pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
Rules, regulations and guidelines associated with the innovative drug development and approval in the United States, the European Union, and the Republic of Korea
| Region | Category | Titles and Sections |
|---|---|---|
| United States (FDA) | Rules and regulations | Code of Federal Regulation Title 21 |
| Part 312. Subpart E. Drugs intended to treat life-threatening and severely-debilitating illnesses | ||
| Part 314. Subpart H. Accelerated approval of new drugs for serious or life-threatening illnesses | ||
| Part 601. Subpart E. Accelerated approval of biological products for serious or life-threatening illnesses | ||
| Federal Food Drug and Cosmetic Act. Section 506(a) | ||
| Added by FDA Safety Innovation Act. Section 902. Breakthrough therapies. | ||
| Federal Food Drug and Cosmetic Act. Section 506(b) | ||
| Added by FDA Modernization Act. Section 112. Expediting study and approval of fast track drugs | ||
| Federal Food Drug and Cosmetic Act. Section 506(c) | ||
| Added by FDA Safety Innovation Act. Section 901. Enhancement of accelerated patient access to new medical treatments | ||
| Prescription User Fee Act | ||
| Guidances for industry | Expedited Programs for Serious Conditions – Drugs and Biologics | |
| Expedited Programs for Regenerative Medicine Therapies for Serious Conditions | ||
| European Union (EMA) | Rules and regulations | Directive No 2001/83/EC. Annex I |
| Regulation (EC) No 141/2000, No 726/2004. Article 14(8), No 726/2004. Article 14(9) | ||
| Commission Regulation (EC) No 507/2006. Article 11 | ||
| Decision No 1082/2013/EU | ||
| Guidelines | Guideline on procedures for the granting of a marketing authorization under exceptional circumstances, pursuant to article 14(8) of regulation (EC) No 726/2004 | |
| Guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004 | ||
| Guideline on the scientific application and the practical arrangements necessary to implement Commission Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 | ||
| European Medicines Agency Guidance for applicants seeking access to PRIME scheme | ||
| Republic of Korea (MFDS) | Rules and regulations | Pharmaceutical Affairs Act (Amendment 2024) |
| Article 35 (Conditional Permission) | ||
| Article 35-4 (Designation of Drugs Subject to Accelerated Examination) | ||
| Regulation on Safety of Pharmaceuticals, etc. (Amendment 2024) | ||
| Article 39-2 (Application for Conditional Approval of Items, etc.) | ||
| Article 40-2 (Designation of Priority Review) | ||
| Regulation on Pharmaceutical Approvals, Notifications and Reviews (Amendment 2023) | ||
| Article 58 (Expedited Review Etc) | ||
| Regulation on Review and Authorization of Biological Products (Amendment 2021) | ||
| Article 41 (Fast Tract Review Process) | ||
| Guidelines | Guideline on the application criteria for the fast track review of pharmaceuticals (2021) | |
| Complainant Guide | ||
| Instructions for the Conditional Permission of Drug Products | ||
| Considerations on the Request of a Fast Track Review Designation of Medicinal Products | ||
| Casebook of the Expedite Review in Major Foreign Countries | ||
EMA, European Medicines Agency; FDA, Food and Drug Administration; MFDS, Ministry of Food and Drug Safety