1.A Scheme to expedite granting Rx-to-OTC Switch was approved
On March 22, Thursday, the Committee on Nonprescription Drugs in the Pharmaceutical Affairs and Food Sanitation Council (PAFSC) of the Ministry of Health, Labour and Welfare (MHLW) deliberated on and approved a draft proposal titled "Switching of active ingredients used in prescription medicines into use for nonprescription medicines".
In the existing conditions, approval of Rx-to-OTC switched drugs, of which active ingredients was originally used for prescription drugs and is converted its use for OTC drugs, is made judgments by examining individual drug products based on submitted application by pharmaceutical companies. Regrettably, however, the Rx-to-OTC switch itself has not been smoothly achieved. In an attempt to alleviate the retardation, the draft was proposed to institute a scheme where expertise as to the appropriateness for Rx-to-OTC switch of some suggested active ingredients is sought from the academia involved and the expertise is referred to discussion and publication by the PAFSC. All in all, the proposed scheme aims at promoting the Rx-to-OTC switch with striving toward transparency in the examination procedures. The scheme is due to be implemented every year from 2007 onward, with its actual implementation details being revised as deemed necessary, reflecting the prevailing situation. The concrete procedures for implementation of the scheme are as follows:
(1)
The academia related to pharmaceuticals will be entrusted with a task to summarize the assessment for applicability of the suggested active ingredients focusing on efficacy and safety and the grounds considered to be appropriate for the application of them to Rx-to-OTC switch.
(2)
The summarized information shall be publicized and presented to the healthcare professionals of academic society in medical field to inquire appropriateness for switching those ingredients to OTC use.
(3)
Taking the summarized information and the expertise provided by the academia involved into account, the PAFSC deliberates adequacy to Rx-to-OTC switch of those ingredients and shall be publicized.
Besides the above procedures, the following matters have also been announced:
(1)
The scope of the data required for an application of the OTC drug which contains the active ingredient publicized by the scheme shall be, in principle, same as the scope of the data currently required of Rx-to-OTC switch applications.
(2)
As for granting approvals to individual drug products, the opinions of the PAFSC shall be taken into consideration in the same manner as conventionally done.
(3)
The active ingredients other than those publicized by the scheme shall not be concluded as inappropriate for the so-called Rx-to-OTC switched drugs. Arguments about the pros and cons on individual products shall be continuously done based on the data submitted.
This new scheme proposed to expedite granting Rx-to-OTC switch is the fruits of the regularly organized meetings between the high-ranking government officials at the competent authorities and the Strategic Alliance Conference for Business Promotion (SACBP) of the JSMI which put the scheme on the top of the agenda. The JSMI has been striving for achievement of its objectives such as establishment of transparency in the examination procedures for Rx-to-OTC switch applications, publication of the candidate active ingredients for switching, and concrete scheduling of the implementation. These objectives appear to have finally begun materializing, but, at this juncture, it would be appropriate for the JSMI to remind itself of the significance of closely watching the administrative actions in the area of, among others, tabulation of the candidate active ingredients for switching. It is indeed encouraging that the approval of the draft scheme has paved the way for promoting Rx-to-OTC switch. At the same time, the JSMI should continue to commit itself for solving certain obstacles in question associated with the development of Rx-to-OTC switched drug such as obtaining consent from the manufacturers holding the exclusivity to the drug products/active ingredients.
(1)
We would request that the examination system for OTC Medicines be strengthened by increasing officials in charge of examination and by other measures, and that the adherence to the specified time limit required for examinations be encouraged.
(2)
We would request that development of Rx-to-OTC switches, introduction into Japan of Western herbs commonly used as medicines overseas, and studies of new indications of OTC Medicines which reflect an epidemiological shift in disease patterns be materialized. We would further request that the conventional paradigm be not stuck to when such materialization is contemplated.
2.Regulatory gate is opened to development of Western Herbal Medicines as OTC drugs.
On March 22, the Committee on Nonprescription Drugs in the Pharmaceutical Affairs and Food Sanitation Council (PAFSC) of the Ministry of Health, Labour and Welfare (MHLW) deliberated on and approved rules how to apply to licenses of Western Herbal Medicines as OTC drugs in Japan.
Following the approval thereof, on the same date, the Director of the Evaluation and Licensing Division issued Notification titled "Handling of Applications to OTC Drug Manufacturing/Distribution Approval for Natural Drug preparations which have been widely used as OTC Drugs in the foreign countries".
The gist of the Notification is as follows:
Incidentally, the term referred to as "the foreign countries" means "either the countries that have in place the drug approval and licensing systems considered to be on a level with those in our country or the countries that have in place the drug approval and licensing systems considered to be equivalent to those in our country".
1. Classification according to conditions in the application
Shoyaku-seizai (Natural Drug preparations) containing an active ingredient which has never been used in the already approved medicines shall be classified as "CLASS 1: Drugs containing new active ingredients"
2. Data required for Application for Drug Manufacturing/Distribution Approval
(1)
Concerning clinical trials, for the Shoyaku-seizai (Natural Drug preparations) which fall into either one of the following applications, there are cases where the judgment as to whether to grant an approval or not can be made upon submitting the results of the clinical trials designed mainly at confirming the safety of the Japanese trial subjects.
- for the applications which are able to obtain and submit accurate and objective results of the comparative controlled clinical trials which have been conducted, under the same condition in terms of efficacy or indications, and administration & dosage, using the preparations considered to be equivalent in quality to the Shoyaku-seizai (Natural Drug preparations) planned for filing the application for approval and which have been submitted as the data required for filing the application for approval to the competent authorities in the foreign countries,
or
- for the applications which are able to obtain and submit accurate and objective papers on the comparative controlled clinical trials which have been carried in the internationally accredited scientific journals and can be scientific substantiation.
Plants, plant parts utilized, methods of cultivation and processing, and the like need to be taken into consideration for reasoning that the preparations used in the above mentioned clinical trials and the Shoyaku-seizai (Natural Drug preparations) planned for filing the application are equivalent to each other in quality.
(2)
In consideration of the properties of Shoyaku-seizai (Natural Drug preparations), the current standard of science and technology, and other factors, part of the data required for applications may be omitted when the omission is judged to be scientifically appropriate. In such a case, the reasons for the omission shall be concretely described.
(3)
As for the data to be attached (the data on determination of structure and physical & chemical properties, etc.), the data on plants, the data on plant parts utilized (the identification method is to be included when identification of crude plant materials is scientifically possible), and the data on the methods of cultivation and processing shall be submitted. As occasion demands, the specifications & testing methods and the manufacturing method of the preparations applied for may be submitted to specify the foregoing. Furthermore, when an indicative ingredient is to be established in the specifications and testing methods, the data on the physical and chemical properties of the ingredient in question shall be also submitted.
3. Handling of Clinical Trial Protocol Notices
Persons who perform the clinical trials on the preparations corresponding to those specified in the above Item 1 shall submit beforehand the clinical trial protocol notices to the Minister of the MHLW in accordance with the Article 80-2, Paragraph 2 of the Pharmaceutical Affairs Law.
This Notification dated March 22 can be regarded as the fruition of assiduous efforts by JSMI so far, who has had its Strategic Alliance Conference for Business Promotion (SACBP) investigate ways to revitalize OTC medicines and instituted HERB PROJECT under the basic policy to establish a new area as one of the tasks high on the agenda.
3.The 31st Report on Consumer Awareness of Nonprescription Medicines
This report summarized the results of the consumer awareness survey conducted by means of a questionnaire in an advertorial concerning the OTC medicines carried in the Asahi Shimbun dailies on December 25, 2006. Following suit of the previous survey, JSMI conducted a survey on the consumer awareness of self-medication. The survey also covered how consumers use dietary supplements, how deeply consumers are interested in the revision of the pharmaceutical retailing system, and what is their preferable naming of the OTC medicines sold at drugstores and pharmacies.
BREAKDOWN OF THE RESPONDENTS
(A) Gender and Age
The respondents consisted of approximately 20% males (20.8 %) and 80% females (79.2 %).
1,000 respondents
Males 20.8 %
Females 79.2 %
1,000 respondents
Under 29 years old 6.8 %
The average age
30 ~ 39 years old 16.8 %
49.67 years old
40 ~ 49 years old 24.0 %
50 ~ 59 years old 28.5 %
60 ~ 69 years old 17.6 %
Above 70 years old 6.3 %
(B) Occupation
"Housewives" (37.1 %) showed the largest percentage of larger than 30 %, followed by "Salaried men/women" (35.1 %) of almost the same percentage, followed by "Jobless and Others" (20.5 %).
1,000 respondents
Salaried men/women
35.1 %
Free business/Self-employed
3.3 %
Students
1.1 %
Jobless and Others
20.5 %
Unanswered
2.9 %
BREAKDOWN OF THE RESPONDENTS
(1) Awareness of Self-Medication
The term, "Self-Medication", is defined as self-treatment of mild illnesses and injuries by the use of OTC medicines. Do you know this term ?
1,000 respondents
Yes, I know it pretty well
5.7 %
Yes, I know it to some extent
24.2 %
I have heard only the term
35.7 %
No. I don't know it
34.3 %
Unanswered
0.1 %
Awareness of the concept of "Self-Medication" was 29.9 % with "Yes, I know it pretty well" (5.7 %) and "Yes, I know it to some extent" (24.2 %) combined. Awareness of the term was 65.6 %, exceeding 60 % of the respondents, with adding "I have heard only the term" (35.7 %) to those two answers. Those who answered "No, I don't know it " indicated 34.3 %.
(2) Awareness of the revision of the retailing system of nonprescription medicines
From April 2007, the retailing system of OTC medicines will be revised. Do you know of this ?
1,000 respondents
Yes, I know of it.
16.1 %
No., I don't know of it.
26.6 %
Although I don't know of it, I am interested in it.
55.1 %
Neither I know of it nor I am interested in it.
2.1 %
Unanswered
0.1 %
"Yes, I know of it" (16.1 %) showed more than 10 percent. 83.8 % of the respondents, with "No, I don't know of it" (26.6 %), "Although I don't know of it, I am interested in it" (55.1 %), and "Neither I know of it nor I am interested in it" (2.1 %) combined, answered they do not know that the pharmaceutical retailing system will be revised.
(3) How to treat yourself when you do not feel well
When you do not feel well (for example, when you can diagnose yourself that you have caught a cold or you have stiff shoulders), how do you treat your discomforts ?
1,000 respondents
First of all, I will go to a drugstore/a pharmacy
18.2 %
to purchase a nonprescription medicine(s). First of all, I will go to a hospital to consult a physician
9.1 %
Depending on my condition, I will decide
50.6 %
whether I go to a drugstore/a pharmacy or a hospital. I will watch my condition for a while.
22.0 %
Unanswered
0.1 %
A total of 68.8 % respondents, with the largest 50.6 % of "Depending on my condition, I will decide whether I go to a drugstore/a pharmacy or a hospital," and "First of all, I will go to a drugstore/a pharmacy to purchase a nonprescription medicine(s)." (18.2 %) combined, expressed their intentions to use nonprescription medicines. Then, "I will watch my condition for a while." (22.0 %) and "First of all, I will go to a hospital to consult a physician." (9.1 %) followed.
(4) Awareness of dietary supplements
(4-1) Do you know of dietary supplements ?
1,000 respondents
Yes, I know of them
89.7 %
No, I don't know of them
8.9 %
Unanswered
1.4 %
Majority of the respondents answered "Yes, I know of them." (89.7 %)
(4-2) Have you ever tried dietary supplements ?
1,000 respondents
Yes, I have tried them.
68.5 %
No. I have never tried them.
26.6 %
Unanswered
4.9 %
Majority of the respondents answered "Yes, I have tried them." (68.5 %)
(5) Frequency to go to a drugstore/a pharmacy
How often do you go to a drugstore/a pharmacy ?
1,000 respondents
More than once a week
8.7 %
3 ~ 4 times a month
15.7 %
1 ~ 2 times a month
42.7 %
Less than once in 2 ~ 3 months
28.7 %
I don't go
3.3 %
Unanswered
0.9 %
The frequency of "1 ~ 2 times a month" (42.7 %) was the largest, followed by "Less than once in 2 ~ 3 months" (28.7 %), "3 ~ 4 times a month" (15.7 %) and "More than once a week" (8.7 %). Those who do not use drugstores/ pharmacies showed 3.3 %.
(6) The public image of a drugstore/a pharmacy
May we know your image of a drugstore/a pharmacy
960 respondents out of 1,000 answered.
Contents of Image
Respondent
%
Anything and everything are sold
231
24.1
Easy to consult pharmacists, Pharmacists are reliable
174
18.1
Convenient, Easy for shopping; Good, Satisfactory
88
9.2
Easy to give suggestions/requests to pharmacists
71
7.4
Less costly merchandise
64
6.7
Can buy anytime, Can buy without waiting, Easy to buy- Friendly atmosphere, Familiarity
51
5.3
Too large stocks of goods, Displays in disorder, Many items other than medicines
45
4.7
Many items other than medicines Bright, Clean, Spacious
37
3.9
Can utilize drugstores/pharmacies for treating discomforts not serious enough to necessitate to see a physician
37
3.9
Many store clerks such as part-timers who are not versed in professional knowledge, Hard to identify who is a pharmacist
34
3.5
Possibility of self-selection of medicines
30
3.1
960 respondents out of 1,000 answered on their image of drugstores/ pharmacies. 231 respondents, the largest in percentage (24.1 %) said drugstores/pharmacies have an image that "Anything and everything are sold". Also many respondents consider drugstores/pharmacies have now become "Supermarkets, convenience stores or home centers". These answers were followed by "Easy to consult pharmacists, Pharmacists are reliable" (174 respondents, 18.1 %), "Convenient, Easy for shopping, Good, Satisfactory" (100 respondents, 10.4 %) and "Easy to get in" (88 respondents, 9.2 %), majority of which represent quite favorable images such as "Drugstores/pharmacies are a convenient place carrying anything and everything", "They are easy to get in as they carry many items other than medicines" and "They are reliable and handy health centers".
