Premarket Approvals For Pharmaceuticals: Processes And Regulations In Canada And The United States

Choose three out of the following five optional question topics for your exam essay responses

Option 1: Pre-market Approvals for Pharmaceuticals

In your own words, describe in some detail the pre-market approval process for pharmaceuticals from drug development to ultimate approval.  Your readers are non-experts from a cancer survivor’s non-government organization that has been petitioning governments in Canada and the United States regarding the safety and effectiveness of oncology drugs.  Be sure to describe the processes in both countries, including similarities and differences.

Option 2: Pre-Market Approvals for Pesticides and Industrial Chemicals

In your own words, describe in some detail the pre-market approval processes for pesticides and specialty industrial chemicals in Canada.  Your readers are non-experts from a children’s health non-government organization that has been petitioning the Canadian federal government regarding perceived negative effects on children especially vulnerable to chemical exposures.  Be sure to describe the similarities and differences between the two processes.  

Option 3: Post-Market Vigilance for Pharmaceuticals

In recent years, Health Canada and the US FDA have come under criticism for what some non-government health advocacy organizations call lackluster performance regarding post-market vigilance systems for pharmaceuticals.  Describe how these systems work in some detail in both countries.  Your reader is a non-expert, newly hired senior executive of an insurance company that is a client of your employer, a health and safety regulations consulting firm with offices in Canada and the United States.

Option 4: Post-Market Evaluation for Pesticides and Industrial Chemicals

Throughout all OECD countries, thousands of chemicals were put on the market before new chemical notification systems (i.e. pre-market approvals) were established about 20 years ago for pesticides and industrial chemicals.  Most of these chemicals are still used world-wide and yet very little is known about their hazards and risks because they were never thoroughly evaluated by governments. In context of this mix of newer chemicals and older chemicals (i.e. that were and were not subjected to notification systems respectively), describe post-market surveillance efforts in Canada, the United States and the European Union for these two classes of chemicals.

Option 5: Post-Market Recalls

Describe the main requirements and stages for post-market recalls fof pharmaceuticals and pesticide contaminated foods in Canada and the United States.  Give examples to illustrate your points.

The initial pharmaceutical research process

The pharmaceuticals approval process in Canada starts by reviewing the existing pharmaceutical items. The review and the premarket approval process is a straightforward process in Canada. The process lacks complexity, intimidation and frustration (Ramnarine et al., 2017). The Foods and Drugs Act in Canada uses to review and approve the pharmaceuticals premarket permission. The pharmaceutical approval process includes initial pharmaceutical research, preclinical study process, clinical trials, the approval process, the decision making process and the post-approval process (Ramnarine et al., 2017).

This process is started by identifying the chemical and biological substances to develop pharmaceutical items. The identification of chemical and biological systems depends on the information about the identified diseases (Clancy, Weerapana & Thompson, 2016). Moreover, several tests are executed to find out the molecular compounds, beneficial effects and unanticipated treatment process using updated technology. The efficacy and toxicity tests are constructed to measure the safety issue (Clancy et al., 2016).

The preclinical studies include the lab test of the oncology drugs. The identified oncology drugs and drugs are tested on animals and the dead cells (Saip, 2016).  This stage shows the toxicity and seriousness of the pharmaceutical items. Moreover, these lab tests are the outcome of the safety measures perceived in the first stage (Saip, 2016).

All the pharmaceutical items need to go pas the clinical trials. The information gathered in the clinical trials is helpful to outline the relevance of the regulatory dossiers oncology drugs (Fay & Follmann, 2016). The clinical trials are conducted on the humans to review the HPFB process. This process provides information regarding the authenticity of the clinical information, drug effectiveness, safety measures and the best dosage on human beings. Clinical development and clinical trial application are two key implementations of the clinical trial process (Fay & Follmann, 2016).

The clinical development allows the opportunity to choose a new drug session after completing the clinical development plan. The Clinical Trial Application is the mandatory criteria to implement the clinical development plan in Canada with HPFB’s approval (Dholakiya, 2017).

The clinical trial application is a set of documents that include administrative form, protocol summary under the Health Canada’s template, consent form and investigators brochure. The Health Canada notifies the sponsors to submit their application within thirty days if the announcement (Veillard, Tipper & Allin, 2015). The review system includes several questions that require an accurate response. This stage is mainly used to confirm the authorization process and granting permission from the Canadian Ethic Committee.

Preclinical studies

The preclinical and clinical process have al; ready determined the potentials of the therapeutic benefits of the risk assessment. Moreover, the stages have also focused on the required amount of dosage of the oncology drugs (Alany, 2017). During the clinical trials, the sponsors can offer for the NDS that includes pharmaceutical qualities and clinical and preclinical studies. The results of the clinical and preclinical practices are evaluated to find out the risk association of pharmaceutical components (Alany, 2017).

The premarket approval stages of the pharmaceuticals include required information of the NDS application. The application should be submitted on the Common Technical Document (CTD) format (Jordan, 2014). The CTD format includes administrative form, a monograph of the pharmaceutical component, inner and outer labels, product information document, brand name analysis and the risk management plan. The HPFB reviews the NDS process information to evaluate the risks and risks and the existence of risks in the manufacturing of oncology drugs. The evaluation is regulated by The Food and Drug Acts and its Regulations (Jordan, 2014)..

The decision making is a most effective process for the premarket approval of the pharmaceuticals. The notice of compliance, the ineffectiveness of the non-compliance and accelerated review process are three essential component of the decision-making process (Donelan et al., 2015).  The notice of compliance includes the risk management and the dosage confirmation under the Foods and Drugs Act and regulations. The notice of compliance affirms the dealer to take remarket decision to sell the pharmaceutical items (Donelan et al., 2015). If compliance is not perceived properly, the dealer would not be able to sell the pharmaceutical, products like oncology drugs. However, the compliance can be regained by sending more pharmaceutical information to the HPFB. The accelerated review process includes the priority review and compliance and conditions (Shaw & Whitney, 2016). The priority review reclaims the final confirmation of the clinical shreds of evidence and compliance with conditions also requires the clinical evidence through clinical trial phase.

A compliance certificate is not the last parameter to get the selling permission of pharmaceutical items, especially the oncology drugs. After the product approval, HPFB seeks for the sponsor to strengthen the argument that the issued pharmaceutical item is less harmful and is ready to be sold in the market (Sun, 2016).

The sponsor companies of the oncology drugs use to test the components in the laboratory. The lab testing helps to analyze the work efficiency and safety issues of the pharmaceutical items.  A series of tests set to begin to address the amount of dosage of the oncology drugs that can work in the patient’s body (L & Z, 2015). Thereafter the drugs and the other oncological drugs components set out to market for the public test. The CDER evidence is required for the public test. The team of CDER reviews the lab data and establishes an unbiased review regarding the health benefit of the pharmaceutical components (Woodcock, 2014). After the review process risk outweighs are conducted for the final confirmation. The final confirmation with more safety evidence is considered to be the last evidence and the products are sent to the market for selling (Woodcock, 2014).  

Clinical trials

The rules and regulations of both Canada and the USA regarding the premarket approval for the pharmaceutical components go through the same experimental process. This chain of experimental process is universally granted (Croes & de Vries, 2014). Laboratory test, experiment, re-experiment, evidence collection, safety checking and specials review are the common steps used in both the USA and Canada. This lengthy premarket process confirms the products to be safe, usable and less harmful and hence it is granted (Croes & de Vries, 2014). However, the ultimate difference of process between the pharmaceutical premarket approval system in USA and Canada is the decision making process and the post-approval process. The decision-making process in the approval system in Canada is lengthy and it requires more information, shreds of evidence and authentication (Venkatesh & Bandla, 2017). Moreover, it requires further clarification from the HPFB system under the CTD framework. On the contrary, the approval system in the USA only processes in several lab tests and experimental market test with effective safety measures (Venkatesh & Bandla, 2017). In the Canadian approval system, the existence of the post-approval system is valuable. The pharmaceutical products cannot be sold in the market without passing from the post-approval system with integrity. On the contrary, there is no post-approval process in the USA pharmaceutical approval system (Venkatesh & Bandla, 2017).  Laboratory tests, safety checking, quality checking and on-field experimentation are the processes for the USA approval system. To conclude, the Canadian approval system can be considered to be a more authentic drug approval system than the USA.

Ans: The premarket approval process in Canada for the pesticides and industrial chemicals are regulated by Pest Management Regulatory Agencies of Canada (PMRAC). The PMRAC is controlled by the Pest Control Products Act (2002) to manage the industrial chemicals and pesticides (Canada, 2018).  The types of products and pesticides that seek for the premarket approval are insecticides, herbicides, fungicides, rodenticides and bio-pesticides. The approval process comes after the active ingredient review cycle and scientific review process (Yan, 2018). The active ingredient life cycle for pesticides and industrial chemicals include resubmission, submission receipt, screening, science review, decision making, registration and review.  The evaluation of the premarket approval process includes a science review process, risk management decision making, permission consultation, application registers and considerations (Yan, 2018).

The science review process describes the assessment process and risk analysis. The assessment part includes value assessment and chemistry assessment. The risk assessment includes the environmental risk assessment and health risk assessment (Anderson, 2014). The assessment of the value of the pesticides and industrial chemicals states the financial and social value of the component. Thus, premarket evaluation requires the assumptions and expectations. The high financial value of the pesticides impacts on agriculture. Apart from that, chemistry assessment defines the chemical values of the industrial chemicals and its impact on the agricultural fields (Anderson, 2014).

Pharmaceutical items approval process

The environmental risk assessment defines the impact of pesticides and industrial chemicals on the environment. The overuse of the pesticides reduces the fertility of the soil. The industrial chemicals are one of the reasons for water pollution. Thus, PMRA uses to consider the risk assessments and value and chemical assessment as the parameter to approve the premarket registration (Canada, 2018).

The risk management decision making is an effective strategy for PMRAC to provide premarket approval to the pesticides and industrial chemicals. The positive feedback from the risk analysis we help to provide approval easily. The components of the risk management decision making are hazard identification, characterization of risk magnitude, identification of the exposures, and analysis for the risk mitigation and selection of effective risk management strategy.  The identification of the hazards is helpful to expose risks associated to the post-market prediction.  The identification of the risk management strategies to mitigate the risks is the formidable outcome of the premarket approval of the pesticides and chemicals. It is noted that 18% of the household use to consume agricultural pesticides through foods and 28% of the water pollution issues are directed from the industrial chemicals and around 4million people of Canada use to consume insecure foods due to pesticides (Canada, 2018).  Thus, the risk assessment analysis is one of the most valuable processes of premarket approval.

The permission consultation is an opportunity for the premarket approval seekers to gather information regarding the required process for submission and further proceedings. This proves is effective to obtain critically advises about the required protocols (Lennernäs, 2014). It is notable that the pesticides and industrial chemicals are considered to be one of the most threatening food and environment safety issues in Canada. Thus, the shreds of advice form the permission consultation facilitate the progress and review of the screening process and the amount it charges for the further progression of the approval process (Lennernäs, 2014). As per, the rules and regulations of Canada no charge is supposed in the permission consultation process.

The application registration process defines the types of active ingredients for the approval registration process. The application registration process can be separated into two parts; category a registration and category B registration (Chammas, 2015).

The category A registration is specially developed to active ingredients for the premarket approvals in Canada and the use of the registered ingredients for the aquatic uses and terrestrial uses (Chammas, 2015).  The category A registration is the most popular registration between the two registration processes. This registration process does not require a wide number of Pest control products for the registration.

The decision-making process

The category B registration needs to add additional products to the existing pest protocol labels. This registration phase does not include extra charges and directions for the approval does not change frequently (WEBER et al., 2017). Apart from that, the emergency category B registration facility also includes in the premarket approval process.

The emergency B registration process is a minister-level registration process where the minister has the permission to register for the premarket control product for not more than one year. The emergency registration process includes a good number of pest infestations that are the determinants of public health (Richers Maruyama et al., 2016). Moreover, the infestations also include the domestic animals and natural resources for emergency control. The category B emergency registration determines the occurrence of the pest situations having a significant impact on the health-economic and environmental problems (WEBER et al., 2017). However, this emergency approval process is ineffective in emergency pest controlling process and applying any alternative controlling methods.  

Consideration is the final level of premarket approval. This stage includes the processing of the application process and considers the best policymaking. This process considers the aquatic and semi-aquatic process is considered a major new use (Ormerod & Ray, 2016). However, it is also notable that the aquatic products do not have sufficient postmarked demand and it is limited to the terrestrial uses. The ultimate goal of the premarket approval consideration is to eradicate the latest invasive alien species and a long-term investment for the pesticide and chemical manufacturers (Köck, 2015). Hence, the approval for the new use of pesticides and chemicals entirely depends on the business decisions of the approved applicants.

The considerations for the pesticides registrations process is as follows

• The Canadian Honey Council uses to approve the premarket registration of The oxalic and dehydrate pesticides
• The Quebec Cranberry Association uses to approve the 12% of the white vinegar pesticides
• The Ontario Power Generation uses to approve the Wedeco Ozone Generator pesticide

Apart from that, the PMRAC uses to approve both the pesticides and industrial chemicals by providing guidance of legal terms and conditions for the registration (Ormerod & Ray, 2016).

Ans: The post-market recall states the removal of the product from the market after finding its inability for further continuation. The decision making of recall depends on the customer base and product selling ability. In terms of the pharmaceutical recalls the health Canada uses to connect with the distributors and sellers to ensure the recall strategy (Olszewska & Ulatowska, 2013). Moreover, effective communication is developed with the manufacturers and brand owners to confirm the recall standard.

The support from the post-market guidance is essential to initiate the recall process. The customized arrangements for the post-market support our guidance services, health authority correspondence and end to end support. However, the standard decision making for the recall process includes the NHP framework (Henriksen et al., 2014). The NHP framework states to consult with the stakeholders before the recall decision in the cases of specific results and compliances. On the contrary, the HPFB authority needs to consult for the cases of reportable events (Henriksen et al., 2014).

In the cases of food contamination and pesticides, food product safety is considered to be one of the biggest issues. The lack of product safety results in long-lasting illness in Cando. Moreover, the overuse of the pesticides results in the spreading of food contaminated bacteria like bacterium and Listeria monocytogenes (Pietracha & Misiewicz, 2016). The outbreak of the listeriosis is the after effect of the overuse of the pesticides. Reportedly, one of the most prominent food restaurant chains of USAA Chipotle Company stopped selling the food products due to food contamination. The food prices witnessed a great decline form the $750 to $400 ("USDA Food Safety and Inspection Service", 2018). Around $6 billion food value was dropped in the USA due to the food contamination and 14.6% decline in sales. However, the lack of potential to identify any specific formula to address food contamination is considered to be a big reason to recall the products from the market.

Recalls in the food industry is one of inevitable reality. According to the USDA, about 150 food products are recalled every year due to contamination problems.  According to the researchers, there are mainly three reasons of post-market recalls of pharmaceuticals and pesticide-contaminated food product those are mentioned below ("USDA Food Safety and Inspection Service", 2018).

Cross-contamination:  Since the manufacturers manufacture multiple products in a single factory there might occur cross-contamination between the products.  Among the food, product milk causes the most problem as it is sometimes contaminated with diclofenac that causes detrimental effect to the human body (Henriksen et al., 2014). If the allergens are cross-contaminated in the product then the companies should initiate the post-market recall procedure to prevent massive negative effects on the consumers.   For example in 2007 various pet foods in the USA and Canada were contaminated with wheat gluten that resulted in the post-market recall of the product ("USDA Food Safety and Inspection Service", 2018).

Pathogens and pesticides contamination:  Pathogens effected and pesticide-contaminated product causes a huge negative impact on human and animal health consuming the products. Pathogens like salmonella and E coli are the most common reason for the recalls of food products due to the pathogens ("USDA Food Safety and Inspection Service", 2018).

Moreover, Pesticides have high and persistent toxicological effects on the human body and are one of the major reasons for the most market recall of the food product.  For example, in 2015 Bluebell creameries in the United States of America had to recall all of its products including the ice cream, frozen yogurt, frozen snacks due to contamination with Listeria monocytogenes (Pietracha & Misiewicz, 2016).

Physical contamination- Physical contamination is another significant reason for the post-market recall of the food products in the United States and Canada.  If no food and pharmaceutical items are contaminated, it may cause massive damage to the consumers ("USDA Food Safety and Inspection Service", 2018).  For example in USA post-market recall was performed by the Constellation Brand due to glass contamination in Corona extra beer.  

The procedures for the post-market recall for the pharmaceuticals and pesticide-contaminated food in the United States and Canada are as below:

At first, the firm initiates the recall procedure in a prominent manner.  The initiation is done on the basis of the consumers complain about the contaminated product. The overall documentation procedure of the recall is done by the company in an effective manner (Olszewska & Ulatowska, 2013). The documentation is necessary for preparation of the final recall report. Subsequently, a public notification is given that comprises of the reports of the different contaminants. This is done to alert the general people so that they may stop using the food product. The samples of the product are tested by the Food authority agency of the United States and Canada (Olszewska & Ulatowska, 2013). Total health assessment risk report is prepared in a proper manner.  Then the products are literally taken back from the market.  This leads to holistic safety of the citizens from the contaminated food ("USDA Food Safety and Inspection Service", 2018).

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