Regulatory Status for Use in Drugs

Chondroitin Sulfate Sodium
Japan

This section provides a regulatory assessment for the use of Chondroitin Sulfate Sodium in Drugs in Japan.

3.1 Authorized Usage in Drugs

Regulatory background on drugs legislation

In Japan, drugs are divided into “drugs” and “quasi-drugs”. “Drugs” are further divided into “prescription drugs” and “over-the-counter (“OTC”) drugs” under the Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960) [1] (“Pharmaceuticals and Medical Devices Act”) (See Appendix). Under this Act, all drug products are subject to pre-market authorization by the MHLW on a final product basis. The permissibility of ingredients used in those drug products is determined during such authorization process by the final product. 

Chondroitin Sulfate Sodium

Chondroitin sulfate sodium has been used as an active agent in prescription drugs, and OTC drugs intended for joint and nerve pain, for protection of the cornea of the eyes, or for nutrition supplements [2]. It has also been used in quasi-drug products such as skin lotion and cream, and scalp care [3]. Therefore, the manufacturer’s Chondroitin sulfate sodium could be allowed for use if a final drug or quasi-drug product containing the manufacturer’s ingredient is authorized by the MHLW. 

3.2 Applicable Specifications (including mandatory quality requirements, if any) 

As a drug and quasi-drug

For chondroitin sulfate sodium as a quasi-drug, the MHLW established a specification (See section 3.5 - ANNEX - below), and it is included in the Japanese Standards of Quasi-drug Ingredients (“JSQI”) 2021 [4] which is currently available only in Japanese. 

Table 1 compares the main parameters of the JSQI with the specification of the product under consideration. This comparison can not be 100% accurate due to the difference in the analytical method used, and while it is indicated that the product’s manufacturing method (microbial fermentation) does not conform to the JSQI’s definition (extraction from animal soft bone), this does not mean that the product is not allowed for use in quasi-drug products. As described in Section 3.1, the permissibility of ingredients used in those drug products is evaluated and determined by the final product. Therefore, the product under consideration would be allowed for use if a final quasi-drug containing it is authorized by the MHLW. This is the same for drugs.

3.3 Registration Requirements

As a drug and quasi-drug

As described in the previous section, the current Japanese regulatory system is not designed to grant authorization for drug ingredients. Therefore, no registration is required for drug ingredients while their permissibility is evaluated and determined on a final product basis. However, the Pharmaceuticals and Medical Devices Act [6] requires conformity with the Good Manufacturing Practice (GMP) for drug ingredients that will be marketed in Japan (Article 14 (2)) and acquisition of Accreditation of Foreign Manufacturer from the MHLW for drug manufacturers located outside of Japan (Article 13-3). Specific requirements of the GMP are provided by the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs (Ordinance of Ministry of Health, Labour and Welfare No.79 of 2004) [7]. Further details of the Accreditation of Foreign Manufacturers system can be found on the webpage of the Pharmaceuticals and Medical Devices Agency (“PMDA”) in English [8]. 

3.4 References

3.5 Annex

Sodium chondroitin sulfate specifications from the Japanese Standards of Quasi-drug Ingredients (“JSQI”) 2021 [4]