"1+" mechanism for Registration of Pharmaceutical Products
containing New Chemical or Biological Entities
Letters to Trade
Extending the "1+" Mechanism for Applications for Registration of Pharmaceutical Products containing New Chemical or Biological Entities (issued on 25.10.2024)
Incentive Measures for Applications for Registration of Pharmaceutical Products under "1+" Mechanism (issued on 27.06.2024)
Enhancement of Evaluation Procedures for Applications for Registration of Pharmaceutical Products under "1+" Mechanism (issued on 25.03.2024)
Update of Registration Requirements for Pharmaceutical Products containing New Chemical or Biological Entities (issued on 26.10.2023)
Guidance for Industry
Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity (updated on 01.11.2024)
Guidance on Application of Certificate of Drug/Product Registration - Advanced Therapy Products (updated on 01.11.2024)
Local Expert Assessment Report Template (updated on 01.11.2024)
Frequently Asked Questions
List of Pharmaceutical Products Registered Under "1+" Mechanism (as of 8 November 2024)