Comparison of Biomedical Product Development in the United States and Singapore
Introduction
Over the past years, biomedical research has proved impactful in improving and advancing healthcare systems across the globe. By integrating knowledge from the chemical, mathematical, and computational sciences fields, a foundation of unleveled knowledge on concepts of organs and tissue molecular compositions has proved reliable in healthcare improvement. Chen et al. (2018) indicate that biomedical research has developed innovative processes, biologies, devices, and interventions for disease prevention, diagnosis, and treatment hence contributing to the increased health improvement. However, the safety of biomedical products is a vital element that attracts regulatory systems for humanity’s welfare. Ideally, these products have a ranged rate of risk levels that requires regulation to ensure that despite their effectiveness, their flaws do not outrun their efficiency to the humans. In this light, it is worth noting that biomedical product development management is comprehensive and varies widely across the globe. More so, control of these processes evolves continuously due to the need for better consistent approaches to regulatory documentation. The World Health Organization offers an organizational program model that assists states in establishing legislative criteria on BioMed products (Chen et al., 2018). The main aim was to ensure that nations produce regulations that are internationally compatible to enable manufacturers to sell their products in the world market. Among the biomedical products regulated are the medical devices that have attracted a series of applications within and outside the healthcare spectrum (US Food & Drug Administration, 2020). Research indicates that the US is the leading in biomedical innovations by creating a remarkably refined framework that develops biomedical inventions and availing them to the marketplace (DeVol, Bedroussian& Yeo, (2011). However, this leadership is slowly being eroded by Singapore and other emerging biotech states like China and Japan through their careful and impressive strides. Conventionally, legislative approaches to control biomedical developments in these states are taking practical steps to ensure public safety in the broader continuum. This involves an evaluation of product design, manufacturing processes, pre, and post-marketing strategies. In this light, this report will focus on the regulatory approach in the US and Singapore, with a closer glimpse of how harmonization is done on the changing circumstances in the biomedical field.
Scope of Biomedical Regulation Framework in US and Singapore
The Food and Drug Administration (FDA) is the federal regulatory body that oversees drug production and juggles prospects concerning human consumption in the US. In liaison with the National Health Institute, regulation processes embedded in forward-thinking policies have ensured proper control of drug manufacturing and selling in the US market and state lines. The FDA is attributed to doing reviews efficiently regarding drug regulation to ensure accomplishments on its strategic goals regarding patient safety. In this light, DeVol, Bedroussian & Yeo (2011) explain that the FDA achieves monitoring and regulation through the Investigational New Drug (IND) policy that offers manufacturers legal requirements to engage in biomedical production. For instance, after product identification, the FDA requires the manufacturer or the drug’s sponsor to screen the new molecule on pharmacological activities and acute toxicity in animals before assessing its diagnostic efficiency in humans (US Food & Drug Administration, 2020). This testing is based and founded on the Federal Food, Drug, and Cosmetic Act stipulations that state-specific requirements for drug development to be accomplished. Generally, Daniel & Romine (2012) highlight that the FDA’s mission is to lay across the US Congress stipulations and the agency’s mission to protect public health and safety. The Federal Food, Drug, and Cosmetic Act play an impactful role in assuring consumers that foods are pure and safe to consume, drugs and devices are safe and effective, and those cosmetics are made from appropriate ingredients (Lybecker, 2016). Through the Code of Federal Regulations (CFR) Section 21, the Federal Law has managed to convey an interpretive dimension of its acts regarding food and drugs.
On the other hand, in Singapore, the Health Sciences Authority (HSA) is the regulatory framework that oversees the regulation of drugs, innovative therapeutics, and medical devices. The primary role is implicated by the need to ensure the safety of health products, ascertain they meet the appropriate quality and standards to ensure the development of national drug policies. According to Yuling (2014), the HSA is responsible for product registration, auditing manufacturing processes, assessing clinical drug trials, and evaluating the distribution strategies. More importantly, the HSA conducts surveillance on medical products and enforces actions regarding illegal activities as a means of response towards adverse drug cases (Pacific Bridge Medical, 2018). The HSA accomplishes these roles through the Health Products Act of 2007 that provides a regulatory framework on manufacturing, importing, procurement, storage, advertising, and packaging of health products in the country. This is inclusive of medical devices and therapeutic/pharmaceutical products. For instance, the Singapore HSA regulates medical devices by categorizing them into classes A, B, C, or D, which helps determine the registration protocols (Pacific Bridge Medical, 2018). More so, the Health Sciences Authority has a set of databases such as the Singapore Medical Device Register (SMDR) that provides an updated list of the applicable medical devices on patients. On the other hand, pharmaceutical regulations are controlled by New Drug Application (NDA) and the Generic Drug Application (GDA) categories that help differentiate between biological and chemical products, respectively. Also, Singapore regulates foreign manufacturers through the Accounting and Corporate Regulatory Authority (ACRA) as a registering body for such firms to operate within the state.
Comparison
Regulation on Large Molecule Production
In the past years, drug production has majorly been centered on small molecule drugs made up of small and sizable atoms. For instance, drugs like Aspirin are the majority of building brand names across the biopharmaceutical firms across the globe (Price, Nicholson & Rai, 2015). However, innovations and inventions based on small molecule drugs have proved challenging to generic drug manufacturers and scientists. In this light, the focus has changed for biomedical engineers and producers to extensive drugs primarily made from living cells. According to Price, Nicholson & Rai (2015), large molecule drugs or rather known as biologics, are far-reaching and advantageous compared to small molecules based on their improved capability for patient treatment and the high marginal acceleration of company profits. Despite this appropriateness and convenient capacity, biologics’ manufacture tends to be more complex, thus raising challenges towards innovation and competition for the biopharmaceuticals (Lybecker, 2016). In this light, governments are intensively integrating resources, both technological and intelligence-wise, to ensure that the product development is secure, sustainable, and for the public’s more considerable benefit.
For instance, in Singapore, biologics production application for both domestic and foreign manufacturers is closely monitored by the Health Sciences Authority (SaiBhavani, Venkatesh & Kumar, 2020). The complexity of the registration and application processes deems it quantified for the public’s safety and secure quality of products. According to SaiBhavani et al. (2020), the significant attractive investments and high rates of sales revenues represent improved development in the overall biopharmaceutical industry. The Federal Food and Drug Administration, on the other hand, controls biologics production through its distribution centers on through where applications and licenses for production are made (US Food & Drug Administration, 2020). For instance, Dailey (2018) identifies the Centers for Biologics and Evaluation Research, and the Center for Drug Evaluation and Research through their directors are primary constructs through which the FDA controls biologics development and production. However, some implications present an autonomous situation characterized by negativities in intellectual property capacities (Dailey, 2018). In this light, both the US and Singaporean governments have instituted staunch safety acts, especially on intellectual property rights, to ensure manufacturers and developers are not overthrown. Singapore specifically restituted the pharmaceutical regulations through the amendment of the Patent Bill of 2004 (Pacific Bridge Medical, 2018). The clause provided for flexibility of patent terms, where the patent term, for instance, begins even when the product is not approved yet. Unfortunately, this stipulation, in most cases, is detrimental to manufacturers since delays may be experienced in wait for market approval, hence ending up losing a lot of time (Pacific Bridge Medical, 2018). The bill also balances patent owners and pharmaceutical users by altering the parallelism in the importation of rules on pharmaceutical products. Simultaneously, the country offers an improved system of its patent approval processes that will cater to the firm’s needs compared to the previous methods (Yuling, 2014). More so, the need for accessibility of production procedures has prompted liaison with other regulatory bodies such as the European Medicines Agency (EMA) and merging efforts with the US Food and Drug Administration. This was aimed to regulate biologics production as well as monitoring patent regulations to safeguard the pharmaceutical industries.
Regulation on Drug Development Research
Drug development research is dependent on the laboratory processes where scientists identify possible gaps and suitable interventions to study on. Researchers identify possible insights on disease processes during this stage that may allow them to reverse their effects (US Food & Drug Administration, 2020). They may examine previous impacts that have not met anticipated outcomes or develop new technologies that may provide improved insights to gauge medical products more reliably. In either way, multiple compounds form candidature for drug development that would better medical treatments. Development involves various examinations based on the absorption, distribution, and the overall metabolism of the drugs (Sushma, Arvapalli, Sharma & Kiranmai, 2019). Also, evaluation of administration methods, the impacts of the drugs on different people, side effects, and the interaction with other medications are other essential elements of this phase. According to Sushma et al. (2019), the evaluation of the drugs’ effectiveness compared to others and their potential benefits as mechanisms of action is also a vital step during drug development. These processes align with the FDA stipulations based on discovery and development (Sushma et al., 2019). Simultaneously, the FDA requires researchers to apply the good laboratory practice (GLP) guidelines during preclinical studies to provide insights on dosing and toxicity levels of the drugs under scrutiny (US Food & Drug Administration, 2020). The GLP offers basic requirements on personnel, study conduct, equipment, and quality assurance system that acts as oversight to ensure the safety of FDA regulated products.
Additionally, during clinical trials, the FDA extends its regulations to ensure subject safety since they involve tests carried out on people (US Food & Drug Administration, 2020). This is where the FDA applies its process on the Investigation New Drug process (IND) that provides for application before clinical research. In this stance, the FDA requires researchers to offer information based on animal data and toxicity, study protocols, information on prior research, and investigators’ data. After a successful examination of the drug’s safety to subjects, the FDA reviews and progresses its safety monitoring after the sale. Similarly, Singapore controls her pharmaceutical developments and research through the Center for Drug Administration, a branch of the Health Sciences Authority (HSA). According to SaiBhavani et al. (2020), the CDA controls drug development through its division acts such as Medicine Act, Poisons Act, Sale of Drugs Act, and the Misuse of Drug Regulations. These bodies ensure that researchers observe good Manufacturing Practice (GMP) guidelines during drugs’ developmental phases (SaiBhavani et al., 2020). More so, the CDA is responsible for ensuring Good Distribution Practice alongside post-sake surveillance that ensures the safety of products availed to the public (SaiBhavani et al., 2020). The availability of these regulatory bodies in both the US and Singapore has ensured maximum public safety by producing quality products that meet healthcare needs.
Public Influence on Drug Regulation
Ideally, all efforts on drug innovation and development are tailored towards the public’s wellbeing in terms of safety and disease reduction through diagnosis and treatment. Dailey (2018) observes that the public plays an impetus role as a major stakeholder on the effects of each development made. This is because, one, they are used as test subjects to evaluate the efficiency of the discovered drugs, and they are the same beings in which the same drugs are administered after proving their efficiency (Dailey, 2018). In this light, research indicates that the public defines the effectiveness of drug regulation strategies through their perceptions of drug interventions, the impact of these drugs on them, and the reliability and convenience (Sushma et al., 2019). This means that policy development on drug regulation should be centered on the public’s interests to safeguard their health in the broader continuum.
Conventionally, this is the case in both the US and Singapore, as the regulatory acts are formed through constant discussions on the wellbeing of the public (Sushma et al., 2019). For example, in the US, regulations are discussed in the US Congress as a representation of the people that advocate for public interests throughout the amendment processes. At the same time, revolutionary changes in the regulatory approaches due to drug development’s evolution are a matter of public concern (Dailey, 2018). Dailey (2018) indicates that regulatory agencies that act as oversight to drug development, drug evaluation boards, quality control labs, and drug information centers are significant figures within which public interests are addressed and considered. The expansion of the scope of laws regulating drugs through the strengthening of regulations has been influenced majorly by the growing catastrophe of public demand for more restrictive rules (Dailey, 2018). In other instances, Price, Nicholson & Rai (2015) highlight that the public may feel that the rules are too restrictive while approving for drugs in the market. This attracts government response like streamlining laws and regulations on cancer and AIDS drugs (Price, Nicholson & Rai, 2015). Generally, the public checks the excesses of drug regulatory agencies, mainly where measures made to approve new drugs result in the marketing of more toxic drugs. In this light, it is worth noting that the drug’s regulations will continuously remain lax since public perception changes over time and the growing need to avoid drug catastrophes.
The Relevance of Biomedical Regulation
As the healthcare field advances in terms of medical needs and the evolution of diseases, so does the biomedical research spectrum. Chen et al. (2018) indicate that it collectively attracts intellectual knowledge, skills, and competencies across various fields to supplement and replace the existing treatment methods to secure a better health population. However, the efficacy and transparency of the drug development and production processes is a key element that every government seeks (Daniel & Romine, 2012). In this stance, the regulation of drug production properties is an empirical aspect that governments and concerned authorities should prioritize. This is because of the existence of atrocities in the production firms, where shifts happen and drug efficiencies are compromised. Also, (Daniel & Romine, 2012) in clinical trials, human subjects may be exposed to unaccustomed trials that endanger their health. Therefore, staunch regulation strategies have been implemented that are flexible and convenient to change with the dynamism in biomedical technology and drug development processes. According to Sushma et al. (2019), the efficacy of drug regulation cannot be overlooked as it has been attributed to increased human safety and detection of contraband productions. As the world advances, the greed for money yields illegal acts such as the transformation of development plants to illegal drug centers. More so, Chen et al. (2018) express that the problem of market exploitation through hoarding and overpricing of drugs is on the rise. This has ultimately attracted strict regulation rules that both the Food and Drug Administration and the Health Sciences Authority have immensely overseen their adherence. Also, Chen et al. (2018) highlight the existence of fake products is also another reason for regulation. Corruption in the biomedical and drug market has been an issue that both the US and Singaporean governments fight countless times (Sushma et al., 2019). In this light, research indicates that the transformation of the regulatory elements of the drug system over the last years has shifted from regulating interstate transport and misbranding of products to become pillared in the goals of creating reliable standards, processes (DeVol, Bedroussian & Yeo, 2011). These aspects have been consistent in enhancing the degree of safety as well as the efficacy of medical agents.
Through Research and Development (R&D), regulatory reviews, manufacture, distribution, and marketing of products, and application of medications, the government has adequately controlled the biomedical sector (US Food & Drug Administration, 2020). These are essential stages in the biomedical processes through which regulatory approval has played an impetus role in enforcing standards that govern each. Compliance with the set standards is the responsibility of manufactures while safe and effective application of medications is attributed to healthcare providers responsible for prescribing medicines to patients (US Food & Drug Administration, 2020). Generally, regulatory authorities build the safety of products by ensuring sound scientific research and reliable clinical tests that are based on ethical stipulations about test subjects. Further, Sushma et al. (2019) spotlight that regulation reflects on rigorous reviews, appropriate labeling of products that indicate side effects, and other relevant information about the product. At the same time, drug regulation oversees proper manufacturing processes, appropriate distribution approaches that employ ethical marketing practices, and competent prescription, dispensing, and administration of drugs (SaiBhavani et al., 2020). The FDA and HSA are mandated to ensure that each of these standards is met to safeguard public health safety. Ideally, regulation has yielded increased public safety and quality products that are globally recognized as efficient and convenient for human health.
Conclusion
Biomedical and drug development is among the US and Singapore government’s critical sectors as it forms an integral construct of the healthcare spectrum. In this stance, both countries have adopted initiatives that safeguard the operations and effectiveness of this sector. Innovations in this sector, for instance, require constant reviews, evaluation, and monitoring to assess their efficacy and efficiency on the human fraction. The US Food & Drug Administration and the Health Sciences Authority of Singapore are the elementary bodies in charge of biomedical regulation. The two bodies are mandated to safeguard public health as the priority of any development alongside ensuring quality and effective standards are reached. The two bodies are responsible for registration, monitoring, and reviewing production processes. Large molecule production and drug research development are crucial phases in the biomedical research where each authority exerts its mandated power. In Singapore, HSA regulates biologics production and drug development research through the Centers for Drug Administration that oversees application requirements are met before registration. The US FDA conducts this responsibility through its distribution centers such as the Centers for Biologics and Evaluation Research and the Center for Drug Evaluation and Research. More so, acts governing production differences between the two states; however, the relevance and goals of the two bodies are tailored towards securing the best interests in terms of public health safety.
References
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