HONG KONG DRUG LICENSING

Hong Kong Drug Licence FAQs

Search 500 Hong Kong drug licence FAQs on applications, personnel, premises, quality systems, ongoing regulation, renewals and acquisitions.

Information status: The original FAQ material dates from 2025 and is provided for topic-based reference; it does not represent an individual verification of all 500 FAQs against current rules. For application, fee, renewal, change, product or prescription requirements, please refer to the current official forms and guidance.

Official information from the Drug Office Official information from the Chinese Medicines Board

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Q341 · 在药品批发公司中，质量部门（Quality Unit/Department）的具体角色和职责是什么？独立链接

The quality department is the “guardian” responsible for protecting medicine quality, independent of commercial operations such as sales and procurement. Its core responsibility is to ensure that all company activities strictly comply with GDP requirements and the internal Quality Management System. Specifically, the quality department’s responsibilities span the entire operation: it establishes and maintains QMS documentation (such as SOPs); leads or participates in all key quality-related activities, including deviation investigations, change control, CAPA management and internal and external audits; conducts supplier and customer qualification checks; provides GDP training to staff; reviews and approves all quality-related records; makes final decisions on returns, complaints and recalls; and releases finished products to the market. To fulfil these responsibilities, the quality department must be given sufficient authority and resources, and its decisions must not be influenced by commercial interests.

📘 Regulatory basis

GDP principles emphasise the need for an independent quality system, with its implementation overseen by authorised personnel (usually within the quality department). The RP is generally the head of the quality department and has ultimate responsibility for the effectiveness of the quality system.

📗 Drew Tang's recommendations

We recommend that clients, including small companies, clearly appoint at least one full-time or part-time quality lead and give them clear responsibilities and independence. The quality department should not be seen as the “brakes” on the business, but as its “navigator”. By becoming involved early in the design of new business activities and processes, the quality department can help the company establish a compliant and efficient operating model from the outset.

📕 Risk notice

A quality department with no real authority or no presence at all is one of the most serious organisational deficiencies in the regulator’s eyes. If quality decisions are driven entirely by sales or profit, the entire QMS is a mere formality. If an investigation into a quality incident finds that the department’s independence was compromised, the company and its management will face extremely serious consequences.

Q342 · 当发现运输途中的冷链药品出现了温度偏差（Temperature Excursion），我该如何处理？独立链接

A temperature excursion is an urgent and serious matter that requires an investigation to be initiated immediately. Step 1: Immediately segregate the affected medicines in an “under investigation” area, clearly label them and prohibit their entry into saleable stock. Step 2: Record the excursion details, including the temperature outside the permitted range, its duration and all relevant details of the transport process. Step 3: Contact the medicine manufacturer immediately and provide complete temperature excursion data. Only the manufacturer has the medicine’s stability data and can authoritatively determine whether the excursion has had an unacceptable impact on its quality, safety and efficacy. Step 4: Decide on the final disposition of the medicines based on the manufacturer’s written assessment. If the manufacturer considers that their quality has been compromised, they must be destroyed in accordance with requirements. If the manufacturer provides data demonstrating that the excursion was within acceptable limits, the medicines may be released.

📘 Regulatory basis

GDP requires all deviations during transport to be investigated and recorded. For temperature-sensitive medicines, any temperature deviation must be assessed to ensure that product quality has not been affected before a decision is made on subsequent handling.

📗 Drew Tang's recommendations

Your SOP should include a procedure specifically for handling temperature excursions. Establish communication channels with your main medicine suppliers (manufacturers) in advance and find out whom to contact and what data format is required in the event of a temperature excursion. Do not decide for yourself that an excursion is ‘not serious’. All communications with the manufacturer and its final assessment must be kept on file in writing; these are the sole basis for your decision on how to proceed.

📕 Risk notice

Releasing a batch of medicines that has experienced a temperature excursion without supporting stability data from the manufacturer is an extremely dangerous gamble. You cannot guarantee the efficacy or safety of the medicine. If this is discovered by the regulatory authorities or causes harm to a patient, the consequences will be disastrous. Destroying a questionable batch is a financial loss; selling a problematic batch is a legal and ethical disaster.

Q343 · 为确保库存准确和防止混淆，有哪些库存管理的最佳实践？独立链接

Accurate inventory management is the foundation of GDP, and is key to effective traceability and error prevention. Best practices include: 1. **Clear location management**: Assign a unique code to every shelf, level and location in the warehouse, and link product information to the location code in the system. 2. **Status segregation**: Strictly separate inventory with different statuses, both physically and in the system, such as “released goods”, “quarantined goods pending examination”, “returned goods” and “non-conforming goods / goods pending destruction”, and use clear signs to identify each area. 3. **First in, first out / first expiry, first out (FEFO)**: Your Warehouse Management System (WMS) should support the FEFO principle to ensure that products with the earliest expiry dates are dispatched first. 4. **Cycle counting**: Replace the traditional annual full stocktake with ongoing counts of a small proportion of inventory daily or weekly. This helps identify and correct discrepancies earlier, keeping system data accurate. 5. **Batch-level management**: All inventory operations must be managed at batch level to ensure that the movement of every product batch is recorded accurately.

📘 Regulatory basis

GDP requires inventory records to accurately reflect actual stock, including quantities and batch numbers. It also requires measures to prevent mix-ups and cross-contamination and compliance with the FEFO principle. These requirements place high demands on inventory management accuracy.

📗 Drew Tang's recommendations

We strongly recommend that clients invest in a fully functional barcode-scanning Warehouse Management System (WMS). Requiring product barcodes and location codes to be scanned at every stage, including receipt, put-away, picking, checking and dispatch, can greatly reduce human error and keep inventory data accurate in real time. This is standard equipment for modern pharmaceutical warehousing.

📕 Risk notice

Disorganised inventory management is a breeding ground for dispatching the wrong goods or expired medicines. Inaccurate stock data means your traceability system is unreliable, and you may be unable to locate products quickly in an urgent recall. If inspectors find significant discrepancies between inventory records and actual stock during an inspection, they may consider your entire warehousing operation to be out of control.

Q344 · 用于GDP活动中的计算机化系统（如WMS, ERP）需要满足哪些验证和管理要求？独立链接

Computerised systems used to manage critical GDP activities (such as warehouse management systems (WMS), enterprise resource planning systems (ERP) and temperature and humidity monitoring systems) must themselves be controlled to ensure that the data they generate are reliable, accurate and secure. These systems require Computer System Validation (CSV), with documented evidence demonstrating that they consistently meet their intended functions and regulatory requirements throughout their lifecycle. CSV generally follows the GAMP 5 (A Risk-Based Approach to Compliant GxP Computerized Systems) framework. Key management requirements include: 1. **Data integrity**: the system must be designed to ensure compliance with the ALCOA+ principles; 2. **Audit trail**: the system must automatically record all activities relating to the creation, modification and deletion of GxP data, including timestamps and operator information; 3. **Access controls**: grant users the minimum system access necessary for their roles and responsibilities; 4. **Backup and recovery**: validated procedures must be in place to back up data regularly and restore it reliably when required; 5. **Change control**: any changes to the system (such as software upgrades or configuration changes) must be managed through a formal change control procedure.

📘 Regulatory basis

GDP expressly requires that the suitability of a computerised system be demonstrated before it is used, usually through validation. The system must prevent unauthorised access or modification, provide an audit trail and allow data backup. Annex 11 of the EU GDP guidelines and US FDA 21 CFR Part 11 are generally accepted standards in this area.

📗 Drew Tang's recommendations

When procuring a new system, make “support for GxP compliance” a key selection criterion. Ask the supplier to provide relevant documentation on its software development and testing. For cloud services (SaaS), you need to audit the service provider's quality system and security measures. CSV is a specialist field; if you lack in-house experience, consider seeking external expert support to plan and carry out validation activities.

📕 Risk notice

Using an unproven, “black-box” computer system to manage your pharmaceutical stock and quality data is unacceptable to regulators. If your system lacks an audit trail, you will be unable to explain any changes to the data. An uncontrolled computer system is a major source of risk to data integrity and may be sufficient for the entire quality system to be judged non-compliant.

Q345 · 什么是留存样品（Retention Sample）？药品批发商需要保存吗？独立链接

A retention sample is a representative sample taken and kept from each batch of medicines. Its main purpose is to ensure that, in the event of a product quality complaint, suspected counterfeit medicines or an investigation, an original-condition sample identical to the distributed product is available for examination and testing. Under GMP, medicine manufacturers must retain sufficient samples of every batch released from the factory. Hong Kong GDP regulations do not require pharmaceutical wholesalers to retain samples of all products. However, in certain circumstances—for example, where a wholesaler has carried out an operation that may affect the integrity of product packaging (such as relabelling), or where required under a quality agreement with the manufacturer—the wholesaler may also need to retain samples.

📘 Regulatory basis

The PIC/S GMP Guide sets out clear and detailed requirements for manufacturers to retain samples. Hong Kong's GDP guidelines do not impose the same requirement on wholesalers, placing this responsibility mainly on manufacturers.

📗 Drew Tang's recommendations

Although this is not a statutory requirement, we recommend that wholesalers clearly allocate responsibility for retaining samples and specify how to obtain them in quality agreements with their main suppliers. You need to ensure that, when necessary, you can quickly obtain a retained sample of a particular batch from the manufacturer to support an investigation. For products that you have repackaged, for example, we strongly recommend retaining samples yourself, as you determine the product’s final state.

📕 Risk notice

If neither the manufacturer nor your company has retained a sample when handling a quality complaint, the investigation will be at a serious disadvantage. You will lack the most direct physical evidence for assessing whether the complaint is genuine or identifying the root cause. While this does not in itself constitute a breach by the wholesaler, it will significantly undermine your ability to handle quality incidents.

Q346 · 在设计或改造药品仓库时，有哪些关键的GDP布局要求需要考虑？独立链接

The core design principles for a GDP-compliant warehouse layout are to ensure clear goods flows, prevent mix-ups and cross-contamination, and provide suitable storage conditions. Key layout requirements include: 1. **Functional zoning**: clearly separate, physically or by other effective means, areas such as goods receipt, quarantine pending examination, storage of released goods, non-conforming goods, returns, recalled goods and dispatch. 2. **One-way flow**: design sensible goods-flow routes so that, as far as possible, medicines move in one direction from receipt to dispatch, avoiding unnecessary backtracking and crossovers. 3. **Adequate space**: ensure that all areas have enough space for orderly storage and operations, avoiding excessive stacking or blocked passageways. 4. **Environmental controls**: areas requiring special storage conditions, such as refrigeration, protection from light or ventilation, should be specifically designed and equipped with suitable facilities. 5. **Security**: offices, rest areas and other non-operational areas should be separated from medicine storage areas. Storage areas for controlled medicines require additional security measures.

📘 Regulatory basis

Chapter 3, “Premises and Equipment”, of the Good Distribution Practice (GDP) for Medicinal Products sets out clear requirements for the design and layout of storage areas, emphasising the importance of functional segregation, preventing mix-ups and cross-contamination, and providing appropriate storage conditions.

📗 Drew Tang's recommendations

When planning the warehouse layout, draw a detailed floor plan showing all functional areas and the flow of goods. This plan will be an important document for demonstrating your design approach to the regulatory authorities. When designing the receiving and dispatch areas, consider providing a sheltered area to protect medicines from adverse weather during loading and unloading. The warehouse floors, walls and ceilings should be made of materials that are easy to clean.

📕 Risk notice

A warehouse with a disorganised layout and unclear functional zones is a major problem area in a GDP inspection. If released goods, non-conforming goods and returned goods are stored together, inspectors will immediately conclude that your system presents a serious risk of medicine mix-ups and incorrect dispatch. This could directly result in a failed inspection or a requirement for you to suspend operations immediately and carry out remedial work.

Q347 · 在对一个新的药品供应商进行首次资质审核时，应执行哪些关键步骤？独立链接

Initial qualification of new suppliers is the first safeguard for ensuring that your supply chain is lawful and compliant at source, and must be conducted with great care. Key steps include: 1. **Document review**: Ask the supplier for a complete set of qualification documents, including its business licence, medicines trading licence (such as a wholesale licence) and, where applicable, the manufacturer’s GMP certificate. Verify that these documents are authentic and valid. 2. **Questionnaire**: Send the supplier a detailed quality system questionnaire to understand its QMS, including its personnel, facilities, SOP system, temperature-control capabilities and recall procedures. 3. **Risk assessment**: Use the document review and questionnaire results to conduct an initial assessment of the supplier’s potential compliance risk. 4. **On-site audit (for high-risk suppliers)**: For critical, high-risk suppliers—for example, the sole supplier from which you plan to source a core product—an on-site audit is strongly recommended to verify in person that its operations match the documents. 5. **Approval and agreement**: Only after all review steps have been completed satisfactorily should the supplier be added to the “Approved Supplier List” and a formal quality agreement signed.

📘 Regulatory basis

Chapter 5, “Operations”, of the Good Distribution Practice (GDP) for Medicinal Products expressly provides that wholesalers must procure medicines from suppliers holding the relevant licences. You are responsible for verifying this through a formal qualification procedure.

📗 Drew Tang's recommendations

Establish a standardised new-supplier qualification SOP and checklist to ensure every assessment is thorough and consistent. Do not rely solely on documents supplied by the supplier; cross-check the authenticity of its licence using public government databases, such as the Department of Health website. Treat supplier qualification as an investment, not a cost. A sound start can prevent countless problems later.

📕 Risk notice

Purchasing medicines from a new supplier based solely on commercial negotiations, without adequate qualification checks, is extremely risky. You may unknowingly obtain medicines through an unlicensed or non-compliant channel, or even purchase counterfeit medicines. If discovered, you may face serious legal and regulatory penalties for failing to fulfil your due diligence responsibilities.

Q348 · 如何对一条新的药品运输路线进行风险评估？独立链接

Risk assessment of a new transport route is a key step in ensuring that medicines are adequately protected on a new, unvalidated route. The assessment should be systematic and documented: 1. **Define the route and products**: Specify the starting point, destination and key transit points, as well as the specific storage requirements of the medicines to be transported (such as room temperature or cold chain). 2. **Identify risk factors**: Brainstorm all risks that could affect medicine quality. These include transit time, climatic conditions in the regions along the route (extreme heat or cold), the likelihood of traffic delays, customs inspection procedures and duration, storage conditions at transit points, and security risks during transport. 3. **Assess risk levels**: For each identified risk, assess its probability of occurrence and the severity of its impact on medicine quality if it occurs. Combine the two to determine the level of each risk (high, medium or low). 4. **Establish control measures**: Develop specific control and mitigation measures for all medium- and high-level risks. For example, a validated passive cooler may be needed to address heat risk, while extra cool packs may be required in the packaging to mitigate delay risk. 5. **Validation and monitoring**: During the first commercial shipment or a simulated shipment, use temperature loggers to verify the effectiveness of the control measures.

📘 Regulatory basis

GDP requires transport processes to be designed and controlled on the basis of risk assessment. Although no specific assessment method is prescribed, using a structured risk assessment process is the best way to demonstrate that you have met this requirement.

📗 Drew Tang's recommendations

Develop a standardised template for transport-route risk assessments. Involve personnel from Quality, Logistics and Procurement in the assessment to gain a broader perspective. Remember to consider the “human factor”, such as whether staff at transit points have received relevant training. Retain the complete risk assessment report as the basis for your decision to select a particular transport arrangement.

📕 Risk notice

Sending medicines along a new, particularly long-distance international, transport route without conducting a risk assessment is like walking blindfolded into the unknown. You cannot anticipate or control the various incidents that may occur in transit. If a problem arises (such as a cold-chain failure), your lack of prior risk assessment and control planning may be considered serious negligence.

Q349 · 一份详尽的内部审核（自我检查）报告应包含哪些内容？独立链接

An internal audit report is a key document for recording audit findings and driving subsequent improvements; its quality directly affects the effectiveness of the audit. A detailed report should be clearly structured and specific. It should include at least the following sections: 1. **Basic information**: unique audit reference, audit date, scope (such as “storage operations” or “document system”), audit criteria (such as GDP guidance or company SOPs), auditor’s name and the department audited. 2. **Audit summary**: a brief overview of the audit and its main conclusions. 3. **Audit findings**: the core of the report. Clearly list each non-conformity (deficiency) separately. Describe the specific facts observed in detail (“where I was and what I saw”) and cite the specific legislative or SOP provision breached. 4. **Deficiency grading**: grade each deficiency according to its potential impact on product quality and regulatory compliance (for example, “critical”, “major” or “minor”). 5. **Recommendations (optional)**: the auditor may suggest improvements, but the audited department should determine the final corrective actions. 6. **Report distribution list and conclusion**.

📘 Regulatory basis

Self-inspections must be recorded under the Good Distribution Practice (GDP) for Medicinal Products, and the records should include all observations and proposed corrective measures. A structured report is the standard way of meeting this requirement.

📗 Drew Tang's recommendations

When describing audit findings, remain objective and fact-based, and avoid subjective or accusatory language. A good finding should enable anyone reading it to recreate the situation. For example, instead of writing ‘staff training was inadequate’, write ‘In the third-floor warehouse, staff member Zhang San did not follow the picking steps in SOP-W-005. When asked, he said that he was not familiar with the SOP.’ Such a description is compelling and effectively points to the root cause.

📕 Risk notice

An internal audit report that is vague and lacking in detail is ineffective. It does not provide clear input for subsequent CAPA, nor does it demonstrate to the regulator that a thorough, professional self-inspection was carried out. If the report always says “everything is fine”, or the issues it raises are trivial, the regulator may suspect that your internal audits are merely a formality.

Q350 · 对于不合格的、需要销毁的药品，应遵循怎样的最终处置（Final Disposition）程序？独立链接

Destroying non-conforming medicines is the final step in quality management and requires equally strict controls and records to ensure that the medicines do not accidentally re-enter the market. The disposal procedure should include: 1. **Formal decision**: The decision to destroy must be made by an authorised person in the Quality Department (such as the RP), who must sign a written destruction instruction. 2. **Segregation and records**: Medicines awaiting destruction should be kept in a secure, dedicated area clearly labelled ‘Awaiting Destruction’. Before destruction, check and record the name, batch number and quantity of the medicines one final time. 3. **Select a qualified destruction service provider**: Medicines must not be disposed of like ordinary rubbish. A specialist company qualified and authorised by the government to handle pharmaceutical waste must be engaged. You should verify its qualifications. 4. **Secure transport**: Transport the medicines awaiting destruction securely to the service provider’s premises and keep a record of the transport. 5. **Witnessing and certification**: If possible, send a staff member to witness the destruction on site. Whether or not it is witnessed, you must obtain a formal Certificate of Destruction from the service provider. This document is key legal evidence that the medicines have been disposed of lawfully. 6. **Update inventory**: Once destruction is confirmed, reduce the quantity of the medicines to zero in your inventory management system and archive all relevant records.

📘 Regulatory basis

GDP requires non-conforming goods to be segregated and properly handled. Although it does not set out the destruction process in detail, environmental laws and waste management regulations impose strict requirements on the disposal of medicines. You are responsible for ensuring that the destruction process complies with all relevant laws and regulations.

📗 Drew Tang's recommendations

Enter into a long-term contract with one or more qualified medicine destruction service providers. Set out the entire destruction process in your SOP and create a “medicine destruction record pack” containing all relevant documents, including destruction instructions, inventory records, transport documents and the final certificate of destruction. This creates a complete, traceable evidence trail.

📕 Risk notice

Carelessly discarding non-conforming medicines is extremely dangerous and irresponsible. It not only seriously breaches environmental regulations, but may also result in the medicines being found by others and misused or resold, creating a public safety risk. If you cannot provide lawful proof of destruction, you will be unable to demonstrate to the regulator that you have properly handled the non-conforming goods. This may be regarded as a loss of ultimate control over your supply chain.

Hong Kong Drug Licence FAQs

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