 |
@CONTENTS@
| Sweeping
Revisions of the |
| Pharmaceutical
Affairs Law |
From time to time, PAJ has been trying, by way of either making
p resentations to the WSMI colleagues or publishing guidebooks,
to introduce the pharmaceutical regulatory climate unique to
Japan.
Listed below are the relevant laws for the control of pharmaceuticals;
- Pharmaceutical Affairs Law
- Pharmacists Law
- Poisonous and Deleterious Substances Control Law
- Narcotics and Psychotropics Control Law
- Cannabis Control Law
- Opium Control Law
- Stimulants Control Law
- Adverse Drug Reaction Suffering Relief and Research Promotion
Fund Law
- Blood Collection and Donation Services Control Law
The Pharmaceutical Affairs Law (PAL), promulgated in 1960, is
the nucleus of the control of pharmaceuticals in Japan and its
major objectives are to ensure the safety, efficacy and quality
of pharmaceuticals. Since its enforcement, PAL has had many
amendments.
In particular, several pharmaceutical accidents occurred in
the 1970s led to the amendment which described strict adherence
to all criteria for drug approval and review pro c e d u res,
including the re -examination and re-evaluation systems for
drugs.
Additionally, an amendment in 1983 made it possible for foreign
companies to acquire direct approval to market their nonprescription
(OTC) medicines in Japan. M o r e o v e r, in accordance with
the results of a Japan-US Market Oriented Sector Selective (MOSS)
Conference held in Tokyo in 1984, some clinical trial data prepared
outside Japan have become acceptable.
PAL is supplemented by Cabinet Ordinances, Ministerial Reinforcement
Regulations, Notifica-tions issued by the then Pharmaceutical
Aff a i r s Bureau of the then Ministry of Health and Welfare
and now by the Pharmaceutical and Medical Safety Bureau (PMSB)
of the Ministry of Health, Labour and Welfare.
Chronologically, back in September 2000, Ad hoc committee on
the Review of Pharmaceutical Administration, formed within the
Federation of Pharmaceutical Manufacturers Associations of Japan,
submitted to PMSB its proposition on Drug Approval and Licensing
Procedures, strongly recommending that the current drug approval
and licensing procedures be thoroughly reviewed and that contract
manufacture, currently limited to a certain range based on the
levels of drug manufac-turing and quality control technologies,
be entirely enlarged.
The bill to revise both PAL and Blood Collection and Donation
Services Control Law had been moved to the Plenary Session of
the House of Representatives for deliberation, which on July
25 gave the nod, which makes it possible to carry out sweeping
revisions of PAL.
The gist of the revisions is;
(a) Shifting from Manufacturing Approval (Authori-zation) to
Marketing Authorization;
(b) Enforcement of Post Marketing Surveillance (PMS) System;
(c) Legal consolidation of Medical Devices into three categories;
Of the above three, (a) should be highlighted since this is
regarded as really a big step, in the long history of the pharmaceutical
administration in Japan, toward the globalization of product
licens-ing procedures popularly practiced in EU, the U.S. and
many other developed countries.
While, in consequence of the PAL revisions, as many as 120 Cabinet
Ordinances, Ministerial Reinforcement Regulations, Notifications
and the like need to be amended or revised as accordingly, the
drug industry has to be fully prepared to comply with the entirely
new requirements, some of which are to be abided by in a year
after the enactment thereof and some in three years. |
| @ |
|
| Revisions
of Blood Collection |
|
and Donation Services Control Law |
| @ |
| Although
this issue may not have direct relevance to the arena of nonprescription
(OTC) medicines, the PAJ Newsletter thought it worth while
sharing this information with our ardent readers.
As background, in the mid 1980s, the Japanese archipelago
shuddered at the various debacles of widespread HIV infection
among hemophiliacs who had been administered un-pasteurized
blood products imported from abroad. The HIV fiasco developed
despite the fact that so many countries had begun using safe
and pasteurized blood prod-ucts by the mid 1980s. It is still
hidden in a veil of mystery why Japan continued to use unheated
(untreated) blood products despite widespread knowledge in
the medical field that the products posed a great hazard.
Immediately following the approval by the House of Representatives
of the bill to revise PAL, a bill stemming from the above
mentioned debacles was approved and the revised law requiring
the state to ensure supplies of safe, domestically produced
blood products was enacted on July 25. The law as amended
stipulates that blood products should be based on blood donate
within Japan and that the government must initiate comprehensive
policies for ensuring stable supplies of safe blood products.
It also grants the government authorities to urg e manufacturers
of blood products to strictly observe and respect the basic
stance of the law. Further it also urges that doctors adequately
use blood products. |
| @ |
|
| PAJ
Held Press Conference |
|
on the WSMI International Events |
| |
With the WSMI 14th General Assembly and 5th Asia Pacific Regional
Conference (WSMI 14th GA & 5th APRC) slated for November being
just around the corner, on July 23, after its 129th Board of
Directors Meeting, PAJ organized its first Pre-WSMI International
Events press conference. To the invitation, some 20 newspapermen
not only from trade journals but also from leading national
newspapers were present.
With a warm welcome, Hiroshi Kumagai, Managing Director, PAJ
Secretariat took the chair.
Akira Uehara, WSMI Chairman (President, Taisho Pharmaceutical
Co., Ltd.), Hachizaemon Kazama, PAJ Chairman (President, Tsumura
& Co.), Yoshihiro Kusai, WSMI 14th GA & 5th APRC O rganizing
Committee Chairman (President, Wakunaga Pharmaceutical Co.,
Ltd.) and Noriaki Shigeno, PAJ Planning Committee Chairman (
D i r e c t o r, Wakunaga Pharmaceutical Co., Ltd.) gave concise
explanations on WSMI, PAJ, WSMI 14th GA & 5th APRC in general,
and the specific programme under the main theme, "Beyond the
Conventional Boundary of Self-Medication Shared Vision, Common
Understandings" respec-tively.
There were vigorous questions raised, all of which were diligently
answered by the four PAJ attendees. The newspapermen's understanding
of and sym-pathy with the objectives of the international events
were favourably reflected in their respec-tive articles which
appeared over a couple of days after the press conference.
|
|
|
|
| A
Bilateral Relationship Matured |
|
between GPFI and PAJ |
|
In September 2001, PA J exchanged MEMO-RANDUM with the Association
of Pharmaceu-tical Enterprises in Indonesia (Pengurus Pusant
Gabungan Perusahaan Farmasi Indonesia or G.P. Farmasi Indonesia).
MEMORANDUM says that GPFI and PAJ will make every necessary
effort to implement the following activities for the mutual
benefits and for promoting responsible self-medication:
(1) Establishing a system for regular and free exchange of information
on the market as well as the regulatory affairs relating to
nonprescription medicines;
(2) Establishing a function to provide coordinative services
to the members of both GPFI and PA J seeking possible business
partners;
(3) Organizing joint seminars and/or workshops on the various
issues of mutual interest and concern;
Conducting other joint activities deemed necessary and appropriate
for promoting self-medication.
Although GPFI was literally a pioneer in hosting the very 1st
Asia Pacific Regional Conference of the then World Federation
of Proprietary Medicine Manufacturers back in 1993 in Jakarta,
it had withdrawn from WFPMM for a certain while and, early this
year, after having completely met the requirements of reapplication
for WSMI membership, blessedly received a very warm welcome
from all other WSMI colleagues as well as London.
To fullfil the above Item (3), the first and quite memorable
joint event was organized in the capital of Indonesia from March
17 through 22.
Highlights of the conference were Information Exchange Forum
on the 18th and GMP Seminar on the 19th. The former provided
attendees with an opportunity not only to get to know each other
but also to freely and openly share information, expertise and
experiences on pharmaceutical regulatory climate, the OTC market
trends and current topics surrounding the OTC industry in both
countries. The latter was planned and conducted by the PAJ GMP
Committee at the ardent request of GPFI who firmly believes
that responsible self-medication can be and should be built
only upon the nonprescription medicines whose safety, efficacy
and quality are established under the rigorous, complete and
systematic manufacturing as well as quality control.
In this sense of the meaning, it was a mutual under-standing
of both parties that Good Manufacturing Practice or GMP becomes
the nucleus of the pharmaceutical control. The point that GMP
must be applied scientifically and rationally, reflecting the
state-of-the-art technical and technological standards and that
every possible effort needs to be made to constantly improve
its level was clearly understood by all the Indonesian attendants
includ-ing, among others, many FDA officials.
Information Exchange Forum, GMP Seminar, factory visits and
other events had been originally scheduled for October last
year, however, all those concerned had no choice but to postpone
them due to the September 11 savageries. |
| @ |
|
| Self-Medication
Promotion Conference |
| |
Self-Medication Promotion Conference Following the concurrence
and approval at the PAJ Annual General Assembly held in May
2001, Self-Medication Promotion Conference was formed in July
last year with the aim of elaborat-ing a strategy to promote
responsible self-medica-tion.
The Conference, consisting of 22 members of executive caliber,
set up the following six major themes for intensive and proactive
discussions:
(1) Positioning self-medication in the framework of the national
healthcare schemes and policies;
(2) Deregulatory measures desirable for enlarging the scope
of nonprescription medicines;
(3) Public relations or publicity on self-medication;
(4) Activities and campaigns for consumer educa-tion and providing
information on responsible self-medication;
(5) Measures to cope with the physical distribution undergoing
violent changes;
(6) Working out a countermeasure for the imminent globalization.
Twice a month starting from July last year, meetings were held
and, at each meeting, two themes each out of these six were
discussed from various angles. The last meeting held in April
this year produced a summary of the nine-month discus-sions,
namely, Action Plans for Implementation, consisting of four
major areas where action plans are suggested for implementation
as soon as practical.
These four major areas are;
(1) Pharmaceutical administration
(2) Interactions with consumers
(3) Interrelations between related business sectors
(4) Globalization
The Suggested Action Plans of these four areas are outlined
below:
(1) Pharmaceutical administration
- Enlarging the scope of nonprescription medicines so as to
include those for improving life style diseases and managing
chronic diseases
- Reviewing INDICATIONS for addressing reada-bility and understandability
by the lay consumers
- Further utilization of natural (herbal) drugs to make themselves
bedfellows with Western (chemi-cal) drugs in recognition of
ingredients scientifi-cally identified through monographs on
medicinal plants
- Promoting Rx-to-OTC switches by way of introducing a totally
new clinical evaluation method, namely, AUT (Actual Use Tests)
to be carried out at the pharmacies with ordinary users as trial
subjects
- Multiplying dose forms (excepting injections and intubating
nutrition which are not in the realm of OTC), reflecting advancement
of preparation and packaging technologies
-Making proposals on simplifying and stream-lining drug approval
and licensing procedures
(2) Interactions with consumers
- Education and enlightenment on self-medication
- Provision of information on correct and proper use of OTCs
for self-medication
(3) Interrelations between related business sectors
- Interactions with bodies such as Self-Medication Advocacy
Council (SMAC: NPO, newly organized in June this year) to explore
ways of extending coordinative services to consumers
- To continue to urge the need of observing OTC Sales Promotion
Code by manufacturers in response to the public trust in OTCs
(4) Globalization
- Stepping up efforts to cultivate long-term international relations
with countries in Southeast Asia whose economy is expected to
outgrow any other regions, placing them in a strong position
to reach the world top level in the first half of the 21st century
- Exploration and study of pros and cons of changing the PAJ
English name into Japan Self-Medication Industry or JSMI in
the wake of precedents (WFPMM to WSMI and PMMA to ASMI)
|
|
|
|
| Report
of the 24th Survey on |
|
Consumer Awareness of OTC Drugs |
|
An advertorial to promote self-medication was conducted on the
Asahi Shimbun, one of the national newspapers, in May. The survey
covered the items such as recognition of the term, "self-medication",
awareness towards importance of self-care, and education at
schools on medicines. The contents and results of the survey
are sum-marized below.
Survey subjects
1,040 (approximately 30% males and 70% females) were randomized
as respondents out of a total of 2,683 applications received
from all over the country.
By occupation, the respondents consisted of 35.8% salaried workers,
38.1% housewives, 1.6% students and 20.2% in other types of
work and unemployed.
Questionnaire included the following seven questions:
(A) How well do you know the term, "self-medi-cation" ?
(B) What do you take into your consideration for maintaining
your own health ?
(C) Do you think you have to take charge of your own health
?
(D) What do you think are essential to self-medication ?
(E) Have you ever been taught about the medicines in the schools
?
(F-1) What is your opinion on the importance of education on
the medicines in the schools ?
(F-2) On what points do you suggest the education should be
given in the schools ?
Results of the survey
(A) How well do you know the term, "self-medication"?
(B) What do you take into your consideration
for maintaining your own health ?
(C) Do you think you have to take charge
of your own health ?
(D) What do you think are essential to
self-medication ?
(E) Have you ever been taught about the
medicines in the schools ?
(F-1) What is your opinion on the importance
of education on the medicines in the schools ?
(F-2) On what points do you suggest the
education should be given in the schools ?
|
Please mark your calendar! The 14th General Assembly
of the World Self-Medication Industry (WSMI) in Tokyo,
Japan 13-15 November, 2002 |
|
|
|
