Your Strategic Partner forJapanese Market Entry

The Japanese market is growing and changing

2ndlargest
marketin the world for prescription
medications and per capita
drug spending

New options
for drug

Fasterdrug
approval

pricingpremiums
reward innovative
medicineby PMDA than the FDAand EMA from 2014
to 2016*

Favorable
regulations
for regenerative medicine
through conditional/
term-limited authorization

morethan 25%of its
population
now over the age of 65; Central
Nervous System and Oncology
therapies are growing

Although quality and innovation standards in Japan are comparable to that of the U.S.
and European markets, the Japanese market can hold many regulatory and lingual
obstacles for the first-timer. As Japan’s first CRO, CMIC is your most experienced
partner in Japan. Let our experts guide you in navigating the market.
*Bujar M, McAuslane N, Liberti L. 2017. R&D Briefing 62: New drug approvals in ICH countries 2007-2016. Centre for Innovation in Regulatory Science.

Tailor our services to meetyour Japanese market entry needs
CMIC provides end-to-end solutions for market entry into Japan. Our 50+ experienced consultants will help you
determine the best strategy in accordance with Japan-specific changing regulations and unique environment, working
flexibly with your company’s plans for market entry. We provide options for entry at any stage in drug development:
before clinical trials have started abroad, after approval abroad or after commercializing in a different country. As a
Pharmaceutical Value Creator, CMIC strives to provide value by spanning our services across the entire drugdevelopment value chain.

Featured services for Japanese market entry
PRE - CLINICAL

CLINICAL PHASE I - III

POSTAPPROVALAPPROVALICCC servicesMAH related services* An In-Country Clinical Caretaker (ICCC)
is required for foreign companies toconduct trials in Japan.

* A licensed Marketing Authorization
Holder (MAH) is required for obtaining
approval and marketing in Japan.

Consultation services for market entry
Establish a company in Japan: Solutions for establishing a presence in Japan.
Out-Licensing to other pharma: Partnering services as an add-on option.

Laboratory

Regulatory Affairs

Regulatory Affairs• Pre-clinicaldata gap analysis• PMDA consultations & Clinical
Trial Notification (CTN)
submissions• CTD preparation,
submission &correspondence• Inspection support &interpreter services• National Health
Insurance (NHI)
reimbursement pricing
and consultation

Investigational Product
Manufacturing• Investigational Product visualinspections, packaging &labeling per Japanese
regulations

Medical Affairs• Medical affairs organization
setup, consultation &resources for Japan

Post Marketing
Surveillance& Clinical Research• Post Marketing
Surveillance services

Commercial Supply• Visual inspections,packaging & labeling per
Japanese standards

Sales and Marketing• Commercial planning,
setup and resources forJapan

Contract
R esearch
Organization
Experienced non-clinical,
clinical and regulatory
research & development
solutions

C ontract
Development &Manufacturing
Organization

Innovative
PharmaModel
A flexible service
platform providing full
pharmaceuticalcapabilities for overseas
business partners toenter Japan

PharmaceuticalValue Creator

Quality solutions forformulation development,
analytical testing,manufacturing andpackaging

A business model of comprehensive
services creating added value frompreclinical to commercialization

Healthcare
Business
Patient and consumer
support programs,
and clinical sitemanagement
for hospitals andmedical institutions

CMIC GroupEMAIL : information@cmic.co.jp WEBSITE : www.cmicgroup.com/e© CMIC HOLDINGS Co., Ltd.

Contract
Sales
Organization
Broad medical affairs,
sales and marketing
solutions