An entity that conforms with any of the following descriptions may accept a contract for analysis of drug (medicinal) products:
1. A medicinal product factory that is in compliance with the Regulations Governing Good Manufacturing Practices for Medicinal Products.
2. A domestic or foreign academic research institute that meets the requirements of good laboratory practices for non-clinical laboratory studies.
3. An analysis institution or laboratory that meets the certification requirements under Article 104-4 of the Act.
4. Other entity approved on an ad-hoc basis by the competent central health authority.

The contract party and the contract inspector shall enter into a contract analysis agreement, which shall include matters related to the scope of contract analysis, an operation plan, and the standard operating procedures.

The contract party shall firstly find a party, willing to undertake the contract analysis, then fill in an application form and attach the contract analysis agreement ,related documentation and apply to the central competent health authority for the approval.
The central competent health authority may carry out an on-site analysis of the contract inspector as it deems necessary in accordance with the actual conditions.

When the approval has been obtained for contract analysis, the number of subject items to be inspected that the contract party submits to the contract inspector shall be two or more times the number needed for analysis; any subject items remaining after analysis with their packaging intact shall be sealed and returned to the contract party by the contractor.