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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Q273 · 在我的预算中，应该为市场推广和业务发展预留多少比例的资金？独立链接

The proportion of your budget allocated to marketing and business development depends on your business model. For a licensed pharmacy selling directly to consumers, marketing is essential. Initially, you may need to invest 10% to 20% of projected annual revenue in areas such as brand building, community outreach and online promotion. For a pharmaceutical wholesaler that mainly conducts B2B business, the proportion may be lower, around 3% to 5%, with a focus on building relationships with hospitals, clinics and pharmacy chains. The costs would mainly cover building a sales team, attending industry exhibitions and maintaining customer relationships. A manufacturer of proprietary Chinese medicines will need to invest more in brand building and educating doctors.

📘 Regulatory basis

The Undesirable Medical Advertisements Ordinance (Cap. 231) strictly regulates the advertising of medicines. Advertisements must not suggest that a medicine can prevent or treat certain serious diseases, or contain false or misleading information. All your promotional activities must comply with this legal framework.

📗 Drew Tang's recommendations

In the pharmaceutical industry, the most effective “marketing” is to build a professional and trustworthy reputation. We recommend allocating more of your budget to activities that enhance your professional image, such as holding health seminars, providing professional medication advice, and ensuring that your pharmacist team has up-to-date professional knowledge. Word of mouth is the best advertising.

📕 Risk notice

The consequences of placing unlawful advertisements are very serious. If found guilty of breaching the Undesirable Medical Advertisements Ordinance, you may face not only substantial fines and imprisonment, but also serious damage to your company’s public image and reputation, and your eligibility to hold a licence may even be affected. Always seek legal advice before planning any promotional activity.

Q280 · 申请中成药注册（pCm）的费用大概是多少？这与申请牌照有何不同？独立链接

The fees for applying for “proprietary Chinese medicine registration” (Proprietary Chinese Medicine Registration, pCm) are entirely different from the costs of applying for an operating licence. A licence (such as a wholesale or retail licence) authorises business activities at premises, whereas proprietary Chinese medicine registration is a market authorisation for an individual product. The statutory fee for an application for one proprietary Chinese medicine registration is HKD 9,290. This is only the government fee; the actual cost is much higher. A range of tests and studies must be conducted on the product to demonstrate its safety, quality and efficacy, including, but not limited to, tests for heavy metals and toxic elements, pesticide residues, microbial limits and stability. These tests may cost tens of thousands or even hundreds of thousands of Hong Kong dollars.

📘 Regulatory basis

The Chinese Medicine Ordinance (Cap. 549) requires all proprietary Chinese medicines sold in Hong Kong to be registered with the Chinese Medicines Board under the Chinese Medicine Council of Hong Kong. They may only be marketed after obtaining a Certificate of Registration of Proprietary Chinese Medicine (HKC-XXXXX).

📗 Drew Tang's recommendations

Before deciding whether to apply to register a proprietary Chinese medicine, you must conduct a thorough market assessment and cost-benefit analysis. The investment in research and registration for an individual product must be recoverable through future sales profits. We recommend prioritising products with clear market demand, a distinctive formula or a successful track record in other regions.

📕 Risk notice

The greatest risk is investing heavily in testing and registration costs, only for the application to be refused because the safety or quality data does not meet requirements. Alternatively, even if the product is successfully launched, poor marketing may result in weak sales and prevent recovery of the initial investment. Each product registration is an independent investment decision and requires the same level of prudence.

Q282 · 在做财务预测时，我应该如何设定一个实际的药品销售毛利率？独立链接

Setting a realistic gross profit margin for medicine sales is central to financial forecasting. This rate varies widely in the pharmaceutical sector, depending on your business type and product mix. Wholesalers or pharmacies dealing in patented and branded medicines may achieve higher margins of 15% to 30% because of brand premiums. Margins may be lower, at 5% to 15%, for generic medicines or ordinary health products in highly competitive markets. Margins may be higher for proprietary Chinese medicines, particularly products with exclusive formulations. A practical approach is to review the financial performance of comparable competitors in the market (if they are listed companies) and set a rate based on this together with your procurement costs and pricing strategy.

📘 Regulatory basis

Hong Kong is a free market, and the Government does not directly regulate medicine prices or gross profit margins. However, your pricing practices must still comply with the Competition Ordinance (Cap. 619), which prohibits collusion with other competitors to fix prices and abuse of a substantial degree of market power.

📗 Drew Tang's recommendations

We recommend that you take a conservative approach to financial projections. You could initially set a relatively low gross margin target and conduct sensitivity analysis to test the company’s profitability and cash flow at different gross margin levels. Once the business is stable, gradually improve the gross margin by optimising procurement and increasing the added value of your services.

📕 Risk notice

Overly optimistic gross margin forecasts are a common reason for business plans to fail. They directly lead to overestimated revenue and underestimated costs, ultimately creating a serious funding shortfall. You must account for real-world factors such as market competition, customers’ bargaining power and potential pressure to reduce prices.

Q288 · 我计划同时经营西药批发和中成药批发，是否需要为这两个业务设立独立的财务账目？独立链接

Although the law does not require separate legal entities or bank accounts for different business lines within the same company, from a management and compliance perspective we strongly recommend setting up separate “cost centres” or “profit centres” in your accounting system for wholesale of western medicines and wholesale of proprietary Chinese medicines. This means you should be able to track and distinguish clearly the sales revenue, procurement costs, inventory value and related operating expenses for each. This gives you a more detailed management perspective and allows you to assess the profitability of each business area accurately.

📘 Regulatory basis

Western medicines and Chinese medicines are regulated by the Drug Office, Department of Health and the Chinese Medicine Council of Hong Kong respectively, under different regulatory frameworks (Cap. 138 vs Cap. 549). Providing clear, separate business records during inspections by the respective regulatory authorities is an important part of demonstrating compliant operations.

📗 Drew Tang's recommendations

Clear separation of accounts can help you make better-informed business decisions. For example, if you find that the profit margin for your proprietary Chinese medicine business is far higher than that for your Western medicine business, you may decide to allocate more resources to the former, or vice versa. Without separate accounting, all your financial data is a muddle and cannot be analysed effectively.

📕 Risk notice

If accounts are unclear or mixed together, a serious compliance issue in one business segment (for example, the discovery of illegally imported Western medicines) may affect your company’s entire licensing eligibility, including its otherwise compliant Chinese medicine business. Financial segregation can provide a firewall to some extent and reduce the likelihood of risk spreading.

Q364 · 我们是一家中成药制造商，在日常生产中，对原材料（中药材）的检验有什么要求？独立链接

As a licensed manufacturer of proprietary Chinese medicines, quality control of raw materials is the first step in ensuring the safety and efficacy of the finished product, and is a core GMP requirement. Each batch of Chinese herbal medicines purchased must be rigorously tested before being used in production. The tests must include at least: 1. Identification of origin, confirming that the species is correct and that there is no confusion or adulteration. 2. Macroscopic examination, using traditional methods such as visual inspection, touch, smell and taste to check whether the appearance, colour and odour of the medicines conform to pharmacopoeial standards. 3. Microscopic identification, where necessary, using a microscope to examine the tissue structure of the medicines. 4. Physicochemical identification, including tests such as thin-layer chromatography (TLC), with comparison against the chromatogram of the relevant reference standard. 5. Safety testing for harmful substances such as heavy metals, pesticide residues and aflatoxins, to ensure that their levels are within statutory limits. All testing must be supported by detailed records and reports.

📘 Regulatory basis

The Good Manufacturing Practice Guide for Proprietary Chinese Medicines in Hong Kong, issued by the Chinese Medicine Council of Hong Kong, sets out detailed requirements for the receipt, sampling, testing and approval for release of raw materials. The requirements of the Chinese Medicine Ordinance (Cap. 549) must also be met.

📗 Drew Tang's recommendations

We recommend that manufacturers establish a reliable supplier audit and evaluation system to control the quality of Chinese herbal medicines at source. For certain critical or high-risk herbs, consider conducting on-site audits. In addition, retain a sample from every batch of herbs until one year after the expiry date of the corresponding finished product; this is vital for traceability investigations in the event of subsequent quality issues. If your in-house testing capability is limited, you can commission a third-party laboratory accredited by HOKLAS to carry out testing.

📕 Risk notice

Using Chinese herbal medicines for production without testing them or after they have failed testing is a serious GMP breach. This may result in an entire batch being deemed non-conforming and destroyed, causing substantial financial losses. If raw material issues, such as excessive heavy metals or toxic substances, cause harm to consumers through the finished product, the company may face a product recall, legal action and criminal prosecution, and its licence may also be at risk.

Q392 · 我们是一家中成药零售商，在销售附表一的中药材（如附子、川乌）时，有哪些特殊的日常监管要求？独立链接

As a licensed proprietary Chinese medicine retailer, you must meet stricter regulatory requirements than those applying to ordinary Chinese herbal medicines when selling toxic Chinese herbal medicines listed in Schedule 1, in order to protect public safety. In day-to-day operations, you must: 1. Obtain a prescription from a registered Chinese medicine practitioner before dispensing and selling; sales without a prescription are strictly prohibited. 2. Keep a dedicated “toxic Chinese herbal medicine sales register” recording each transaction in detail, including the date, patient's name and address, prescribing Chinese medicine practitioner's name, name of the medicine and quantity sold. 3. Store these medicines in a dedicated locked cabinet, clearly separated from other medicines to prevent confusion or misuse. 4. Ensure that dispensing is carried out by a registered Chinese medicine practitioner or a Chinese medicine dispensing assistant under the supervision of a registered Chinese medicine practitioner. 5. Clearly mark the medicine container with the words “poison” or “Toxin” and other warning information.

📘 Regulatory basis

The Chinese Medicine Ordinance (Cap. 549) and its subsidiary legislation, the Chinese Medicines Regulation, set out strict requirements for the retail, labelling, storage and record-keeping of Chinese herbal medicines listed in Schedule 1.

📗 Drew Tang's recommendations

We recommend that retailers provide dedicated training to all staff to ensure that they can accurately identify Schedule 1 Chinese herbal medicines and understand the relevant sales restrictions. The register should be checked daily to ensure that no entries are missing. When receiving prescriptions from Chinese medicine practitioners, check them carefully and proactively contact the prescribing practitioner for confirmation if anything is in doubt (for example, an unusually high dose). This is both a compliance requirement and a professional responsibility to protect patients and yourself.

📕 Risk notice

Illegal sale of Schedule 1 toxic Chinese herbal medicines is a serious criminal offence. Investigators from the Chinese Medicine Council of Hong Kong may conduct undercover operations. If a breach is established, the shop and persons responsible may face prosecution and substantial fines, and the professional qualifications of the Chinese medicine practitioner or dispenser concerned may also be suspended or revoked. This is an absolute red line.

Q405 · 我的中成药批发商牌照持牌公司发生了股权变更，是否需要向中医药管理委员会（CMRO）申报？独立链接

Yes, this is absolutely required. Whenever the directors or shareholding structure of a licensed company wholesaling proprietary Chinese medicines changes, you must notify the Chinese Medicines Board under the Chinese Medicine Council of Hong Kong in writing within 28 days of the change. You must submit details of the change, including identity documents for the new and former directors/shareholders and changes in shareholding percentages. Although a shareholding change does not necessarily require prior approval, notification after the event is mandatory. The Chinese Medicines Board will assess whether the change affects the company's effective control and management to ensure that it continues to meet the licensing requirements.

📘 Regulatory basis

Under the subsidiary legislation of the Chinese Medicine Ordinance (Cap. 549), licence holders are responsible for notifying the regulatory body of any significant change in the company’s control.

📗 Drew Tang's recommendations

We recommend seeking professional advice before any shareholding change transaction. We can help assess whether the background of a new shareholder may raise regulatory concerns and ensure that all notification documents are accurate, avoiding unnecessary scrutiny arising from improper notification.

📕 Risk notice

If you fail to report on time or provide false information, the Chinese Medicines Council has the authority to take disciplinary action against your licence, including issuing a warning letter, suspending the licence or, in extreme cases, revoking it.

Q407 · 作为持牌中药材零售商，哪些行为会被视为违规？独立链接

Common violations by licensed retailers of Chinese herbal medicines mainly fall into several categories. First, “adulteration or substitution”, meaning that the Chinese herbal medicines sold do not match the varieties indicated on the labels, or that other substances have been added. Second, non-compliant labelling, such as failing to state the name, origin, batch number or expiry date of the Chinese herbal medicines as required. Third, improper storage, with inadequate storage conditions to prevent deterioration, mould or contamination. Fourth, failing to record purchaser details as required when selling toxic Chinese herbal medicines listed in Schedule 1 or Schedule 2. Finally, operating beyond the scope of the licence, such as also selling proprietary Chinese medicines, is a violation.

📘 Regulatory basis

The Chinese Medicine Ordinance (Cap. 549) and its subsidiary legislation, particularly the Chinese Medicines Regulation, set out in detail the requirements for the retail of Chinese herbal medicines, labelling and storage.

📗 Drew Tang's recommendations

We recommend that clients establish a strict internal control system, including supplier audits, quality inspection of incoming goods (SOP), and clear labelling and stock management systems. Regular staff training is also essential to ensure that everyone understands the legal requirements.

📕 Risk notice

Any breach may result in disciplinary action by the Chinese Medicine Council. Serious breaches affecting public health, particularly the sale of adulterated or poisonous herbal medicines, may not only put the licence at risk of revocation but may also lead to criminal prosecution.

Q409 · 在什么情况下，违规经营药品会从行政处罚上升到刑事检控？独立链接

Whether a breach in the course of dealing in medicines will lead to criminal prosecution depends mainly on its nature and seriousness. Serious offences involving public health and safety, or conduct with an obvious fraudulent intent, are highly likely to result in criminal prosecution. Examples include operating any type of medicine business without a licence; selling or possessing unregistered pharmaceutical products (“counterfeit medicines”); selling proprietary Chinese medicines containing undeclared Western medicine ingredients; illegally selling antibiotics or dangerous drugs; and adulterating medicines with harmful substances. Such cases are usually investigated jointly by the Department of Health and the Commercial Crime Bureau of the Hong Kong Police Force, with the Department of Justice deciding whether to prosecute.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138), the Chinese Medicine Ordinance (Cap. 549) and the Undesirable Medical Advertisements Ordinance (Cap. 231) all contain provisions on serious offences that may lead to criminal prosecution.

📗 Drew Tang's recommendations

The distinction between an administrative breach and a criminal offence is sometimes blurred. Our principle is to never cross the red lines involving “fake” (unregistered products), “poisons” (dangerous drugs) or “deception” (false claims). Compliant operations are the only safeguard.

📕 Risk notice

The consequences of a criminal conviction go far beyond a fine. The person-in-charge may face imprisonment and acquire a permanent criminal record. The company’s reputation will be completely destroyed, making it virtually impossible to establish itself again in the pharmaceutical industry.

Q415 · 我的中成药制造商牌照，如果厂房进行内部装修或改动，是否需要事先批准？独立链接

This depends on the nature and scale of the alterations. If renovation or alteration works affect the production process, clean-area layout, air purification system, storage conditions or any important facilities relevant to the Hong Kong Good Manufacturing Practice for Proprietary Chinese Medicines (GMP), you must submit a change application to the Chinese Medicines Board under the Chinese Medicine Council of Hong Kong and obtain approval before commencing work. You will need to submit detailed plans and an explanation of the changes, explaining their purpose and how compliance with GMP will be maintained afterwards. The Chinese Medicines Board will usually arrange an on-site inspection after the work is completed.

📘 Regulatory basis

The Chinese Medicine Ordinance (Cap. 549) and the GMP guidelines for proprietary Chinese medicines require the premises and facilities of licensed manufacturers to remain compliant with good manufacturing practice.

📗 Drew Tang's recommendations

Before planning any factory alterations, we strongly recommend that you consult a professional adviser. Rengangyongsheng (Hong Kong) Limited can help assess whether the proposed alterations comply with GMP requirements and prepare the application documents for submission to the Chinese Medicines Board, helping you avoid wasting investment on an unsuitable design.

📕 Risk notice

Making major changes without prior approval may be classified as a serious non-compliance at the next routine inspection. This may not only affect your GMP certification status but could also lead to suspension of the Manufacturer of Pharmaceutical Products licence until corrective action has been completed.

Q437 · 我是否可以将药品存放在持牌地址以外的地方，例如迷你仓？独立链接

Absolutely not. Under Hong Kong law, all regulated medicines, whether Western medicines or proprietary Chinese medicines, must be stored at licensed premises specified on the licence and approved by the regulatory authority. The facilities at these premises, including temperature and humidity controls, security systems and fire prevention measures, are subject to rigorous scrutiny to ensure the quality and safety of the medicines. Unapproved external storage locations, such as offices, homes or mini-storage units, do not meet statutory storage requirements. Storing medicines at these locations is a serious breach.

📘 Regulatory basis

Both the Good Distribution Practice (GDP) for Wholesale Dealers in Medicines and guidance such as the GMP for proprietary Chinese medicines strictly require medicines to be stored at qualified premises.

📗 Drew Tang's recommendations

If your licensed warehouse does not have sufficient capacity, the only lawful solution is to apply to expand the area of the existing licensed premises or apply for a new, suitably qualified licensed warehouse. Rengangyongsheng (Hong Kong) Limited can assist you in finding suitable storage space and completing the licence application or change procedure.

📕 Risk notice

Storing medicines at an unapproved location not only puts their quality at risk; more seriously, if this is discovered, the regulatory authorities may consider that you are attempting to conceal or distribute medicines of unknown origin, triggering a serious loss of trust and disciplinary action.

Q439 · 针对中成药的监管，和西药相比，在违规处罚方面有什么主要不同？独立链接

Although proprietary Chinese medicines and Western medicines are regulated by different bodies (the Chinese Medicine Council of Hong Kong and the Pharmacy and Poisons Board), their regulatory philosophies and penalty principles are similar, with the protection of public health as the primary objective. The main differences lie in the specific legal bases and certain types of non-compliance unique to each. For example, regulation of proprietary Chinese medicines focuses particularly on quality standards for “heavy metals and toxic elements”, “pesticide residues” and “microbial limits”. Breaches of these standards are serious forms of non-compliance specific to proprietary Chinese medicines. Proprietary Chinese medicines are also subject to the issue of “unregistered proprietary Chinese medicines”, similar to “unregistered pharmaceutical products” in the case of Western medicines. In general, penalties for serious offences such as unlicensed operations and the sale of counterfeit or substandard products are severe for both, including substantial fines and imprisonment.

📘 Regulatory basis

The Chinese Medicine Ordinance (Cap. 549) is the main legal framework for regulating proprietary Chinese medicines, while Western medicines are primarily regulated under the Pharmacy and Poisons Ordinance (Cap. 138).

📗 Drew Tang's recommendations

Whether you deal in Chinese or Western medicines, the core principles of compliance are the same: ensure that products are safe, effective and of controlled quality, and that their sources and destinations are clear and traceable. Our compliance consultancy is tailored to each client's specific business type.

📕 Risk notice

Do not assume that Chinese medicines are subject to more lenient regulation than Western medicines. In recent years, Hong Kong has continued to tighten safety standards and enforcement for proprietary Chinese medicines, particularly in tackling products containing undeclared Western medicine ingredients or excessive levels of heavy metals.

Q443 · 我是否可以在同一个持牌处所内，同时经营西药批发和中成药批发业务？独立链接

Yes, but you must apply for and hold two different licences for the premises: a Wholesale Dealer Licence issued by the Department of Health and a wholesaler’s licence for proprietary Chinese medicines issued by the Chinese Medicine Council of Hong Kong. In addition, you must establish clearly segregated physical areas within the premises for storing Western medicines and proprietary Chinese medicines separately, to prevent cross-contamination and confusion. Two separate Quality Management Systems and record-keeping systems are also essential, each meeting the GDP requirements for Western medicines and the relevant requirements for proprietary Chinese medicines. During inspections, the regulatory authorities will independently inspect each area and system.

📘 Regulatory basis

Western medicines and proprietary Chinese medicines are regulated under different legislation and by different regulatory authorities. They therefore require separate licences and compliance systems, even when operated at the same physical address.

📗 Drew Tang's recommendations

RGYS may assist with document preparation and project coordination within the written scope of services; the respective responsible parties must verify personnel qualifications and statutory roles and take responsibility for professional judgements, while approval is determined independently by the competent authority. The key is careful planning at an early stage to ensure that the warehouse layout, workflows and document systems are clearly separated and independently compliant from the outset, avoiding confusion in subsequent operations.

📕 Risk notice

If Western medicines and proprietary Chinese medicines are treated as one in management, for example by sharing stock areas or combining records, this will constitute a serious non-compliance in the assessment of both licences and may put both licences at risk.

Q491 · 如何区分中成药与健康食品在香港的监管分类？独立链接

In Hong Kong, proprietary Chinese medicines are generally regarded as medicines and are regulated under the Pharmacy and Poisons Ordinance (Cap. 138). They require a pharmaceutical licence and must comply with requirements on medicine safety, ingredients and labelling. Health foods do not fall within the category of medicines and are primarily regulated under the Trade Descriptions Ordinance (Cap. 362) and the Food Safety Ordinance (Cap. 612), with an emphasis on food safety and accurate labelling. If a proprietary Chinese medicine contains medicinal ingredients or makes therapeutic claims, it must go through the pharmaceutical licensing approval process; health foods must not claim to treat or prevent disease. Correct classification helps businesses avoid compliance risks.

📘 Regulatory basis

Section 2 of the Pharmacy and Poisons Ordinance (Cap.138), section 3 of the Food Safety Ordinance (Cap.612)

📗 Drew Tang's recommendations

We recommend that businesses clearly determine a product's classification before promoting it and avoid using pharmaceutical advertising inappropriately. Where necessary, consult the Drug Office to ensure the correct submission category.

📕 Risk notice

Misrepresenting a proprietary Chinese medicine as a health food may result in the product being detained, fines or even criminal liability, seriously damaging the brand's reputation.

Q492 · 跨境销售中成药时，香港药牌的管辖范围具体包括哪些？独立链接

Hong Kong’s pharmaceutical licensing regime covers medicines sold, supplied, distributed or displayed in Hong Kong, including proprietary Chinese medicines. Cross-border sales involve importing products into Hong Kong; the medicines must hold valid Hong Kong pharmaceutical licences and comply with local labelling and safety standards. Sales into the Hong Kong market through online platforms are also regarded as supply in Hong Kong and must be compliant. Rengangyongsheng (Hong Kong) Limited assists clients throughout the process with import permits, pharmaceutical licence applications and subsequent compliance oversight, to support the lawful circulation of proprietary Chinese medicines across borders.

📘 Regulatory basis

Sections 4 and 7 of the Pharmacy and Poisons Ordinance (Cap.138), Drug Office guidance

📗 Drew Tang's recommendations

Plan pharmaceutical licence applications in advance for cross-border business to avoid products being detained or investigated because of unlicensed operations or non-compliant labelling. Rengangyongsheng (Hong Kong) Limited’s one-stop service can help simplify the process.

📕 Risk notice

Importing or selling proprietary Chinese medicines without authorisation is illegal and may result in product seizure, fines and criminal prosecution, affecting the company’s long-term operations.

Q495 · 中成药进口至香港时，必须满足哪些主要合规要求？独立链接

When importing proprietary Chinese medicines into Hong Kong, a valid Hong Kong pharmaceutical licence must be held and the import licence requirements under the Pharmacy and Poisons Ordinance (Cap. 138) must be met. Product ingredients, formulae and pharmacological information must be submitted for review by the Drug Office to ensure that the ingredients are safe and the efficacy claims reasonable. Imports must be declared and undergo health inspection. Labels must state the ingredients, directions for use, contraindications and production batch number in both Chinese and English. Rengangyongsheng (Hong Kong) Limited assists clients in preparing complete documents and coordinating imports and pharmaceutical licence applications to help ensure compliant and prompt release.

📘 Regulatory basis

Sections 7 and 14 of the Pharmacy and Poisons Ordinance (Cap.138), Import and Export (General) Regulations (Cap.60)

📗 Drew Tang's recommendations

We recommend preparing scientific information and test reports in advance and working with the Rengangyongsheng (Hong Kong) Limited professional team to improve processing efficiency and prevent delays caused by insufficient documentation.

📕 Risk notice

Importing proprietary Chinese medicines without a licence is illegal and may result in goods being detained, fines and criminal liability, damaging the company’s reputation.

Q496 · 近年来香港跨境医药行业有哪些重要趋势值得关注？独立链接

In recent years, Hong Kong’s cross-border pharmaceutical industry has seen trends towards digital transformation, tighter regulation and more diverse market demand. With the rise of e-commerce, regulation of online pharmaceutical sales has tightened, bringing stricter requirements for pharmaceutical licences and labelling. At the same time, increased consumer concern about the quality and safety of proprietary Chinese medicines and health products is driving the development of industry standards. Rengangyongsheng (Hong Kong) Limited closely monitors policy developments and helps clients adapt to digital regulatory requirements, bring products to market compliantly and meet changing market needs.

📘 Regulatory basis

Relevant notices from the Drug Office, Department of Health, Hong Kong Special Administrative Region Government, and updates to PPB codes of practice

📗 Drew Tang's recommendations

We recommend that businesses proactively upgrade their compliance systems, monitor policy changes and use RGYS's professional services to plan ahead and seize market opportunities.

📕 Risk notice

Failure to keep up with regulatory updates or digital regulatory requirements may create compliance gaps, affecting the continued sale of products and the company’s reputation.

Q500 · 仁港永胜对中成药及保健品的行业未来发展有哪些见解？独立链接

Rengangyongsheng (Hong Kong) Limited considers that demand for proprietary Chinese medicines and health supplements in the Hong Kong market is growing steadily, with consumers increasingly seeking high quality and safety assurance. In future, the sector will place greater emphasis on scientific validation, standardised manufacturing and digital compliance management. Cross-border trade will benefit from policy optimisation and greater regulatory transparency. We recommend that businesses embrace innovation, strengthen communication with regulators, and improve product quality and compliance systems to address changing market conditions and regulatory requirements and gain a competitive edge.

📘 Regulatory basis

Drug Office, Department of Health policy guidance and relevant implementation details under the Pharmacy and Poisons Ordinance (Cap.138)

📗 Drew Tang's recommendations

We recommend that businesses focus on product development and regulatory compliance and use Rengangyongsheng (Hong Kong) Limited's professional services to optimise their product portfolio and support sustainable, healthy market development.

📕 Risk notice

Failure to keep up with industry trends and regulatory updates may result in restrictions on product sales, affecting the company’s future growth potential.

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