JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
• a manufacturer of a biological pharmaceutical must comply with more stringent manage- ment and safety requirements; and • packaging/packaging inserts of a biologi- cal pharmaceutical must indicate that it is a biological product. The MHLW believes that in the manufacturing of biological pharmaceuticals, it is important to establish appropriate quality control meth- ods 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 various control methods, including raw material control, process parameter control, in-process testing, specifications 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 mar- keting approval of a biological product. 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices The period of validity of a marketing authorisa- tion is not indefinite. An authorisation for a new pharmaceutical is generally subject to re-exam- ination eight years after the initial authorisation. However, depending on the type of pharma- ceuticals, this may be four to ten years after the initial authorisation. Additionally, the MHLW occasionally conducts a re-evaluation of phar- maceuticals 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 benefi- cial effects. Additionally, a marketing authorisation can be revoked if the responsible party has not mar- keted the relevant authorised pharmaceutical or medical device for three consecutive years without any reasonable justification. The MHLW may vary parts of a marketing authorisation 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 for Pharmaceuticals and Medical Devices 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 clas- sification of class IV) – to the relevant prefectural government or a particular registered certifica- tion body. With regard to an application 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 authorisa- tion for new medicinal products is substantially outsourced to the PMDA. Once the PMDA is satisfied with the application, the application is forwarded to the MHLW, which then obtains a recommendation from the Council of Pharma- ceutical and Food Sanitation before approving the application.
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