Premarket approval of Pharmaceuticals PDF

Submission Evaluation

Table of Contents
1.Premarket approval of Pharmaceuticals......................................................................................2
2. Premarket approval for pesticides and industrial chemicals........................................................7
5. Post-market recalls.....................................................................................................................11
Reference list.................................................................................................................................15
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1.Premarket approval of Pharmaceuticals
Ans: Premarket approval of pharmaceutical in Canada
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).
The initial pharmaceutical research process
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).
Preclinical studies
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
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and seriousness of the pharmaceutical items. Moreover, these lab tests are the outcome of the
safety measures perceived in the first stage (Saip, 2016).
Clinical trials
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.
Pharmaceutical items approval process
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
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