JIN-272 -- GUEST EDITORIAL -- E-books, Cellphone Novels and the Long Ride Home

J@pan Inc Magazine Presents:

T H E J @ P A N I N C N E W S L E T T E R

Commentary on the Week's Business, Technology and Cultural News
Issue No. 272
Wednesday, April 28, 2004

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[**This week we present a guest editorial by Bruce Rutledge -- J@pan
Inc's previous editor in chief.

Rutledge is now the President of Chin Music Press
(http://www.chinmusicpress.com/), a publishing house based in Seattle,
Washington. Chin Music will release its first title, KUHAKU,
in late May. KUHAKU is an edgy and eclectic collection of musings on
today's Japan -- far from the headlines -- and features contributions
from writers worldwide.

For us, Rutledge comments on the e-book phenomenon, cellphone novels,
and the good old analog BOOK.]

@@ VIEWPOINT: GUEST EDITORIAL -- E-books, Cellphone Novels and the Long
Ride Home

>> PLUS: Streamlining Japan's Pharmaceutical Industry

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@@ VIEWPOINT: E-books, Cellphone Novels and the Long Ride Home

A reporter recently asked me whether I thought e-books were a threat to
traditional publishers. "No, not yet," was my reply.

Obviously, Sony disagrees.

Sony became the latest company to try to revive the market for e-books
when it released its Librie reader on Saturday. The reader uses cutting-
edge electronic-ink technology from Boston-area E Ink that creates clear,
easy-to-read text even in sunlight.

I致e seen this technology: It痴 amazing. You can tilt the screen any way
you want, and the text remains clear. But does that mean Japan's readers
are going to flock to it?

I doubt it.

Sony and its partners are banking on the idea that consumers will shell
out 41,790 yen for the reader and rent books for 60 days from Timebook Town
at 315 yen a pop. Perhaps. But the whole concept seems counterintuitive.
Book lovers like to have books around so that they can reread a favorite
passage or lend a volume to a friend. If they're going to save money,
they can head to the library. Renting an e-book seems like an unnecessary
and unfulfilling compromise.

Advocates of e-books argue that Japan already has more than 50 million
mobile readers, many of whom have long commutes home. E-books are a natural
fit, they say. Sony has carefully tried to create a book-like reading
experience, making its reader the same weight as the average Japanese
book, according to the Guardian article.

Advocates also point to a recent Weekly Yomiuri article that says the
return of e-books -- Matsushita is also hawking its Sigmabook reader --
could lead to more substantial digital libraries in Japan. That would be
a very good thing for researchers, academics, reporters and anyone else
trying to access information remotely, but it's not enough to make me
run out and get an e-book reader. This new push for e-books just reeks
too much of manufacturers trying to move product regardless of consumer

Contrast the 40,000-yen reader with the cellphone novel, which is free
and seems to be everywhere these days. Cellphone novels are novels
written in short, usually 1,600-character installments, making them
easy to read on a cellphone screen. The granddaddy of cellphone
novels, 泥eep Love・by Yoshi (he only uses his first name), was turned
into a traditional book and then a movie, which is playing in Tokyo
theaters now.

Sure, you may have to wade through a whole lot of bad cellphone novels
before you find a good one. But somehow, searching for them on your
keitai seems a lot more exciting than reading an electronic version
of a book on Sony's shiny new reader.

-- Bruce Rutledge


Guardian article about Sony痴 Librie

Sony's Librie page (in Japanese)

A sample cellphone novel (in Japanese)

Info on the movie "Deep Love" (in Japanese)

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>> Streamlining Japan's Pharmaceutical Industry

Japan's Ministry of Health, Labor and Welfare (MHLW) is undertaking
major regulatory reform based on the revised Pharmaceutical Affairs Law
(PAL) under which it has established the Pharmaceutical and Medical
Device Agency (PMDA) -- a new agency to conduct reviews of medical devices
and pharmaceuticals -- on April 1, 2004. PMDA was formed from the merger
of the Pharmaceutical and Medical Device Evaluation Center (PMDEC), the
Organization for Pharmaceutical Safety and Research (OPSR) and the
Japanese Association of Advanced Medical Equipment (JAAME).

Under PMDA, services provided by these organizations, including product
approval reviews, were consolidated. However, MHLW retains the power for
final approval of drugs and medical devices. It is expected that the
creation of PMDA will speed up the process within the Japanese
pharmaceutical and medical device administration system, ensure higher
quality administrative services and enable the system to adapt to the
new challenges of the bio-genomic age.

PMDA's Objectives:

(1) Adverse Drug Reaction (ADR) Relief:
> Compensation (medical care and pensions) for disease, injury
or death related to either adverse drug reactions or infections arising
from biological products.
(2) Review and Related Operations:
> Approval review of drugs and devices under the PAL.
> Guidance and advice regarding clinical trials.
> Good Clinical Practices, Good Laboratory Practices, and Good
Manufacturing Practices audits.
(3) Post-Marketing Safety:
> Collection, analysis, and provision of safety information.
> Promotion of safe use of drugs and devices.
(4) R&D Promotion:
> Basic research for drug technologies and "promotion of the

Review and Related Operations:

At PMDA, one team conducts both clinical trial consultations and product
reviews so that PMDA can provide consistent instructions to applicants.
PMDA will provide applicants with opportunities to consult throughout
the clinical trials process. There is a greater variety of
consultations on clinical trials than in the past. Once an application
has been filed, there will be a first meeting between the applicant and
the reviewer, including an explanation of the application's content.

After that meeting, reviewers will meet within the PMDA with an expert
panel. Then a series of questions will be submitted to the applicant.
If the answers to the questions are not sufficient, there will be an
interview review meeting attended by the applicant, reviewer and outside

By March 2006, PMDA plans to increase the number of reviewers to 260
from 170. PMDA is planning to approximately double the number of
medical device reviewers from the current less than 20 and also to
double the number of drug reviewers from the current 70. Other
reviewers will focus on OTC, generics, GMP and GCP.

PMDA intends to employ reviewers well-versed in the basics: clinical
trials, biological statistics.

PMDA's Review Divisions:

> Review management department
> New drug review department 1
> New drug review department 2
> New drug review department 3
> Bio-derived products review department
> OTC drug review department
> Medical device review department
> Reliability/quality control department

PMDA's Contact Information:

Pharmaceuticals and Medical Device Agency (PMDA)
Shin Kasumigaseki Bldg.
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013
Website: http://www.pmda.go.jp
Chief Executive: Akira Miyajima

-- Gordon Feller

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Written and edited by Roland Kelts and
Leo Lewis (editors@japaninc.com)


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