JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
• the manufacturer’s manufacturing business licence; and • the manufacturer’s compliance with the good manufacturing practice (GMP) regulation. Biological pharmaceuticals are generally considered to be proteins or polypeptides produced by the cul- ture 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 component. To obtain marketing authorisa- tion for a biological pharmaceutical, certain additional requirements must be fulfilled, such as: • a manufacturer of a biological pharmaceutical must comply with more stringent management and safety requirements; and • packaging/packaging inserts of a biological pharmaceutical must indicate that it is a biological product. The MHLW believes that in the manufacturing of bio- logical pharmaceuticals, it is important to establish appropriate quality control methods to ensure that the intended clinical efficacy and safety are achieved, and it is necessary to conduct a wide range of quality characteristic analyses as a basis for this. Among the quality characteristics, those that may affect efficacy and safety are managed using a combination of vari- ous control methods, including raw material control, process parameter control, in-process testing, speci- fications and test methods, etc, to ensure that the final product quality falls within the target range. The PMDA and the MHLW emphasise the importance of checking these points when reviewing an application for marketing approval of a biological product. 3.3 Period of Validity of Marketing Authorisations The period of validity of a marketing authorisation is not indefinite. An authorisation for a new pharmaceuti- cal is generally subject to re-examination eight years after the initial authorisation. However, depending on the type of pharmaceuticals, this may be four to ten years after the initial authorisation. Additionally, the MHLW occasionally conducts a re-evaluation of
pharmaceuticals based on the recommendation of its advisory board. A marketing authorisation can be revoked by the MHLW and other competent authorities, when, for example, it is found that: • the relevant pharmaceutical does not have the efficacy or produce the effects indicated in the application; or • the relevant pharmaceutical has no value because the harmful effects associated with such product outweigh the efficacy or beneficial effects. Additionally, a marketing authorisation can be revoked if the responsible party has not marketed the relevant authorised pharmaceutical or medical device for three consecutive years without any reasonable justifica- tion. The MHLW may vary parts of a marketing author- isation for pharmaceuticals and medical devices if, in the MHLW’s view, it is necessary to do so in light of health or hygiene considerations. 3.4 Procedure for Obtaining a Marketing Authorisation Submission of Application An application for marketing authorisation must be submitted to the MHLW or – in the case of certain pharmaceuticals and all medical devices (other than medical devices with a GHTF classification of class IV) – to the relevant prefectural government or a particular registered certification body. With regard to an appli- cation for a pharmaceutical or medical device that must be submitted to the MHLW, the application must be submitted through the PMDA. The MHLW’s review of applications for marketing authorisation for new medicinal products is substantially outsourced to the PMDA. Once the PMDA is satisfied with the applica- tion, the application is forwarded to the MHLW, which then obtains a recommendation from the Council of Pharmaceutical and Food Sanitation before approving the application. Required information A marketing authorisation application must include, as an attachment, data concerning the results of clini- cal trials and other pertinent data – except where the application is for a medicine that is subject to a con-
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