Japan Revise Standards of Quasi Drug Ingredients 2006

Japan has published the revision to the Standards of Quasi Drug Ingredients 2006. The revision includes amendments to 14 testing methods, 9 existing ingredients standards and the addition of 7 new ingredient standards. This revision has been effective since Mar 29, 2018. Stakeholders have been given a grace period of over 1 years which will end on Sep 30th, 2019. Within this period previous compliance requirements will apply. The revised 14 testing methods are as follow...

Takehome:

This revision has been effective since Mar 29, 2018. Stakeholders have been given a grace period of over 1 years which will end on Sep 30th, 2019. Within this period previous compliance requirements will apply.

The revised 14 testing methods are as follow:

No.	Testing methods
1	Liquefied gas testing method;
2	Ignition Loss Test;
3	Determination of acid value;
4	Oxygen flask combustion method;
5	Heavy metal testing method;
6	Potentiometric titration;
7	Glycolipid/polysorbate testing method;
8	Ebulliometry and distillation testing method;
9	Polyoxyalkylene alkyl ether Test Method;
10	Lipase titer test method;
11	Standards (Part of testing methods have added new standards in standards items)
12	Reagents (Part of testing methods have modified or added new reagent in reagent items)
13	Volumetric analysis standard liquid (Part of testing methods have modified or added new volumetric analysis standard liquid)
14	Standard liquid (One testing method has modified the items of standard liquid)

The standards of the following 7 ingredients are added:

No.	Ingredient name
1	Hydrolyzed Royal Jelly Protein Solution;
2	Bis (Ethoxydiglycol) Cyclohexane-1, 4-Dicarboxylate;
3	Stearoyl Inulin;
4	Dextrin Palmitate / Ethylhexanoate;
5	Placental Extract (4);
6	Placental Extract (5);
7	Lauroylamidopropyl Dimethylamine Oxide Solution;

Note: Before Sep 30 2019, stakeholders applying for marketing licenses shall only write down "Standards of Quasi Drug Ingredients" in the "concentration" column of the application form. Applicants having obtained the license shall submit application for modification and change the content of the "concentration" column into "Standards of Quasi Drug Ingredients".

The standards of the following 9 existing ingredients are revised:

No.	Ingredient name
1	Alkyl (8-16) Glucoside;
2	Dithiodiglycolic Acid;
3	Diammonium Dithiodiglycolate Solution;
4	Placental Extract (1);
5	Placental Extract (2);
6	Placental Extract (3);
7	Poly N, N-Dimethyl-3, 4-Dimethylene-Pyrrolidinium Chloride Solution;
8	Magnesium Aluminometasilicate;
9	Oil-soluble Placental Extract;

Note: Before Sep 30 2019, stakeholders applying for marketing licenses shall write down "Amendments of Standards of Quasi Drug Ingredients" in the "concentration" column on application form.