. GAFAM stands for Google, Apple, Facebook, Amazon, and Microsoft. Over time these companies have gained dominance in their primary business. In addition, GAFAM stocks have been aggressive in expansion and entering new verticals. Although there have been considerable acquisitions along the way, the investments in research & development and innovation have been at the forefront of the capital expenditure plans. Google Officially known as Alphabet Inc., ‘Google is not a conventional company’ is a statement made by its founders in their early letters. It has not been a conventional company, indeed. Google has developed significant networking within its products. As a dominant search engine of the world, Alphabet reaps large revenue through advertisements through its flagship search engine and other products. Over the years, the company has been able to expand in other verticals such as mobile phone operating system – Android, web browser through Google Chrome. Alphabet has two operating segments. Under Google, the company houses Search engine, YouTube, Search, Google Play, Google Maps, Android, Chrome, hardware, Google Cloud. In other bets, the company includes businesses that are not material individually. These businesses include Calico, Verily, Waymo, CapitalG, GV, X and more. Almost all revenue of Alphabet is derived by Google segment. In 2019, Alphabet recorded revenue of $162 billion, and around $161 billion was derived from Google segment. Operating income of the company was $34.2 billion, while net income of the company was $34.3 billion. Read: Unboxing Revenue Growth Streak of Google and Microsoft Apple Established in 1977, Apple Inc. is a consumer electronic company engaged in manufacturing of various consumer products. Apple mobile phones are renowned across the world, and it also makes personal computers, wearables, tablets, and accessories. iPhone is the flagship mobile operates on an in-house developed iOS operating system. Mac is a brand for its personal computers that are also used extensively across the professional domain. iPad is a line of tablets, which run on iPadOS. Apple also sells other wearables and accessories that include Apple Watch, Apple TV, Beats products, iPod Touch, Airpods. The core strength of the company has been its capability to innovate and launch products continuously. iCloud is its cloud service, and data of its products can be stored in the cloud. As a consumer business, it markets are focused small individual customers that do not constitute a material portion of revenue individually. In 2019, Apple recorded revenue of $260.2 billion. Its operating income for the period was $64 billion, while net income was $55.25 billion. Facebook Facebook Inc. was established as a social networking website and has grown tremendously due to its strong networking effects. It enables people to connect with each other or in groups. Facebook is used in mobile phones, personal computers, handsets etc. It has been a great place to share opinion, ideas, videos and photos. With its large user base, Facebook and its products are used for advertisements. The traditional modes of advertisements have lost significant market share to companies like Facebook. Instagram is also a part of Facebook. It is used by people across the world to share photos and videos. It also offers a similar type of services like Facebook and has emerged as a networking platform for digital creators and influencers. WhatsApp is a messaging mobile phone application. It allows people to connect privately and is extensively used by people. Messenger is another application by Facebook that enables people to connect with family, friends, groups and businesses. Oculus is the hardware business of Facebook that helps to connect people through its virtual reality products. A major portion of revenue is generated by marketing and advertisement through its products that are used by large scale potential consumers. Watch: Facebook launching 'Shops' on its social Media Platform | Market Update Amazon Amazon.com, Inc. was established as e-commerce in 1994. The company serves consumers, sellers, developers, enterprises, and content creators. Amazon also provides advertising services to publishers, sellers, vendors, publishers, and authors. It serves consumers through its online and physical stores. Amazon offers a range of categories and is has a strong online retail presence. It has been engaged in manufacturing consumer electronics such as Kindle, Fire TV, Fire Echo, Alexa, Ring etc. Amazon Prime is a membership of the company that provides shopping benefits, streaming of entertainment content, including movies, original content. It intends to provide customers with low prices and home delivery of goods. It also enables sellers to access Amazon marketplace, which includes stores and online website. Amazon earns through a percentage of sales, fixed fee, combinations etc. Amazon Web Services offers cloud service to a range of public and private enterprises to store data. Kindle allows content creators to publish and sell content/books on Kindle and earn a royalty on sales. In 2019, the company recorded net sales of $280.5 billion. Operating income for the year was $14.54 billion, and net income was $11.59 billion. Microsoft Microsoft Corporation is a technology company that develops software, services, devices and solutions. Its products are extensively used by businesses and individual customers to operate personal computers. Microsoft’s platforms allow improving small-businesses productivity, educational outcomes, driving competitiveness of large businesses. As a platform and tools provider, the company empowers enterprise and organisations of all sizes. Now it is emphasising on innovation for the next phase of computing stage. Other than its legacy operating system, Microsoft provides cloud-based solutions, services, software, platforms, content, server applications, desktop management tools, software development tools etc. It also designs and manufactures and sell devices, including gaming consoles, PCs, tablets, entertainment consoles, and related accessories. In 2020, the company recorded revenue of $143 billion. Operating income for the year was $53 billion, and net income was $44.3 billion.
Capital Expenditure (CapEx) What is Capital Expenditure? Popularly called as CapEx, it means the expenditure incurred by an entity in maintaining, upgrading or purchasing non-current assets. Capital Expenditure is the amount spent by an entity on fixed assets with the usage of over one year and intangible assets. Private Capital Expenditure is often used as a proxy for non-public investments. A higher level of CapEx may indicate that investment is higher, and the reverse is true. Therefore, CapEx by corporates serves as a proxy for private investments to some extent. In accounting terms, it hits cash flows from investing activities along with movement in value or scale of assets. In the next year, the company will charge Depreciation and Amortisation on the asset, which will hit Income Statement. Investment into intangible assets is also considered capital expenditure as patents, rights, trademarks, Knowhow, technology would provide benefits to the business over the years. Fixed assets investments of businesses include the purchase of machinery, upgrade to machinery, incorporating a new plant. Moreover, CapEx being an expenditure is added to assets of business since it would deliver benefits over the future. Revenue Expenditure vs CapEx Revenue Expenditure of a company includes its operational expenses where the benefits to business from such expenditure would be short-term. It would include marketing expenses, distribution expense, employee costs etc. These expenditures are not capitalized and thus are booked in the profit and loss account. Whereas CapEx by a company would deliver the benefits to the business for more than one year and allow the business to grow sustainably over the future. CapEx is often planned and budgeted for years and includes a higher level of evaluation by the management. The management often segregate the capex as growth or maintenance capex. More on this: Growth Capex Vs Maintenance Capex – Aping the Convention or an evolving distinction? Types of Capital Expenditures Asset purchases: It means when an enterprise buys asset to benefit the business over the long run. A purchase of a new building would enable the business to increase its scale of products, and the new machinery installed in the building would manufacture products or aid in the manufacturing of products until the useful life of the asset. Do Read: Restaurant Brands New Zealand to Purchase KFC Stores Asset improvements: It may include any upgradation to the existing asset base of the company, including a new software or technology, the addition of new part to improve output from existing assets, or maintenance of the assets held by the business. Intangible assets: Expense incurred by a business in developing or acquiring intangible assets, like patents or trademarks, are also capital expenditure since the expected value from the assets would be realised over the long-term. DO Read: TNG Limited To Trademark Its Titanium Dioxide Pigment As TNG360 Why is CapEx important in investing? Investment is necessary to grow a business, and capital expenditures often set the path for growth in businesses. Management seeks to deliver the best out of its resources, which may require further enhancements to fulfil the vision of the business. CapEx seeks to derive further value for an enterprise through enhancements of existing assets, acquisition of new assets, adoption of new technology etc. It is an important decision that management of business seeks to take continuously and efficiently. CapEx by companies depends on various factors, including business model, products, industry, size, scale. For instance, a large scale mining company like BHP Group Limited (ASX:BHP) requires a much higher level of CapEx compared to an online retailer like Kogan.com Limited (ASX:KGN). But the expectations remain similar: to have a long-term sustainable revenue stream, enhancements to business models, or improvement in the profitability and sustainability of the business. Investors monitor capital decisions of firms very closely to ascertain short-term as well as long-term implications. Since Capital Expenditure often includes large sums of money, it becomes imperative for investors to evaluate CapEx decisions of firms, sources of funds employed in CapEx, or expected liquidity of the business over the near-term. Moreover, investors seek to test the capital budgeting by the management. However, there can be failures as well when the management expectations are not delivered by the past CapEx decisions. When things don’t turn as expected, it is likely that blame would be on management, but they would be appreciated when things turn out better than expected. It is the reason why investors devote a decent time to study the management style of the Board. Management takes the ultimate call for Capital Expenditure plans of a business, and they must evaluate the investment through a sound cost-benefit approach. The source of funds for the Capital Expenditure should also complement the long-term sustainability of the business. Companies fund their Capital Expenditure plans through debt or equity, and management must consider the appropriate source of funds to deliver expected benefits. Click here, to know about Afterpay Limited (ASX:APT) capital raising plans. Capital intensity and rise of Capital light business models Capital intensity of a business depends on the type of business. Large businesses that require heavy assets or regular enhancements would have large Capital Expenditure plans and need for capital, but a software company with a similar scale of revenues may not need huge Capital Expenditure. Capital intensive businesses come with long-term, a higher level of CapEx, and it is crucial for such business to manage CapEx plans. Companies engaged in Mining, construction business, equipment manufacturing, automobiles, energy, transports are considered as capital intensive business. Capital light business models have grown popular over time due to high margins and profitability. Such business models are expected to deliver relatively higher levels of free cash flows to the company over time. In asset-light businesses, the intensity of operational expenses or Revenue Expenditure is higher compared to CapEx. E-commerce companies like Amazon.com, Kogan.com Limited (ASX:KGN), Temple & Webster Group (ASX:TPW) are Capital light businesses. 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