JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
in order to ensure the reliability of clinical trial data collected by medical institutions conduct- ing clinical trials, pharmaceutical companies may sometimes be required to directly inspect medical records, etc, for monitoring or audit- ing purposes. Whether or not such inspection by pharmaceutical companies comparing clini- cal trial data managed by subject identification codes with medical records, etc, falls within the category of easy matching, is considered to be “consistent with the actual situation, and easy matching is recognised when matching is pos- sible regardless of whether the name, address, etc, is intentionally visible or not.” 3. Marketing Authorisations for Pharmaceuticals or Medical Devices 3.1 Product Classification: Pharmaceuticals or Medical Devices The term “pharmaceutical” is defined under the Pharmaceuticals Law as: • items listed in the Japanese Pharmacopoeia; • items that are intended for use in the diag- nosis, medical treatment or prevention of disease in humans or animals; or • items that are intended to affect the struc- ture and functioning of a human’s or animal’s body. However, quasi-pharmaceutical products and cosmetics are excluded from the definition of pharmaceutical. The term “medical device” is defined under the Pharmaceuticals Law as appliances, instru- ments or similar items that are intended for use in the diagnosis, medical treatment or prevention of disease in humans or animals – or that are
intended to affect the structure or functioning of the bodies of humans or animals – and that are specified by cabinet order. The relevant cabinet order specifying medical devices is so broadly worded that it is not clear whether each and every medical appliance, instrument or similar item is classified as a medi- cal device. Software that is intended for use in the diagnosis, medical treatment or prevention of disease in humans or animals can also be classified as a medical device. 3.2 Granting a Marketing Authorisation for Biologic Medicinal Products To market a pharmaceutical or medical device, the initial marketer is required to obtain mar- keting authorisation. Key factors that are taken into account when reviewing an application for marketing authorisation or marketing certifica- tion are: • the quality, effectiveness and safety of the pharmaceutical or medical device; • the applicant’s marketing business licence; • the manufacturer’s manufacturing business licence; and • the manufacturer’s compliance with the good manufacturing practice (GMP) regulation. Biological pharmaceuticals are generally consid- ered to be proteins or polypeptides produced by the culture of recombinant or non-recombinant cell protein expression systems, highly purified, and characterised by a range of appropriate analytical methods, as well as derivatives thereof or pharmaceuticals containing them as a com- ponent. To obtain marketing authorisation for a biological pharmaceutical, certain additional requirements must be fulfilled, such as:
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