Regulatory Affairs: Ensuring Compliance & Guiding Corporations - Essay Sample

Introduction

Regulatory Affairs, also named government affairs, is a career within regulated industries such as pharmaceuticals, medical devices, biologics, and functional food. The primary function of regulatory affairs is to ensure, firstly, all the companies in the country conform to all the regulations and laws concerning their businesses. Secondly, working with the federal state and local agencies on particular issues affecting their businesses. Thirdly, guiding corporations on the governing features and climate affecting anticipated activities. In the healthcare sector, regulatory affairs are responsible for creating safe and efficient healthcare products that are made available in the whole world (Mounho et al. 2010). Therefore, regulation involves a thorough examination of a particular drug to ensure the protection of public health. Regulatory affairs achieve this through observing laws on drug registration, import and distribution, and pharmacovigilance.

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Canada is amongst the world's top counties in pharmaceutical innovation. It is the 10th largest market in the whole world and has a share of 2% of the worldwide market (Tobin &Walsh, 2008). While pharmaceutical innovation takes place in many parts of the country, the major industries are in Ontario. Ontario is where almost half of all citizens in Canada work in the pharmaceutical sector. It where significant companies such as Apotex, GlaxoSmithKline, and Johnson & Johnson are situated. The estimation is that there are around 3200 clinical trials in Ontario, Canada, at one time (Mounho et al. 2010). As a key leader in pharmaceutical innovation, Canada takes welfare seriously through companies such as Health Canada and the Federal department, whose main objective is the dedication to the overall health of the Canadians.

Health Products and Food Branch (HPFB) is a branch of Health Canada that plays a significant role in reviewing applications for drugs sold in Canada. It is because for any drug to be legitimately traded in Canada, the company involved must apply to the Health Products and Food Branch to be approved. Thus, during the development of any potential drug in Canada, there are specific steps followed until it reaches the final stage of its approval and marketing. Firstly, when a new drug is developed, it is first tested on small animals or tissue samples to determine its effects and its toxicity. This activity is the pre-clinical testing phase. If the drug proves to safe and highly beneficial to use during the pre-clinical testing phase, the findings are compiled and submitted to the Health Products and Food Branch by the representatives of the specific company. What follows is the reviewing of the information by the Health Products and Food Branch and then making judgments for the approval of the new drug for the next phase, which is human trials.

The clinical trial phase is when human trials are conducted. For each clinical trial, a progress report is presented to the Health Products and Food Branch to be reviewed. It ensures that safety prevails in the clinical trial phase. The most effective and safest drugs are allowed to progress to the next stage. After a thorough examination and testing of the new drug and its results have proved to be more beneficial through distinctive clinical trial phases, its manufactures then file a New Drug Submission. The developers of the new drug submit the Health Products and Food branch, and it comprises, firstly, the outcomes of the pre-clinical and clinical phase trials, whether conducted in Canada or other counties. Secondly, specifics associated with drug production. Thirdly, packaging, and labeling of the new drug and lastly, data that shows the consumers therapeutic claims and side effects of the drug (Theisz, 2015). After the review of this particular submission by the Health Products and Food Branch, the company developing the new drug is granted permission to allow the selling of the new drug in the Canadian market.

Regulatory Affairs, therefore, play a crucial role in aiding the newly developed drugs in reaching the Canadian market (Morgan et al. 2006). It is because of the hard work and commitment standards set by Health Canada. It ensures that the drugs manufactured in Canada or imported are safe to use by the Canadians. The Regulatory Affairs professional has many responsibilities in the course and development of a new drug when undergoing development. In the first stage of research and discovery, a regulatory professional ensures that the proposed drug conforms to the international regulatory agency requirements and has a target market in mind. It also includes plans that consider the notion of expanding the development of drug usage geographically.

Secondly, in the second stage of pre-clinical research, the regulatory affairs officer ensures that the quality of the drug proposed meets both the local and international requirements before a first-in-man study. The pre-clinical phase is critical to the regulatory affairs officer; therefore, the research conducted should be thorough, detailed, and offer a keen logistical ability (Cutler, 2002). Thirdly, in this stage, which consists of clinical trials, the function of a regulatory officer are many. They include; coordinating pre-submission meetings, performing effective and strategic medical and regulatory writing, performing questions and answers, reviewing submission documents for local and international compliance, preparing submissions to the Health Authorities, and ensuring regulatory interface with the developers during preparation.

In the fourth stage, which includes the regulator process and approval for market access, the regulatory affairs professional aids in providing support and knowledge needed during each step of the registration process. The major areas that the company developing the new drug need assistance include; successful navigating the submission preparation, identifying potential problems that arise ahead of the submission period and consequently, providing solutions to the specific issues. In this phase, the regulatory affairs professional conduct various activities. The activities are performing efficient and strategic medical and regularity writing, conducting question and answers exercise, reviewing documents for completeness as well as local and international compliance, interfacing with health authorities, and making the regulatory process more predictable until the approval of the drug.

When the registration process is complete, and the drug is accessible in the Canadian market, the regulatory affairs officer is the point of contact with the Health Authorities (Kondro & Sibbald,2004). It is to ensure that the company that developed the drug maintains the compliance behind maintaining a registration. After the approval for the drug to be availed in the market, the Regulatory Affairs officer will have many responsibilities. The responsibilities are pharmacovigilance, activities that comply with the guidelines, evaluate the type of variations expected after approval of the new drug, documents required, and preparing and coordinating all activities pertaining post-approval submissions to Health Authorities and organizing communications about the drug with the Health Authorities.

Conclusively, Regulatory Affairs is an essential element in the drug making in Canada. Their officers are essential to the process because of the overall activities they engage in making judgments about the safety and effectiveness of the new drug. Thus, more students should be encouraged to take courses in Regulatory Affairs to promote this vital career to the government of Canada. Additionally, for the safety of the citizens of Canada, any company engaging in the selling of drugs illegally should be reported immediately. The consequences for illegal selling of the drugs should be adverse to prevent other companies from flooding the Canadian market with drugs that have not been scrutinized by the Health Products and Food Branch and a representative of the Regulatory Affairs. Therefore, during the development of a new drug, regulatory affairs must be notified due to their expertise.

Reference

Kondro, W., & Sibbald, B. (2004). Pharmaceutical Industry: Drug company experts advised staff to withhold data about SSRI use in children. CMAJ: Canadian Medical Association Journal, 170(5), 783.

Mounho, B., Phillips, A., Holcombe, K., & Grampp, G. (2010). Global regulatory standards for the approval of biosimilars. Food & Drug LJ, 65, 819.

Tobin, J. J., & Walsh, G. (2008). Medical product regulatory affairs: pharmaceuticals, diagnostics, medical devices. John Wiley & Sons.

Theisz, V. (2015). Medical device regulatory practices: an international perspective. CRC Press..

Morgan, S. G., McMahon, M., Mitton, C., Roughead, E., Kirk, R., Kanavos, P., & Menon, D. (2006). Centralized drug review processes in Australia, Canada, New Zealand, and the United kingdom. Health Affairs, 25(2), 337-347.

Cutler, D. M. (2002). Equality, efficiency, and market fundamentals: the dynamics of international medical-care reform. Journal of economic literature, 40(3), 881-906.