These Regulations are adopted pursuant to Article 42, paragraph 2 of the Pharmaceutical Affairs Act ("the Act").

Contract manufacturing and analysis of drug (medicinal) products shall be conducted in accordance with these Regulations; matters for which these Regulations make no provision shall be governed by other relevant laws and regulations.

"Contract manufacturing," as used in these Regulations, means the contract of another firm to perform manufacturing during any stage, successive stages, or the entire process of the manufacturing of a drug.

"Contract analysis," as used in these Regulations, means the contract of another firm or a relevant agency to carry out research and development in the technical aspects of medicinal products, control of production, quality control and stability testing for active pharmaceutical ingredients, semi-finished products, and end products.

An application shall be submitted to and approved by the central competent health authority prior to any contracted manufacturing or analysis of medicinal products.
Only a pharmaceutical firm that currently holds a drug license or has applied for registration and market approval for a given medicinal product may make an application for contract manufacturing and analysis of medicinal products.

Except where otherwise provided by law or regulation, when a medicinal product has been approved for contract manufacturing or analysis, related product liability is borne by the contract party.

When the effective term of a contract for manufacturing or analysis expires and the contract is not renewed, or the contract is rescinded for any reason during its effective term, or the items to be manufactured or inspected are changed, the contract party shall first find another contract manufacturer or relevant agency and newly apply for contract manufacturing or analysis in accordance with regulations.