Medicinal Products, Pharmaceuticals

Proposed partial amendments to the "Regulation on Safety of Pharmaceuticals, etc."; (11 page(s), in Korean)

The proposed amendments to the "Regulation on Safety of Pharmaceuticals, etc." are as follows:

A. Specification of submission and follow up of Risk Management Plan (Article 4 and 8 of the draft)

To specify the data including legal sources that the person, who already obtained marketing authorization for the product provided with its Risk Management Plan, is required to summit when applying for another marketing authorization for new product or change.

B. Streamlined process of approval for change (Article 8)

To provide a legal basis for addressing changes in the medical product item together with approval for or notification of change, in case an application for approval for change in pharmaceutical manufacturing business (import) is submitted due to the change of manufacturer (importer) name or business site.

C. Specification of subject and items to be disclosed for data protection (newly established Article 21 bis)

To specify the pharmaceuticals subject to data protection to be determined by Ordinance of Prime Minister under the Pharmaceutical Affairs Act and the items to be disclosed including product name, manufacturer name and protection period

D. Specification of the subject for submission of a risk management plan (newly established Article 23 bis)

To specify the product to establish a Risk Management Plan to be determined by Ordinance of Prime Minister under the Pharmaceutical Affairs Act