Global Regulatory Pulse

New Marketing Application Procedure for Combination Products in Japan

In Asian Market, Consulting, Regulatory by Akira Toyama

Combination products are products consisting of two or more pharmaceutical drugs and medical devices. These products are expected to fall under the category of drugs, medical devices, or cellular and tissue-based products if marketed individually (hereinafter referred to as combination products). Due to the implementation of Revised Pharmaceutical Affairs Law, the following notifications have become effective: Handling of Marketing Application for Combination Products (PFSB/ELD Notification No. 1024-2, PFSB/ELD/OMDE Notification No. 1024-1, PFSB/SD Notification No. 1024-9, PFSB/CND Notification No.1024-15).

Classification of combination products include:

  • Set products which consist of individual drugs that can each be marketed individually as a drug, medical device, or cellular and tissue-based product;
  • Kit products specified in PAB/ELD Notification No. 2-98; and
  • Products in which the constituting drugs is unable to be marketed individually (excluding kit products).

Additional classification of combination products includes:

  • Products which contain medical devices for puncture and external disinfectants used as a drug for disinfecting the skin at the puncture site that are combined and packaged together and sterilized according to PFSB/ELD/OMDE Notification No. 0331002;
  • Products which contain marketed drugs, medical devices, or cellular or tissue-based products that are sold together by distributors and are handled according to Handling of combination drugs etc. (PMSB/IGD Notification No. 104); and
  • Drugs approved for integral marketing with devices specified in article 98-2 and article 228-20-3 of “Medical Devices Approved for Integral Marketing with Drugs”, article 114-60-2 and Cellular and Tissue-based Products Approved for Integral Marketing with Devices etc.”, and/or article 137-60 of Ordinance of the Ministry of Health and Welfare No.1 of 1961.

Products are individually judged as to whether they fall under the category of drugs, medical devices, or cellular and tissue-based products by taking their primary function and purpose into consideration.

Examples of combination products classified with drugs include prefilled syringe injections, injections with injector pen with adjustable dosing system, and asthma agents with inhaler with adjustable respiratory intake system.

Examples of combination products classified with medical devices include drug-eluting stents, heparin-coated catheters, and antibacterial bone cements.

Examples of combination products classified with cellular and tissue-based products include cell suspensions in pre-filled syringes and a set of products of cell suspension and scaffolding used by impregnating at clinical settings.

Authors:

Akira Toyama received an M.S. degree in Microbiology from Eastern Washington University. He received a Ph.D. in Molecular and Cellular Biology from University of Southern California, and completed an NIH postdoctoral fellowship in the field of Cardiology and Regenerative Medicine at University of Minnesota Lillehei Heart Institute. Since 2015, he has been at NAMSA and currently works as a Medical Research Manager with primary focus on clinical and consulting work in Japan’s medical device industry.