GHTF Incidents - What does unlabeled and labeled mean?

jkc3usc

Starting to get Involved
#1
The GHTF states

· [FONT="Albertus (W1)"]Unlabeled serious incidents or near incidents – 15 days[/FONT]
· [FONT="Albertus (W1)"]Labeled serious incidents or near incidents – 30 days[/FONT]
· [FONT="Albertus (W1)"]Unlabeled medium level incidents or near incidence – 30 days[/FONT]
[FONT="Albertus (W1)"]Serious incidents by infectious diseases that could be caused by using medical devices – 15 days.[/FONT]
[FONT="Albertus (W1)"][/FONT]
[FONT="Albertus (W1)"]What does unlabeled and labeled mean? [/FONT]
[FONT="Albertus (W1)"][/FONT]
[FONT="Albertus (W1)"]Thanks [/FONT]
[FONT="Albertus (W1)"][/FONT]
[FONT="Albertus (W1)"][/FONT]
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#2
Which document are you talking about?

The "labeled" and "unlabeled" comes from the Japanese requirements, but I don't have the original Japanese document to verify right now.
 

jkc3usc

Starting to get Involved
#3
I mean what does labeled mean? Like is it on the label? If not its unlabeled?

or do it mean using it off label?

I got the requirements from GHTF (Global Harmonization Task Force)
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#4
I mean what does labeled mean? Like is it on the label? If not its unlabeled?

or do it mean using it off label?

I got the requirements from GHTF (Global Harmonization Task Force)
As I mentioned before, I don't have the original documents, so I can't say what it is. Anyway, the GHTF documents are old, and Japan had a recent revision of their regulations. So, the requirements mentioned in the GHTF document are probably superseded.

And I would suggest you always look into the original documents (in this case, the Japanese regulations, old or current) instead of a summary document such as the GHTF one, because these do tend to be invalid quickly due to changing regulatory requirements.
 

jkc3usc

Starting to get Involved
#5
Everything I have found still goes back to the issue of labeled or unlabeled. Looking at the current MDSAP as well.

Any other thoughts on what unlabeled and labeled means?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#6
Ok, just found the text of 228-20:

Article 228-20 (1) When a pharmaceutical marketing authorization holder or a designated foreign holder of special approval for pharmaceuticals finds matters about the marketed or approved pharmaceuticals in each of the following items, he/she shall report it to the Minister of Health, Labour and Welfare within the period specified in each of the following items:
(i) The following matters: 15 days.
(a) Death occurrence suspected to be caused by the side effects to the pharmaceuticals.
(b) Death occurrence suspected to be caused by the side effects to pharmaceuticals which are recognized to have the same components as said pharmaceuticals in a foreign country (hereinafter referred to "foreign pharmaceuticals") and cannot be predictable from package inserts, precautions for use indicated on a container or a capsule of the pharmaceuticals (hereinafter referred to as "precautions for use, etc."), or those that can be predicted from the precautions for use,etc. of the pharmaceuticals and fall under any of the following:
1. The trends including the number of death occurrences, the occurrence frequency occurrence conditions, (hereinafter referred to as the "occurrence trend"), which cannot be predicted from precautions for use, etc. of the pharmaceuticals.
2. The change of the death occurrence trend may show occurrences or expansion of any hazard or risk to the public health and hygiene.
(c) Among the following occurrences of cases, etc., cases suspected to be caused by some side effects of the pharmaceuticals or foreign pharmaceuticals that cannot or can be predicted from precautions for use, etc. for the pharmaceuticals or foreign pharmaceuticals, whose occurrence trend cannot be predicted or whose change of the occurrence trend may show the occurrence or expansion of any hazard or risk to the public health and hygiene (excluding matters listed in (d) and (e)).
1. Disability.
2. A case which may lead to death or disability.
3. A case which requires hospitalization in a hospital or clinic or extension of a hospitalization period for treatment (excluding a matter listed in 2.).
4. A case of death or a serious disease according to cases listed in 1. through 3.
5. A congenital disease or abnormality in later generations.
(d) In cases of pharmaceuticals with different active components from those approved pursuant to the provisions of paragraph 1 of Article 7 (i)(a)(1) of the Cabinet Order for Fees related to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (Cabinet Order No.91 of 2005), which are approved pursuant to the provision of paragraph 1 of Article 14 of the Law, those suspected to have been caused by side effects to the pharmaceuticals from among the occurrences of cases listed in (c)(1) through (5) related to those approved less than two years ago.
(e) Cases listed in (c)(1) through (5) of the preceding item suspected to be caused by the side effects to the pharmaceuticals (excluding matters listed in (d) of the preceding item).
(f) The occurrences of cases of infectious diseases suspected to be caused by the use of the pharmaceuticals and which cannot be expected from precautions for use, etc. of the pharmaceuticals.
(g) The death caused by infectious diseases or occurrences of cases listed in (c)(1) through (5) and which are suspected to be caused by the use of the pharmaceuticals or foreign pharmaceuticals (excluding those listed in (f)).
(h) Implementation of measures to prevent occurrence or expansion of the suspension of manufacturing, import, or sales of foreign pharmaceuticals, collection, abolishment of the pharmaceuticals, and other hazards or risks to public health and hygiene.
(ii) The following matters: 30 days.
(a) Occurrences of cases listed in (c)(1) through (5) of the preceding item which are suspected to be caused by the side effects of the pharmaceuticals (excluding matters listed in (c), (d), and (e) of the preceding item).
(b) Report studying risks of cancers, other serious diseases, disabilities, or death caused by side effects of the pharmaceuticals or foreign pharmaceuticals or infectious diseases produced by their use, cases caused by side effects of the pharmaceuticals or foreign pharmaceuticals, or significant change of the occurrence trend of infectious diseases caused by their use, or approved efficacies or non-effects of the pharmaceuticals.
(iii) Occurrences of cases suspected to be caused by the following side effects to pharmaceuticals (excluding death or cases listed in item (i)(c)(1) through (5)) that cannot be predicted from precautions for use, etc. of the pharmaceuticals: by the following terms depending on the following classifications of pharmaceuticals.
(a) New pharmaceuticals prescribed by paragraph 1 of Article 14.4 (i) of the Law and pharmaceuticals designated by the Minister of Health, Labour and Welfare pursuant to the provision of paragraph 1 of Article 14.4 (ii) of the Law: the periods prescribed by paragraph 3 of Article 63.
(b) Pharmaceuticals other than those listed in (a): Within two (2) months after the expiration of the period every year for each additional year from the date when the medical device obtained a marketing approval, etc.
(2) When a marketing authorization holder of medical devices or a designated foreign holder of special approval for medical devices finds any matter concerning marketed or approved medical devices listed in each of the following items, he/she shall report the finding to the Minister of Health, Labour and Welfare within the period respectively specified by each of the items.
(i) The following matters: 15 days.
(a) Death occurrences suspected to be influenced by any failure of the medical device.
(b) Death occurrences suspected to be influenced by any failure of a medical device used in a foreign country which bears similarities in shape, structure, raw material, usage, efficacy, effect, performance, etc., as the medical device in a foreign country (hereinafter referred to as the "foreign medical device") and it is impossible to predict the occurrence from precautions, etc. on use of the medical devices, etc.
(c) From among occurrences of cases listed in item (i) (c)(1) through (5) of the preceding paragraph, the occurrences suspected to be influenced by any failure of the medical device or foreign medical device which may not be predicted from precautions for use, etc. on the medical devices, etc.
(d) From among the changes of the rate of occurrence of failure related to medical devices separately stipulated by the Minister of Health, Labour and Welfare to understand the rate of occurrence of failures (limited to those related to occurrences or risks of death or cases, etc. listed in paragraph 1(c)(1) through (5); the same shall apply in (d) and (f)below) in advance, higher than the rate of occurrence of failures related to the medical devices a marketing authorization holder or a designated foreign holder of special approval for medical devices understand in advance (excluding the matters listed in (a)).
(e) From among occurrences of cases, etc., listed in paragraph 1(c)(1) through (5) of the preceding paragraph, the occurrences suspected to be influenced by any failure of the medical device which may be predicted from precautions for use on the medical devices, etc., and fall under any of the following (excluding matters listed in (d)).
1. The occurrence trend cannot be predicted from precautions for use, etc. of the medical devices.
2. A change in occurrence trend shows a risk of occurrence or expansion of hazard or risk to public health and hygiene.
(f) In cases where the foreign medical device failure occurrence rate can be obtained in advance, a change of the foreign medical device failure occurrence rate, which is larger than the failure rate of the medical device obtained by a marketing authorization holder or a designated foreign holder of special approval for medical devices in advance.
(g) Occurrences of cases of infectious diseases suspected to be caused by the use of the medical device and which cannot be predicted from precautions for use on the medical device.
(h) Occurrences of death or diseases listed in item (i)(c)(1) through (5) of the preceding paragraph excluding matters listed in (g)) suspected to be caused by the use of the medical device or foreign medical device.
(i) Implementation of measures to prevent the occurrence or increase of the suspension of manufacturing, import, or sales of the medical devices or foreign medical devices, the collection, abandonment, or other hazard or risk to the public health and hygiene.
(ii) The following matters: 30 days.
(a) The occurrences of death and diseases, etc., listed in item (i)(c)(1) through (5) suspected to be influenced by failures of the medical device or foreign medical device (excluding cases where matters listed in (a) through (e) of the preceding item and (a) of the next item and the foreign medical device failure occurrence rate prescribed by (f) of the preceding item can be obtained in advance).
(b) The occurrences of failures of the medical device or foreign medical devices which may cause death or diseases, etc., listed in item (i)(c)(1) through (5) of the preceding paragraph excluding cases where matters listed in (d) of the preceding item and (a) of the following item and the occurrence rate of the foreign medical device failure prescribed by the preceding item (f) can be obtained in advance).
(c) Report studying risks of cancers, other serious diseases, disabilities, or death caused by infectious diseases caused by failures or the use of the medical devices or foreign medical devices, cases caused by failures of the medical devices or the foreign medical devices, or significant change of the occurrence trend of infectious diseases caused by their use, or these devices have neither approved efficacy nor effect.
(iii) The following matters: Every additional year since the date when the medical device obtained a marketing approval and within two months after the expiration of the period.
(a) The medical device failure prescribed by item (i)(d), which may lead to the occurrence of death or diseases, etc., listed in item (i)(c)(1) through (5) or the predicted risk/danger of the occurrences of these failures, etc. (excluding matters listed in item (i)(a) through (d)).
(b) The occurrences of death and diseases other than those listed in item (i)(c)(1) through (5) suspected to be influenced by the medical device failures that cannot be predicted from precautions on the use of medical devices.
(c) The occurrences of failures of the medical device which may lead to death and diseases other than those listed in paragraph 1(i)(c)(1) through (5) that cannot be predicted from precautions for use, etc. on the medical device.
(3) The provision in the preceding paragraph shall apply mutatis mutandis to a report on failures on a part related to apparatus and instruments of the pharmaceuticals by a marketing authorization holder or a designated foreign holder of special approval for pharmaceuticals who obtained an approval of pharmaceuticals marketed integrally with apparatus and instruments.
(4) When a marketing authorization holder of regenerative medicine products or a designated foreign holder of special approval for regenerative medicine products finds matters concerning marketed or approved regenerative medicine products listed in each of the following items, he/she shall report the finding to the Minister of Health, Labour and Welfare within the period respectively specified by each of the items.
(i) The following matters: 15 days.
(a) Death occurrences suspected to be influenced by any failure of the regenerative medicine products.
(b) Death occurrences suspected to be influenced by any failure of the regenerative medicine products used in a foreign country which bear similarities in component cell, structure, manufacturing methods, usage, etc., with the regenerative medicine products (hereinafter referred to as the "foreign regenerative medicine products") and it is impossible to predict the occurrence from cautions on use of the regenerative medicine products, etc.
(c) Occurrences of cases, etc., listed in paragraph 1(i)(c)(1) through (5) suspected to be influenced by failures of the regenerative medicine products or foreign regenerative medicine products that cannot be predicted from cautions on the use of regenerative medicine products.
(d) From among occurrences of cases, etc., listed in paragraph 1(c)(1) through (5) of the preceding paragraph, the occurrences suspected to be influenced by any failure of the regenerative medicine products which may be predicted from precautions for use, etc. on the regenerative medicine products, etc., and fall under any of the following.
1. The occurrence trend cannot be predicted from precautions on the use of regenerative medicine products.
2. change in occurrence trend shows a risk of occurrence or expansion of hazard or risk to public health and hygiene.
(e) The occurrences of cases of infectious diseases suspected to be caused by the use of the regenerative medicine products and which cannot be expected from precautions for use, etc. of the regenerative medicine products.
(f) Occurrences of death or diseases listed in item (i)(c)(1) through (5) of the preceding paragraph excluding matters listed in (e)) suspected to be caused by the use of the regenerative medicine products or foreign regenerative medicine products.
(g) Implementation of measures to prevent the occurrence or increase of the suspension of manufacturing, import, or sales of the foreign regenerative medicine products, the collection, abandonment, or other hazard or risk to public health and hygiene.
(ii) The following matters: 30 days.
(a) The occurrences of death and diseases, etc., listed in paragraph 1(c)(1) through (5) suspected to be influenced by failures of the regenerative medicine products or foreign regenerative medicine products (excluding cases of matters listed in (a) through (e) of the preceding item).
(b) The occurrences of failures of the regenerative medicine products or foreign regenerative medicine products, which may lead to a risk of death or diseases, etc. listed in paragraph 1(c)(1) through (5).
(c) Report studying shows risks of cancers, other serious diseases, disabilities, or death may be caused by infectious diseases resulting from failures or the use of the regenerative medicine products or foreign regenerative medicine products, or cases, etc. resulting from failures of the regenerative medicine products or foreign regenerative medicine products or significant change of the occurrence trend of infectious diseases resulting from their use, or the regenerative medicine products have neither approved efficacy nor effect.
(iii) The following matters: for each additional year since the date when the regenerative medicine products obtained a marketing approval and within two months after the expiration of the period.
(a) Occurrences of death and diseases, etc., other than those listed in paragraph 1 (i)(c)(1) through (5) suspected to be influenced by failures of the regenerative medicine products that cannot be predicted from precautions for use on the regenerative medicine products.
(b) The occurrences of failures of the regenerative medicine products which may lead to death and diseases other than those listed in paragraph 1 (i)(c)(1) through (5) that cannot be predicted from precautions for use, etc. on the regenerative medicine products.
(5) When a marketing authorization holder of quasi-drugs or cosmetics or a designated foreign holder of special approval for pharmaceuticals finds matters in each of the following items, he/she shall report it the same to the Minister of Health, Labour and Welfare within a period specified by each of the following items.
(i) The following matters: fifteen (15) days.
(a) Death which may occur due to the side effects of the quasi-drugs or cosmetics.
(b) Among the following occurrences of cases, etc., cases, which may be caused by some side effects of quasi-drugs or cosmetics, cannot or can be predicted from precautions for use for the quasi-drugs or cosmetic, etc., whose occurrence trend cannot be predicted from the occurrence trend or whose change of the occurrence trend may trigger or expand any hazard or risk to the public health and hygiene.
1. Disorder.
2. A case which may lead to death or disorder.
3. A case which requires hospitalization in a hospital or clinic or extension of a hospitalization period for treatment (excluding a matter listed in (2).
4. A case of death or a serious disease according to cases listed in (1) through (3).
5. A case where a predictinged period required for treatment is 30 days or more (excluding cases listed in (2), (3), and (4)).
6. A congenital disease or abnormality in later generations.
(ii) The following matters: thirty (30) days.
(a) Cases listed in (b)(1) through (6) of the preceding item which may occur due to the side effects of the quasi-drugs or cosmetics (excluding matters listed in (b) of the preceding item).
(b) Study reporting showing the risk of causing harmful effects in the quasi-drugs and cosmetics.
So, the "labeled"or "unlabeled" means if the occurrence which may or may not not be predicted from precautions for use (label).
 

jkc3usc

Starting to get Involved
#7
Thanks!

So with this information I am trying to put a medical device decision tree together for adverse reporting decisions. Have you ever come across one for Japan?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#8
Nope, I don't remember seeing any in particular, although I do have worked with Japanese manufacturers in the past (but not on PMS).
 

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