Overview
Overview of Pharmaceutical Approval Process
- Approve pharmaceuticals whose safety, efficacy, and quality are identified (including pharmaceutical ingredients) through technological review and inspection for their manufacturing and distribution.(「Pharmaceutical Affairs Act」Article 31)
- Classification of pharmaceuticals : Drug products, pharmaceutical ingredients
- Classification of drug products : New Drug, Pharmaceutical required for data submission and Generic Drug
- New Drug refers to a new material pharmaceutical whose chemical structure or original composition is totally different from a pharmaceutical previously approved in Korea or a multiple preparation containing a new material as an active drug substance, which is designated by Minister of Food and Drug Safety. (「Pharmaceutical Affairs Act」Article 2 Subparagraph 8)
- Pharmaceutical required for data submission refers to not a new drug but a pharmaceutical required for the safety and efficacy evaluation. (Regulation on Pharmaceuticals Approval, Notification and Review (MFDS Notification) Article 2 Subparagraph 8) e.g.) pharmaceuticals with new effectiveness, new composition or increase/decrease of strength of active drug substance, and pharmaceuticals with new route of administration etc.
- Generic Drug refers to a pharmaceutical which is equivalent to a new drug (reference drug) in terms of active ingredient, dosage form and strength
Data Requirements for Approval
- New Drug (「Regulation on Safety of Pharmaceuticals」(Ordinance of the Prime Ministerial) Article 9)
- (Review by Drug Evaluation Department) Safety & efficacy data, specifications & test methods, Drug Master Files (DMF), certificate of manufacturing and marketing(Imported Pharmaceutical) Data such as name and address of manufacturers of active pharmaceutical ingredients
- (Review by Other Departments) Evaluation data of conducting of Good Manufacturing Practice (GMP)
Figure 1. Dossier for Safety & Efficacy Evaluation
Data on Drug Substance
- Data on structure identification
- Data on physical & chemical properties
- Data on manufacturing methods
- Data on specifications & test methods are stated
- Supportive data on specifications & test methods
- Data on test results
- Data on reference standards, reagents, and test solutions
- Data on containers & packaging materials
Data on drug product
- Data on drug product
- Data on composition
- Data on manufacturing methods
- Data on specifications & test methods are stated
- Supportive data on specifications & test methods
- Data on test results
- Data on reference standards, reagents, and test solutions
- Data on containers & packaging materials
- Pharmaceutical required for data submission : Selectively submit data required for safety and efficacy evaluation among submission data for new drug.
- Generic Drug : Submit bioequivalence test data and quality data instead of safety and efficacy data such as toxicity, pharmacology, clinical trials. 「Regulation on Safety of Pharmaceuticals」(Ordinance of the Prime Ministerial) Article 4 (1) 3
- Generic drugs are reviewed by Drug Evaluation Department and approved by regional FDAs.
Work Flow for Approval of Pharmaceuticals
- New drug, Pharmaceutical required for data submission
- In the whole process of drug review and approval, consult with Central Pharmaceutical Affairs Advisory Committee (CPAC), if necessary
- Product Manager (PM) a general manager from submission, pre-review, supplementation, approval and revision for each product
- Pre-review system : PM examines submission data and the adequacy of data requirements
- Product Briefing
- (Priority) new drug, IMD and when requested by civil petitioner
- (Participants) civil petitioner, Review Division, Pharmaceutical Policy Division
Improve efficiency and predictability of review and approval process by enhancing mutual understanding between reviewer and petitioner of a product required for approval process - Drug Approval Update
Weekly withdrawals, monthly approvals, approval report (NDA), evaluation results of safety and efficacy (pharmaceuticals required for data submission)
- Generic Drug
- Required Application Documents : Bioequivalence study, GMP documents and CMC(Chemistry, Manufacturing, Controls) data
Figure 1. the Process of Generic Drugs Approval
- RFDA approve generic drugs via drug approval evaluation
- In the whole process of drug review and approval, consult with Central Pharmaceutical Affairs Advisory Committee (CPAC), if necessary.
