Question

1. 申请前准备

• 确定药品是否属于需要注册的药剂制品。
• 准备药品的注册资料，包括：
  • 药品的说明书、标签、包装等信息。
  • 药品的安全性、有效性和质量的数据。
  • 药品的生产工艺和质量控制资料。
  • 其他必要的文件。

2. 提交申请

• 向香港卫生署药物办公室提交药品注册申请。
• 申请资料必须完整、准确、符合香港的相关规定。

3. 审核

• 香港卫生署药物办公室会对申请资料进行审核。
• 如果审核发现问题，会要求申请人补充或修改资料。

4. 批准

• 如果审核合格，香港卫生署药物办公室会签发药品注册证书。
• 药品注册证书是药品在香港销售、要约出售、分销或管有的法定凭证。

5. 注册后

• 药品注册人必须遵守香港的相关法规，确保药品的安全、有效性和质量。
• 香港卫生署药物办公室会对注册药品进行定期检查和监督。

香港药品注册的一般时限如下：

• 新药：18-24个月
• 仿制药：12个月
• 通用名药：12个月
• 生物制品：270个月
• 传统中药：18-360个月

请注意，上述时间仅供参考，实际审批时间可能有所不同。

以下是一些可以帮助您缩短香港药品注册时间的建议：

• 在提交申请之前咨询香港卫生署药物办公室或专业的药品注册咨询机构。
• 确保您的申请资料完整、准确、符合香港的相关规定。
• 选择合适的注册路径。
• 与香港卫生署药物办公室保持密切沟通。

以下是一些香港药品注册的参考资料：

• 香港卫生署药物办公室网站：https://www.drugoffice.gov.hk/eps/do/en/level.html
• 藥劑製品/物質註冊申請指南：https://www.ppbhk.org.hk/
• 香港的藥物註冊簡介：https://www.dh.gov.hk/chs/useful/useful_registration/useful_registration.html

希望以上信息对您有所帮助。

Comments

Drug Registration Process in Hong Kong
The drug registration process in Hong Kong is overseen by the Hong Kong Department of Health (DH), and the specific steps are as follows:

1. Pre-application Preparation

Determine whether the drug is a pharmaceutical product that requires registration.
Prepare drug registration materials, including:
Information on the drug's leaflet, label, packaging, etc.
Data on the safety, efficacy, and quality of the drug.
Drug manufacturing process and quality control materials.
Other required documents.
2. Submit Application

Submit the drug registration application to the Drug Office of the Hong Kong Department of Health.
Application materials must be complete, accurate, and comply with relevant Hong Kong regulations.
3. Review

The Drug Office of the Hong Kong Department of Health will review the application materials.
If any problems are found during the review, the applicant will be asked to supplement or modify the materials.
4. Approval

If the review is passed, the Drug Office of the Hong Kong Department of Health will issue a drug registration certificate.
The drug registration certificate is the legal basis for the sale, offer for sale, distribution, or possession of drugs in Hong Kong.
5. Post-registration

Drug registrants must comply with relevant Hong Kong regulations to ensure the safety, efficacy, and quality of drugs.
The Drug Office of the Hong Kong Department of Health will conduct regular inspections and supervision of registered drugs.
The general timeline for drug registration in Hong Kong is as follows:

New drugs: 18-24 months
Generic drugs: 12 months
Generic name drugs: 12 months
Biological products: 270 months
Traditional Chinese medicines: 18-360 months
Please note that the above time is for reference only, and the actual approval time may vary.

Here are some suggestions to help you shorten the drug registration time in Hong Kong:

Consult the Drug Office of the Hong Kong Department of Health or a professional drug registration consulting agency before submitting your application.
Ensure that your application materials are complete, accurate, and comply with relevant Hong Kong regulations.
Choose the appropriate registration path.
Maintain close communication with the Drug Office of the Hong Kong Department of Health.
Here are some resources for drug registration in Hong Kong:

Website of the Drug Office of the Hong Kong Department of Health: https://www.drugoffice.gov.hk/eps/do/en/level.html
Guidelines for Registration of Pharmaceutical Products/Substances: https://www.ppbhk.org.hk/
Introduction to Drug Registration in Hong Kong: https://www.dh.gov.hk/english/useful/useful_registration/useful_registration.html
I hope the above information is helpful to you.

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评估您的药品是否符合香港药品注册要求
准备所有必要的注册资料
与香港卫生署进行沟通和协调
协助您获得香港药品注册证书
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