Drug Registration (With PRS 2.0 information)

Application for Registration of Pharmaceutical Products

• Guidance Notes on Registration of Pharmaceutical Products/Substances
• Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity
• Guidance Notes on Registration of Biosimilar Products
• Guidance on Application of Certificate of Drug/ Product Registration – Advanced Therapy Products
• Guidance Notes on Registration of Medical Gases

Change of Registered Particulars of a Registered Pharmaceutical Product

• Guidance Notes on Change of Registered Particulars of Registered Pharmaceutical Products/Substances

Renewal of Pharmaceutical Product Registration

• Notification for Renewal of Registration Certificate

Classification of Products

• Guidance Notes on Classification of Products as "Pharmaceutical Products" under the Pharmacy and Poisons Ordinance (Cap. 138)

Supplementary Information for Drug Registration

• Guidelines on the Labelling of Pharmaceutical Products
• Guidelines on the Labelling of Pharmaceutical Products
• Guidance on Labelling Requirements of Product Code, Unique Donation Identifier and Unique Recipient Identifier for Advanced Therapy Products
• Letters Issued by Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances) Committee on Labelling of Pharmaceutical Products (Indexed by Date)
• Letters Issued by Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances) Committee on Labelling of Pharmaceutical Products from year 2015 (Indexed by Ingredient)
• Frequently Asked Questions and Answers on Phase 2 Requirement of Bioavailability and Bioequivalence Studies
• Questions and Answers on PIC/S GMP Requirements for Registration of Imported Pharmaceutical Products
• General Requirements for Master Formula and Specifications for Non-Biological Products
• Requirement of Elemental Impurities Levels/Limits in Registered Pharmaceutical Products
• Requirement of Microbiological Quality of Registered Pharmaceutical Products in Non-sterile Dosage Forms
• Supplementary Notes for Application for Registration of Biological Products Involving Alternative / Back Up Manufacturer(s) for Manufacturing Steps (English version only)

Pharmaceuticals Registration System (PRS 2.0)