Economic
and Legal Frameworks
for Non-Prescription Medicines 2004 studied by AESGP
13.
SWITCH CLIMATE
The registration procedures
for non-prescription medicines explained in point 2 (Registration)
apply exactly and in the same measure to Rx-to-OTC switch
application dossiers. However, in 1998 some additional
suggestions were made at a meeting of the Non-prescription
Medicines Special Committee of the Central Pharmaceutical
Affairs Council (CPAC) of the MHLW. These suggestions
can now be considered as additional guidelines applicable
to Rx-to-OTC switch applications and state that:
a.
The active ingredients
presented for switching shall have undergone either
"Re-examination" or "Re-evaluation."
b.
The
review of Rx-to-OTC switch application dossiers
will have to be conducted upon taking into serious
consideration the CPAC opinions so as to determine
whether the application is appropriate as a non-prescription
medicine.
A rate of incidence of adverse medicine reactions, administration and dosage,
actual examples of use of the medicine in foreign countries, results of either
re-examination or re-evaluation, etc., are also to be taken into consideration.
c.
In order to ensure the appropriate
use and safety of the medicine, certain conditions
will be imposed at the time of approval such as
the obligation to conduct post-marketing surveillance
(PMS); directions on information provision, where
deemed necessary; sales (retailing) methods; and
advertising standards.
d.
At the
time of approval, the switched medicine shall
be "a designated medicine" which cannot be distributed
by a person having obtained Yakushusho-hanbai-gyo
(see 7 (Distribution)).
e.
After approval, PMS is to be
conducted for a specified period of time (three
years, in principle) in accordance with the PMS
Implementation Plan.
One year after launching, the results of PMS obtained so far must be compiled
into a report for submission to the CPAC, which will then review the conditions
for approval, approved details, etc., taking into consideration the opinions
of its members.
In line with the additional
basic policies, MHLW formed an Ad Hoc Working Group,
as part of the Welfare Science Study Programme with the
official assignment of carrying out an "Investigative
Study on the development and assessment of New Non-Prescription
Drugs." The Working Group's main task was to identify
appropriate clinical trial methods as well as effective
ways of conducting PMS in order to collect the data necessary
for developing and assessing Rx-to-OTC switch candidates.
In April 2000, the Working Group issued its report, which
can be summarised as follows:
Pharmacists
are to conduct clinical trials with pharmacy
visitors. These are called "Actual Use Trails"
or AUTs.
Prior to conducting
AUTs, a survey is to be made to determine how
the possible subjects of clinical trials understand
the meaning of clinical trials.
As for
PMS, two kinds of surveillance are to be conducted:
Surveillance
of hazards / adverse reaction recorded
for a certain period after a
product's launch
Surveillance
of the actual use / administration of
trial drugs by the subjects.
After the first pilot study of AUT under the auspices
of The Japan Pharmaceutical Association (JPA) and The
Japan Self-Medication Industry (JSMI) in March 2001,
the Japan Self-Medication Industry carried out a second
AUT study with the support from JPA in January to March
2005. This time, four preparations for cold remedies
containing ibuprofen were considered. A total of 300
cases are expected to be examined.
The results from these studies could help the Ministry
of Health, Labour and Welfare endorse the AUT concept
to replace the current "5-medical institutions / 150-cases"
requirement.
Although the same trademark can be used for the prescription
medicine and for the switched medicine, each product
name must be clearly recognised as different.
Active ingredients switched from Rx to OTC status in
the last few years include:
