JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
under a guideline from the MHLW, if an approved clini- cal trial protocol provides for online medical checks in the clinical trial, such medical checks can be con- ducted virtually. 2.5 Use of Data From Clinical Trials Raw data obtained from clinical trials is considered to be sensitive data of clinical trial subjects. There- fore, clinical trial data obtained by a doctor or hos- pitals (investigators) is usually converted into a form that prevents the identities of clinical trial subjects from being discoverable and only such anonymised information or data is provided to the sponsor of the clinical trial. Furthermore, upon commencement of a clinical trial, investigators must obtain an informed consent letter from each trial subject regarding the use and treatment of such subject’s sensitive personal data. This may include consent to disclose the data to a third party involved in the clinical trial. 2.6 Personal or Sensitive Data As mentioned in 2.5 Use of Data From Clinical Tri- als , it is common practice for resulting data to be anonymised, and in such form the data is not regulat- ed as strictly as sensitive data. Disclosure of original, non-anonymised data (raw data) is heavily regulated as sensitive information under the Act on the Protec- tion of Personal Information (APPI). In applying the APPI regulations, data of clinical trial results that “can identify specific individuals through easy matching with other information” (easy matching) is generally considered to be non-anonymised and sensitive per- sonal data. The Federation of Pharmaceutical Manu- facturers’ Associations of Japan issues the Guidelines for the Proper Handling of Personal Information by Pharmaceutical Companies. Such Guidelines note that in order to ensure the reliability of clinical trial data collected by medical institutions conducting clinical trials, pharmaceutical companies may sometimes be required to directly inspect medical records, etc, for monitoring or auditing purposes. Whether or not such inspection by pharmaceutical companies comparing clinical trial data managed by subject identification codes with medical records, etc, falls within the cat- egory of easy matching, is considered to be “consist- ent with the actual situation, and easy matching is recognised when matching is possible regardless of
whether the name, address, etc, is intentionally vis- ible or not.”
3. Marketing Authorisations 3.1 Product Classification The term “pharmaceutical” is defined under the Phar- maceuticals Law as: • items listed in the Japanese Pharmacopoeia; • items that are intended for use in the diagnosis, medical treatment or prevention of disease in humans or animals; or • items that are intended to affect the structure and functioning of a human’s or animal’s body. However, quasi-pharmaceutical products and cos- metics are excluded from the definition of pharma- ceutical. The term “medical device” is defined under the Phar- maceuticals Law as appliances, instruments or similar items that are intended for use in the diagnosis, medi- cal 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 medical 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 Marketing Authorisation for Biologic Medicinal Products To market a pharmaceutical or medical device, the initial marketer is required to obtain marketing authori- sation. Key factors that are taken into account when reviewing an application for marketing authorisation or marketing certification are: • the quality, effectiveness and safety of the pharma- ceutical or medical device; • the applicant’s marketing business licence;
172 CHAMBERS.COM
Powered by FlippingBook