Japan
Question one: Entity that performs reviews
A review of imported and domestic products in Japan is done according to compliance and regulations. Japan Industrial Standards Committee (JISC) carries out the approval process (Berkowitz, 2010). It establishes and maintains standards, carries out certification and accreditation and creates measurement standards.
Question two: Requirements
The requirements include technical regulations and non-mandatory voluntary standards. The dossier contains regulations and standards that help to establish whether an approval should be granted or not.
Question three: Application process
The application process must go through the various stages before an approval can be granted. These stages depend on the nature of technicalities involved the application.
Question four: Review process
The process review or approval involves subjecting products to the Japanese Industrial Standard’s (JIS) mark scheme. Various tests are conducted under this scheme to verify compliance with JIS. Any products that pass the test are given the JIS mark an indication of approval.
Question Five: Issues with Japan
Japan has a high trained scientific expertise that ensures that laboratory testing process for various products comply with the guidelines required. However, the review or approval process usually takes long (Berkowitz, 2010). This has consequently affected most entities that seek to do business in Japan. The long approval process makes it difficult for entities seeking entry into the Japanese market to establish in time.
Question six: Potentiality for pharmaceutical market
Japanese market has a potential for the growth of pharmaceutical industry. The country’s infrastructural development gives it an impetus for the growth of pharmaceutical industry.
Question seven: Analysis of Japanese market reveals a potential for growth in the industry. However, there is need for the expedition of the approval processes to ensure that entities seeking entry into Japan take a short time in the approval process.
Canada
Question one: The Health Products and Food Branch (HPFB) issues approvals in Canada. HPFB scientists review applications to assess the safety and efficacy of drug. The authority regulates and monitors health products.
Question two: Requirements include compliance to regulations and standards.
Question three: The time it takes to carry out review is relative and depends on product that is being submitted as well as the quality of submission. HPFB has performance targets that allow for quality approval process.
Question four: A sponsor expresses interest in a Canadian market and files a new drug submission with HPFB. The latter reviews the information submitted and evaluates safety and quality of data. HBFB reviews information from the sponsor. If the benefits outweigh the risks, a Notice of Compliance is issued alongside Drug Identification Number as indications of approval (Berkowitz, 2010).
Question five: Issues that arise pertains failure of drugs to produce desired effect. This usually raises ethical questions on bioethics. The distributors sometimes fail to inform HPFB concerning studies changes that may take place in the manufacturing process.
Question six: Canada has great potential for pharmaceutical products because of its population and state of the economy. Most people are willing to buy healthcare products.
Question seven: Distributors should take advantage of the vast Canadian market and carry out intensive marketing for their products.
Australia
Question one: Reviews are done by Therapeutic Goods Administration (TGA). This body reviews applications to ensure safety of consumers.
Question two: Distributors are expected to comply with TGA’s standards and regulations before they can be allowed to carry out marketing activities in Australia.
Question three: Like the Canadian case, the duration of approval is not fixed. It depends on the quality of submission.
Question four: Distributes that seek to market health products first submit their applications with TGA. The next step is for TGA to carry out review of applications by use of qualified healthcare scientists (Berkowitz, 2010). The compliance regulations are evaluated to determine qualified applications.
Question five: Even though the benefits may outweigh the risks in some cases, the distributors who qualify for marketing their product sometimes fail to work in consultation with TGA.
Question six: Australia offers a diverse market for pharmaceutical products. This market can help distributors to realize huge profits.
Question seven: TGA should address the ethical issues that may arise from the activities of distributors.
Reference
Berkowitz, E. N. (2010). Essentials of health care marketing. Jones & Bartlett Publishers.
