Medicinal Products
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Medicinal Products Regulatory Support in Hong Kong – Overview

Hong Kong serves as a strategic gateway to Mainland China and Southeast Asia, with a robust Regulatory system ensuring the safety, efficacy, and quality of medicinal products. The Drug Office (Department of Health) and the Pharmacy and Poisons Board (PPB) oversee product registration, import/export control, and pharmacovigilance. To secure registration, companies must submit a complete dossier, appoint a local representative, and comply with PIC/S GMP and labeling norms. Freyr streamlines this process, ensuring Regulatory accuracy, compliance, and faster approvals.

Medicinal Product Classification in Hong Kong

In Hong Kong, medicinal products are regulated under the Pharmacy and Poisons Ordinance (Cap. 138), which covers substances used to treat, prevent, or diagnose diseases, as well as advanced therapy products like gene, cell, and tissue-engineered therapies.

Drugs are classified based on composition, potency, toxicity, and intended use into three main categories:

• Over the Counter (OTC) Medicines – Contain no poisons or only Part 2 Poisons; sold in retail shops for non-poisons) or sold in pharmacies or licensed medicine stores for Part 2 Poisons.
• Pharmacy-Only Medicines – Contain Part 1 Poisons; can be sold only in pharmacies under a registered pharmacist’s supervision.
• Prescription Only Medicines – Contain Part 1, Third Schedule Poisons. Sale permitted only with a valid prescription.

Additional regulations apply to antibiotics (Cap. 137) and dangerous drugs (Cap. 134), both treated as prescription-only. All pharmaceutical products must be registered with the Pharmacy and Poisons Board, and sale or possession of unregistered products is prohibited.

Medicinal Product Drug Registration & Approval

Drug registration in Hong Kong is regulated by the Drug Office (Department of Health) under the Pharmacy and Poisons Board (PPB). The key steps include:

• Application Submission
   Submit via PRS 2.0 in CTD format (Modules 1–5) with required documents like GMP, CPP, and labeling.
• Screening
   Drug Office verifies completeness and accuracy; missing data may delay review.
• Evaluation
   Quality, safety, and efficacy are assessed, referencing approvals from ≥2 countries (or 1 under the “1+ mechanism”).
• Registration Approval
   Upon approval, a Registration Certificate (valid for 5 years) is issued via PRS 2.0.
• Import Licensing
   Registered products need an Import License approved by the Drug Office and Trade & Industry Department.
• Manufacturing & Wholesale Licensing
   Local manufacturers need a Manufacturer License with PIC/S GMP; distributors need a Wholesale Dealer License.
• Labeling & Packaging Compliance
   Labels must be bilingual (English & Chinese) and include dosage, route, frequency, and indications.
• Pharmacovigilance
   Maintain a system to monitor and report ADRs to the Drug Office.
• Variation Applications
   Submit and obtain approval for any formulation, packaging, or site changes before implementation.
• Renewal & Post-Market Surveillance
   Registration is renewable every five years with ongoing safety monitoring.

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Specifics for Key Product Types 

• Generics: Require evidence of pharmaceutical equivalence and bioequivalence or justification based on BCS classification.
• Biologics and Biosimilars: Must include comparability studies and may require testing or additional documentation per PPB guidance.
• Vaccines: Require GMP verification, batch release documentation, and detailed cold-chain stability data.
• OTC Medicines: Simplified dossier requirements but must comply with local labeling, safety, and advertising standards.

Post-Approval & Pharmacovigilance 

Once registered, the product is subject to continuous post-market surveillance:

• Renewal: Every 5 years, with updated safety and manufacturing information.
• Variations: Must be submitted for approval prior to implementation.
• Pharmacovigilance: Holders must report adverse drug reactions (ADRs) and maintain a local safety monitoring system.
• Market Surveillance: The Drug Office conducts regular sampling, investigates adverse drug reactions, and compliance checks.

Freyr supports end-to-end post-approval lifecycle management for Hong Kong registrations.