Evaluate the information for the indication being sought for registration

• Evaluate the information for the indication being sought for registration• Identify limitations in data (if present)• Raise potential questions that might be addressed to either the sponsor (pharmaceutical company) or referred to an advisory committee for specialist advice• Indicate if all, some or none of the indications sought by the company should be granted and why?(2). If registration is to be granted, discuss the following:• The indications the chemical entity can be used for in treatment or management of a condition.• Population (e.g. only adults, caution in children, not to be used in pregnancy after 1st trimester)• Conditions (e.g. hospital use only, physicians need to report on specific adverse reactions that have a high likeness of being a problem, prescription only)• Risks (e.g. high probability of addiction, allergic potential or likely drug reaction with other medications used to treat same condition)• Possible concerns not able to be clearly identified from available data (these might be conditions in a pharmaco vigilance plan where insufficient clinical data available)• Specific requirements for dispensing (e.g. cold chain storage issues, limited shelf life, photosensitivity, dosages, amount to be released and number of repeats or delivery (e.g. where the product is an injectable form)• Any special supervision requirements (e.g. cytotoxic substances given only by trained clinical staff).• Consumer affairs issues (potential for confusion when or how to take medication).(3). If registration is not to be granted, discuss the following:• What concerns need to be addressed before submission be considered further?• Risk versus benefit unacceptable (e.g. a cytotoxic drug where severe adverse reaction(s) significantly decrease the quality of life with little or minimal prolongation of life)• Significant interaction(s) with other medications required for management of condition likely (e.g. medication which reacts with all anticoagulants needed for patients with chronic heart conditions)Page 10 of 12 Version: BMSC303, Sem 1 2021• Clinical data for population that would use medication insufficient to make a balanced decision (e.g. medications developed for use in late in pregnancy where conflicting information exists for safety)• High potential for development of substance abuse which can’t be control by adequately by inclusion of any available conditions on use• High or unacceptable risk for use because or risk of infection or spread of infection (e.g. some pharmaceutical products have been developed using a latent viral vector to deliver a vaccine or target a specific infection where uncertain risk of the vector mutating to wild type).• Uncertain effect with possible unexpected infection or organ damage (e.g. use of a bacteriophage specific for Pseudomonas spp. in cystic fibrosis patients)

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